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Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

semaglutide

liraglutide

placebo

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

18 Years - undefined (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 - Male or female, age 18 years or older at the time of signing inform consent - Body mass index (BMI) equal or above 30.0 kg/m^2 at the screening visit - At least one unsuccessful weight loss attempt per investigator judgement Exclusion Criteria: - A HbA1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - Treatment with glucose lowering agent(s) within 90 days before screening - Screening calcitonin equal to or above 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - History of pancreatitis (acute or chronic) - Obesity induced by endocrine disorders (e.g. Cushing Syndrome) - Treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - Previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - History of major depressive disorder within 2 years before randomisation - Any lifetime history of a suicidal attempt - 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 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Sema 0.05 mg

Sema 0.1 mg

Sema 0.2 mg

Sema 0.3 mg

Sema 0.4 mg

Sema 0.3 mg (fast dose escalation)

Sema 0.4 mg (fast dose escalation)

Lira 3.0 mg

Placebo Sema 0.05 mg

Placebo Sema 0.1 mg

Placebo Sema 0.2 mg

Placebo Sema 0.3 mg

Placebo Sema 0.4 mg

Placebo Sema 0.3 mg (fast dose escalation)

Placebo Sema 0.4 mg (fast dose escalation)

Placebo Lira 3.0 mg

Arm Description

Dose 0.05 mg

Dose 0.05 or 0.1 mg with dose escalation every fourth week

Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week

Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week

Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week

Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week

Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week

Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week

Placebo arm matching active arm Sema 0.05 mg

Placebo arm matching active arm Sema 0.1 mg

Placebo arm matching active arm Sema 0.2 mg

Placebo arm matching active arm Sema 0.3 mg

Placebo arm matching active arm Sema 0.4 mg

Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)

Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)

Placebo arm matching active arm Lira 3.0 mg

Outcomes

Primary Outcome Measures

Relative Change in Body Weight (%)

Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.

Secondary Outcome Measures

Participants With Weight Loss of ≥5% of Baseline Body Weight

Presented results are percentage of participants who lost more than or equal to 5% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.

Participants With Weight Loss of ≥10% of Baseline Body Weight

Presented results are percentage of participants who lost more than or equal to 10% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.

Change in Body Weight (kg)

Change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in Waist Circumference

Change from baseline (week 0) in waist circumference was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist circumference as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in Waist to Hip Circumference Ratio

Change from baseline (week 0) in waist to hip circumference ratio was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist to