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Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

Primary Purpose

Hepatobiliary Disorders, Non-alcoholic Steatohepatitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Placebo

About this trial

This is an interventional treatment trial for Hepatobiliary Disorders

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol described pre-screening activities which require a separate informed consent. - Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive)) at the time of signing informed consent - Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening - Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type 1 diabetes according to medical records - HbA1c above 10% at screening - History or presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤ 25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide 0,1 mg

Semaglutide 0,2 mg

Semaglutide 0,4 mg

Placebo 1

Placebo 2

Placebo 3

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)

NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1 and hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning ranges from 0-2; lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Secondary Outcome Measures

Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)

NASH resolution defined by NASH clinical research network as lobular inflammation of 0 or 1; hepatocellular ballooning reduced to 0; both criteria were necessary conditions. Hepatocellular ballooning range: 0-2; lobular inflammation range: 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Worsening of fibrosis defined by an increase in fibrosis at least one stage of Kleiner fibrosis classification: fibrosis stages range from 0-4, higher scores indicate greater fibrosis (0=None, 4=Cirrhosis). Endpoint was evaluated based on data from in-trial period which started on date of randomisation visit and ended on first of following dates (both inclusive):1) follow-up visit (Week 79); 2) withdrawal of consent; 3)last contact with participant (for participants lost to follow-up); 4)death.

Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)

Percentage of participants who had worsened, improved or had no change in total NAS from baseline to week 72 is presented. Worsening is defined as an increase of at least 1 in the NAS; Improvement is defined as a decrease of at least 1 in the NAS; while no change corresponds to no change in NAS from baseline to week 72. NAS is calculated as the sum of scores for steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocyte ballooning (0 to 2). Therefore, it is assessed on a scale of 0-8, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Percentage of Participants With Change in Steatosis

Percentage of participants who had improved, worsened, or had no change in steatosis from baseline to week 72 is presented. Steatosis was assessed on a scale of 0-3, with higher scores indicating more severe steatosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Percentage of Participants With Change in Lobular Inflammation

Percentage of participants who had improved, worsened, or had no change in lobular inflammation from baseline to week 72 is presented. Lobular inflammation was assessed on a scale of 0-3, with higher scores indicating more severe lobular inflammation. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Percentage of Participants With Change in Hepatocyte Ballooning

Percentage of participants who had improved, worsened, or had no change in hepatocyte ballooning from baseline to week 72 is presented. Hepatocyte ballooning was assessed on a scale of 0-2, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification

Percentage of participants who had improved, worsened, or had no change in fibrosis stage from baseline to week 72 is presented. The degree of fibrosis is described by the Kleiner fibrosis staging system, ranging from F0 (absence of fibrosis), F1 (portal/perisinusoidal fibrosis), F2 (perisinusoidal and portal/periportal fibrosis), F3 (septal or bridging fibrosis) through F4 (cirrhosis). The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score

Percentage of participants who had improved, worsened, or had no change in the activity component of the SAF score from baseline to week 72 is presented. SAF score was assessed on a scale of 0-4, with higher scores indicating more severe disease. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Fibrosis-4 Score

Change in fibrosis-4 score is presented as ratio to baseline. Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: Fibrosis-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A Fibrosis-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in NAFLD Fibrosis Score (NFS)

Change in NFS from baseline to week 72 is presented. NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * body mass index (BMI) (kg/m^2) + 1.13 * hyperglycaemia (yes/no) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio + 0.013 × platelet count (*10^9/L) - 0.66 * albumin (g/dL). The score is used to classify the probability of fibrosis. A score a) < -1.5 indicates a low probability, b) > -1.5 to < 0.67 indicates intermediate probability, and a score of c) > 0.67 indicates a high probability of liver fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Alanine Aminotransferase (ALT)

Change in ALT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Aspartate Aminotransferase (AST)

Change in AST (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Gamma Glutamyl Transferase (GGT)

Change in GGT (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Albumin

Change in albumin (measured as grams per deciliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in International Normalized Ratio (INR)

Change in INR is presented as ratio to baseline. INR is the ratio of measured prothrombin time over normal prothrombin time and it evaluates the extrinsic coagulation pathway (vitamin K dependent clotting factors II; V, VII, IX and X). These clotting factors are synthesised in the liver, thus INR is used as a marker of liver synthesis function. The therapeutic INR range varies, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Enhanced Liver Fibrosis (ELF)

Change in ELF from baseline to week 72 is presented. The ELF discriminant score was derived as a log-linear combination of the markers hyaluronic acid (HA), amino-terminal propeptide of type III collagen (PIIINP) and tissue inhibitor of metalloproteinase 1 (TIMP1). ELF score = -7.412 + 0.681 × ln(HA (nanograms per millilitre (ng/mL)) + 0.775 × ln(P3NP (ng/mL)) + 0.494 × ln(TIMP1 (ng/mL)). ELF score: a) < 7.7: no to mild fibrosis; b) ≥ 7.7 - < 9.8: Moderate fibrosis; c) ≥ 9.8 - < 11.3: Severe fibrosis; d) ≥ 11.3: Cirrhosis. A negative change from baseline indicates decreased fibrosis. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Cytokeratin 18 (CK-18) Fragments

Change in CK-18 fragments (M30, M65) (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in microRNA 122 (miR-122)

Change in miR-122 (measured as 1/microliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Interleukin-1 Receptor (IL-1R) Antagonist

Change in interleukin-1 receptor (IL-1R) antagonist (measured as picograms per milliliter) antagonist is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Monocyte Chemoattractant Protein 1 (MCP-1)

Change in MCP-1 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Fibroblast Growth Factor 21 (FGF-21)

Change in FGF-21 (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Liver Stiffness Assessed by FibroScan®

Change in liver stiffness (measured as kilopascal (kPa)) assessed by FibroScan® is presented as ratio to baseline. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Liver Steatosis Assessed by FibroScan®

Change in liver steatosis assessed by FibroScan® from baseline to week 72 is presented. FibroScan® is a specialized ultrasound machine for the liver. It measures fibrosis (scarring) and steatosis (fatty change) in the liver. Fatty change is fat building up in the liver cells. To assess liver steatosis, the controlled attenuation parameter (CAP; giving an estimate of ultrasound attenuation ∼3.5 MegaHertz (MHz)) is available with the M probe of the FibroScan. The CAP score is measured in decibels per meter (dB/m). It ranges from 100 to 400 dB/m, with higher scores indicating higher amount of liver with fatty change. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)

Percentage of participants with weight loss of greater than or equal to (≥) 5% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 5% weight loss; 'No' infers percentage of participants who have not achieved ≥ 5% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).

Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)

Pentage of participants with weight loss of ≥ 10% of baseline body weight at 72 weeks is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death. In the below table, 'Yes' infers percentage of participants who have achieved ≥ 10% weight loss; 'No' infers percentage of participants who have not achieved ≥ 10% weight loss at 72 weeks and 'Missing' refers to percentage of participants with data missing due to different reasons (lost to follow-up, withdrawal).

Change in Body Weight

Change in body weight from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Waist Circumference

Change in waist circumference from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Body Mass Index (BMI)

Change in BMI from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Glycosylated Haemoglobin (HbA1c) (%-Point)

Change in HbA1c (measured as percentage point of HbA1c) from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in HbA1c (Millimoles Per Mole)

Change in HbA1c from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Fasting Plasma Glucose (FPG)

Change in FPG from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Fasting Glucagon

Change in fasting glucagon (measured as picograms per milliliter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)

Change in HOMA-IR is presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting plasma glucose [mmol/L] x fasting insulin [mmol/L]/ 22.5. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Diastolic Blood Pressure (DBP)

Blood pressure was measured in a sitting position after 5 minutes of rest. Change in DBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Systolic Blood Pressure (SBP)

Blood pressure was measured in a sitting position after 5 minutes of rest. Change in SBP from baseline to week 72 is presented. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Total Cholesterol

Change in total cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Low Density Lipoprotein (LDL) Cholesterol

Change in LDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in High Density Lipoprotein (HDL) Cholesterol

Change in HDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Very Low Density Lipoprotein (VLDL) Cholesterol

Change in VLDL cholesterol (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Triglycerides

Change in triglycerides (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Free Fatty Acids

Change in free fatty acids (measured as millimoles per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in High Sensitivity C-reactive Protein (hsCRP)

Change in hsCRP (measured as milligram per liter) from baseline to week 72 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Short Form 36 (SF-36) Score

Change in SF-36 score from baseline to week 72 is presented. SF-36 measures participant's overall health related quality of life (HRQoL). It is a 36-item generic measure of health status and yields 2 summary scores for physical health and mental health, and 8 domain scores (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional, mental health). The scores 0-100 (where higher scores indicates a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of scores in the 2009 U.S. general population. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Number of Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a clinical trial participant administered or using a medicinal product, whether or not considered related to the medicinal product or usage. All AEs reported here are TEAEs. TEAE is defined as an event that had onset date during the on-treatment period. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half lives of semaglutide); 2) end of the in-trial period.

Number of Treatment-emergent Hypoglycaemic Episodes

Hypoglycaemic episode (blood glucose less than or equal to (<=) 3.9 mmol/L (70 mg/dL) Or greater than (>) 3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms) is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes

Severe or BG confirmed symptomatic hypoglycaemia: episode, severe as per american diabetes association (ADA) classification or BG confirmed by plasma glucose value < 3.1 mmol/L(56mg/dL) with symptoms along with hypoglycaemia. Severe hypoglycaemia: episode requiring assistance of other person to actively administer carbohydrate, glucagon, or take corrective actions. Plasma glucose concentrations may not be available during event, but neurological recovery following return of plasma glucose to normal is sufficient evidence that event was induced by low plasma glucose concentration. Hypoglycaemic episode is treatment emergent if onset of it occurs during on-treatment period: period starting on day of first administration of trial product and ending on day of last dose of trial product+7 days; except for evaluation of AEs; hypoglycaemic episodes for which period ended on date of whatever came first:last dose of trial product + 49 days (7 half-lives of semaglutide); end of in-trial period.

Number of Treatment-emergent Severe Hypoglycaemic Episodes

Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Hypoglycaemic episode is defined as treatment emergent if the onset of the episode occurs during the on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events

Number of participants discontinuing treatment due to gastrointestinal adverse events is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)

Number of participants with occurrence of anti-semaglutide antibodies during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with occurrence of anti-semaglutide antibodies and 'No' infers number of participants without anti-semaglutide antibodies during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)

Number of participants with anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies with in vitro neutralising effect and 'No' infers number of participants without anti-semaglutide antibodies with in vitro neutralising effect during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)

Number of participants with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with anti-semaglutide antibodies cross reacting with native GLP-1 and 'No' infers number of participants without anti-semaglutide antibodies cross reacting with native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)

Number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment is presented. In the below table, 'Yes' infers number of participants with cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 and 'No' infers number of participants without cross-reacting anti-semaglutide binding antibodies with in vitro neutralising effect to native GLP-1 during and after 72 weeks treatment. The endpoint was evaluated based on the data from in-trial period which started on the date of the randomisation visit and ended on the first of the following dates (both inclusive): 1) follow-up visit (Week 79); 2) withdrawal of consent; 3) last contact with participant (for participants lost to follow-up); 4) death.

Change in Pulse From Baseline to Week 72

Change in pulse from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Electrocardiogram (ECG)

A 12-lead ECG was performed at baseline (week 0) and week 72 and categorised as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS). Percentage of participants in each ECG category at week 0 and week 72 are presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: Cardiovascular System

Percentage of participants with change in physical examination (cardiovascular system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System

Percentage of participants with change in physical examination (central and peripheral nervous system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth

Percentage of participants with change in physical examination (gastrointestinal system including mouth) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: General Appearance

Percentage of participants with change in physical examination (general appearance) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck

Percentage of participants with change in physical examination (head, ears, eyes, nose, throat, neck) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: Lymph Node Palpation

Percentage of participants with change in physical examination (lymph node palpation) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: Musculoskeletal System

Percentage of participants with change in physical examination (musculoskeletal system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: Respiratory System

Percentage of participants with change in physical examination (respiratory system) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: Skin

Percentage of participants with change in physical examination (skin) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Percentage of Participants With Change in Physical Examination: Thyroid Gland

Percentage of participants with change in physical examination (thyroid gland) from week -6 to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Haematocrit

Change in haematocrit from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Haemoglobin (g/dL)

Change in haemoglobin from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Haemoglobin (mmol/L)

Change in Leukocytes

Change in leukocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Thrombocytes

Change in thrombocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Erythrocytes

Change in erythrocytes from baseline to week 72 is presented. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Creatinine (mg/dL)

Change in creatinine (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Creatinine (Umol/L)

Change in creatinine (measured as micro mole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Estimated Glomerular Filtration Rate (eGFR)

Change in eGFR (measured as milliliter/minute/1.732 meter square (mL/min/1.73 m^2)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Creatine Kinase

Change in creatine kinase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Urea

Change in urea (measured as milli mole per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Total Bilirubin (mg/dL)

Change in total bilirubin (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Total Bilirubin (Umol/L)

Change in total bilirubin (measured as micromole per liter (umol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Alkaline Phosphatase

Change in alkaline phosphatase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Ferritin

Change in ferritin (measured as microgram per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Sodium (mEq/L)

Change in sodium (measured as milli equivalent per liter (mEq/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Sodium (mmol/L)

Change in sodium (measured as milli mole per liter (mmol/L)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Potassium (mEq/L)

Change in potassium (measured as mEq/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Potassium (mmol/L)

Change in potassium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Calcium (mg/dL)

Change in calcium (measured as milligram per deciliter (mg/dL)) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Calcium (mmol/L)

Change in calcium (measured as mmol/L) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Amylase

Change in amylase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Lipase

Change in lipase (measured as units per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Change in Calcitonin

Change in calcitonin (measured as nanograms per liter) is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment period. On-treatment period: the period starting on the date of first administration of trial product and ending on the date of the last dose of trial product +7 days; except for the evaluation of AEs and hypoglycaemic episodes for which the period ended on the date of whatever came first: 1) last dose of trial product + 49 days (7 half-lives of semaglutide); 2) end of the in-trial period.

Full Information

NCT ID

NCT02970942

First Posted

November 18, 2016

Last Updated

November 15, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02970942

Brief Title

Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

Official Title

This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

November 30, 2016 (Actual)

Primary Completion Date

February 13, 2020 (Actual)

Study Completion Date

March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatobiliary Disorders, Non-alcoholic Steatohepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

320 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide 0,1 mg

Arm Type

Experimental

Arm Title

Semaglutide 0,2 mg

Arm Type

Experimental

Arm Title

Semaglutide 0,4 mg

Arm Type

Experimental

Arm Title

Placebo 1

Arm Type

Placebo Comparator

Arm Title

Placebo 2

Arm Type

Placebo Comparator

Arm Title

Placebo 3

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Once daily administration subcutaneously ( s.c., under the skin)

Primary Outcome Measure Information:

Title

Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No)

Description

Time Frame

After 72 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With at Least One Stage of Liver Fibrosis Improvement With no Worsening of NASH After 72 Weeks (Yes/No)

Description

Time Frame

After 72 weeks

Title

Percentage of Participants With Change in Total NAFLD (Non- Alcoholic Fatty Liver Disease) Activity Score (NAS)

Description

Time Frame

Baseline (week 0), Week 72

Title

Percentage of Participants With Change in Steatosis

Description

Time Frame

Baseline (week 0), Week 72

Title

Percentage of Participants With Change in Lobular Inflammation

Description

Time Frame

Baseline (week 0), Week 72

Title

Percentage of Participants With Change in Hepatocyte Ballooning

Description

Time Frame

Baseline (week 0), Week 72

Title

Percentage of Participants With Change in Fibrosis Stage According to the Kleiner Fibrosis Classification

Description

Time Frame

Baseline (week 0), Week 72

Title

Percentage of Participants With Change in Activity Component of Steatosis-activity-fibrosis (SAF) Score

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Fibrosis-4 Score

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in NAFLD Fibrosis Score (NFS)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Alanine Aminotransferase (ALT)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Aspartate Aminotransferase (AST)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Gamma Glutamyl Transferase (GGT)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Albumin

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in International Normalized Ratio (INR)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Enhanced Liver Fibrosis (ELF)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Cytokeratin 18 (CK-18) Fragments

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in microRNA 122 (miR-122)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Interleukin-1 Receptor (IL-1R) Antagonist

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Monocyte Chemoattractant Protein 1 (MCP-1)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Fibroblast Growth Factor 21 (FGF-21)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Liver Stiffness Assessed by FibroScan®

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Liver Steatosis Assessed by FibroScan®

Description

Time Frame

Baseline (week 0), Week 72

Title

Percentage of Participants With Weight Loss of ≥ 5% of Baseline Body Weight at 72 Weeks (Yes/No)

Description

Time Frame

Week 72

Title

Percentage of Participants With Weight Loss of ≥ 10% of Baseline Body Weight at 72 Weeks (Yes/No)

Description

Time Frame

Week 72

Title

Change in Body Weight

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Waist Circumference

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Body Mass Index (BMI)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Glycosylated Haemoglobin (HbA1c) (%-Point)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in HbA1c (Millimoles Per Mole)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Fasting Plasma Glucose (FPG)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Fasting Glucagon

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Diastolic Blood Pressure (DBP)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Systolic Blood Pressure (SBP)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Total Cholesterol

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Low Density Lipoprotein (LDL) Cholesterol

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in High Density Lipoprotein (HDL) Cholesterol

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Very Low Density Lipoprotein (VLDL) Cholesterol

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Triglycerides

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Free Fatty Acids

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in High Sensitivity C-reactive Protein (hsCRP)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Short Form 36 (SF-36) Score

Description

Time Frame

Baseline (week 0), Week 72

Title

Number of Treatment-emergent Adverse Events (TEAEs)

Description

Time Frame

From week 0 to week 79

Title

Number of Treatment-emergent Hypoglycaemic Episodes

Description

Time Frame

From week 0 to week 79

Title

Number of Treatment-emergent Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemic Episodes

Description

Time Frame

From week 0 to week 79

Title

Number of Treatment-emergent Severe Hypoglycaemic Episodes

Description

Time Frame

From week 0 to week 79

Title

Number of Participants Discontinuing Treatment Due to Gastrointestinal Adverse Events

Description

Time Frame

From week 0 to week 79

Title

Number of Participants With Occurrence of Anti-semaglutide Antibodies During and After 72 Weeks Treatment (Yes/No)

Description

Time Frame

From week 0 to week 79

Title

Number of Participants With Anti-semaglutide Antibodies With in Vitro Neutralising Effect During and After 72 Weeks Treatment (Yes/No)

Description

Time Frame

From week 0 to week 79

Title

Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 During and After 72 Weeks Treatment (Yes/No)

Description

Time Frame

From week 0 to week 79

Title

Number of Participants With Cross-reacting Anti-semaglutide Binding Antibodies With in Vitro Neutralising Effect to Native GLP-1 During and After 72 Weeks Treatment (Yes/No)

Description

Time Frame

From week 0 to week 79

Title

Change in Pulse From Baseline to Week 72

Description

Time Frame

Baseline (week 0), Week 72

Title

Percentage of Participants With Change in Electrocardiogram (ECG)

Description

Time Frame

Baseline (week 0), Week 72

Title

Percentage of Participants With Change in Physical Examination: Cardiovascular System

Description

Time Frame

Week -6, week 72

Title

Percentage of Participants With Change in Physical Examination: Central and Peripheral Nervous System

Description

Time Frame

Week -6, week 72

Title

Percentage of Participants With Change in Physical Examination: Gastrointestinal System Including Mouth

Description

Time Frame

Week -6, week 72

Title

Percentage of Participants With Change in Physical Examination: General Appearance

Description

Time Frame

Week -6, week 72

Title

Percentage of Participants With Change in Physical Examination: Head, Ears, Eyes, Nose, Throat, Neck

Description

Time Frame

Week -6, week 72

Title

Percentage of Participants With Change in Physical Examination: Lymph Node Palpation

Description

Time Frame

Week -6, week 72

Title

Percentage of Participants With Change in Physical Examination: Musculoskeletal System

Description

Time Frame

Week -6, week 72

Title

Percentage of Participants With Change in Physical Examination: Respiratory System

Description

Time Frame

Week -6, week 72

Title

Percentage of Participants With Change in Physical Examination: Skin

Description

Time Frame

Week -6, week 72

Title

Percentage of Participants With Change in Physical Examination: Thyroid Gland

Description

Time Frame

Week -6, week 72

Title

Change in Haematocrit

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Haemoglobin (g/dL)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Haemoglobin (mmol/L)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Leukocytes

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Thrombocytes

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Erythrocytes

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Creatinine (mg/dL)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Creatinine (Umol/L)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Estimated Glomerular Filtration Rate (eGFR)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Creatine Kinase

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Urea

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Total Bilirubin (mg/dL)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Total Bilirubin (Umol/L)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Alkaline Phosphatase

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Ferritin

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Sodium (mEq/L)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Sodium (mmol/L)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Potassium (mEq/L)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Potassium (mmol/L)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Calcium (mg/dL)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Calcium (mmol/L)

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Amylase

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Lipase

Description

Time Frame

Baseline (week 0), Week 72

Title

Change in Calcitonin

Description

Time Frame

Baseline (week 0), Week 72

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Coronado

State/Province

California

ZIP/Postal Code

92118

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92627

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Panorama City

State/Province

California

ZIP/Postal Code

91402

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rialto

State/Province

California

ZIP/Postal Code

92377

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33434

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lakewood Ranch

State/Province

Florida

ZIP/Postal Code

34211

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34240

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21202

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822-2111

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hermitage

State/Province

Tennessee

ZIP/Postal Code

37076

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9302

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rollingwood

State/Province

Texas

ZIP/Postal Code

78746

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Kingswood

State/Province

New South Wales

ZIP/Postal Code

2747

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Fitzroy

State/Province

Victoria

ZIP/Postal Code

3065

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 3P4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4K1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6H 3M1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

Novo Nordisk Investigational Site

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Besançon

ZIP/Postal Code

25000

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Lyon Cedex 4

ZIP/Postal Code

69317

Country

France

Facility Name

Novo Nordisk Investigational Site

City

MARSEILLE cedex 08

ZIP/Postal Code

13285

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Montpellier

ZIP/Postal Code

34090

Country

France

Facility Name

Novo Nordisk Investigational Site

City

NICE cedex 3

ZIP/Postal Code

06202

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Paris

ZIP/Postal Code

75571

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Venissieux

ZIP/Postal Code

69200

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

10676

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Athens

ZIP/Postal Code

GR-11527

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Goudi, Athens

ZIP/Postal Code

GR-115 27

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Larissa

ZIP/Postal Code

GR-41110

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54621

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Thessaloniki

ZIP/Postal Code

GR-54642

Country

Greece

Facility Name

Novo Nordisk Investigational Site

City

Asahikawa-shi, Hokkaido

ZIP/Postal Code

078-8510

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Fukui-shi, Fukui

ZIP/Postal Code

918-8503

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kamigyo-ku, Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kumamoto-shi, Kumamoto

ZIP/Postal Code

862-8655

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Nagakute-shi, Aichi

ZIP/Postal Code

480-1195

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Nara-shi, Nara

ZIP/Postal Code

630-8305

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Nishinomiya-shi, Hyogo

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Osaka-shi, Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Otsu-shi, Shiga

ZIP/Postal Code

520-0804

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Saga-shi, Saga

ZIP/Postal Code

849-8501

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Shimonoseki-shi, Yamaguchi

ZIP/Postal Code

750-0061

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Suita-shi, Osaka

ZIP/Postal Code

564-0013

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Suita-shi, Osaka

ZIP/Postal Code

565-0862

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Takamatsu-shi, Kagawa

ZIP/Postal Code

760-8557

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Toyoake-shi, Aichi

ZIP/Postal Code

470-1192

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Alkmaar

ZIP/Postal Code

1815 JD

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Amstelveen

ZIP/Postal Code

1186 AM

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Delft

ZIP/Postal Code

2625 AD

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Barnaul

ZIP/Postal Code

656045

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

111123

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

121170

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

121293

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

123423

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630005

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Penza

ZIP/Postal Code

440026

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

190013

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

194356

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

194358

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

195067

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

197342

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

199226

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saratov

ZIP/Postal Code

410039

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Stavropol

ZIP/Postal Code

355017

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Stavropol

ZIP/Postal Code

355035

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tomsk

ZIP/Postal Code

634028

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Ulianovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Yoshkar-Ola

ZIP/Postal Code

424004

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Majadahonda

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Stockholm

ZIP/Postal Code

112 81

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bolton

ZIP/Postal Code

BL4 0JR

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 2QQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Derby

ZIP/Postal Code

DE22 3NE

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Glasgow

ZIP/Postal Code

G31 2ER

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Hull

ZIP/Postal Code

HU3 2GZ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Swansea

ZIP/Postal Code

SA2 8PP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to Novo Nordisk disclosure commitment on novonordisk.com

Citations:

PubMed Identifier

33185364

Citation

Newsome PN, Buchholtz K, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal AJ, Sejling AS, Harrison SA; NN9931-4296 Investigators. A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. N Engl J Med. 2021 Mar 25;384(12):1113-1124. doi: 10.1056/NEJMoa2028395. Epub 2020 Nov 13.

Results Reference

result

PubMed Identifier

33039693

Citation

Harrison SA, Calanna S, Cusi K, Linder M, Okanoue T, Ratziu V, Sanyal A, Sejling AS, Newsome PN. Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers. Contemp Clin Trials. 2020 Oct;97:106174. doi: 10.1016/j.cct.2020.106174. Epub 2020 Oct 8.

Results Reference

derived

Learn more about this trial

Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

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Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

Hepatobiliary Disorders, Non-alcoholic Steatohepatitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial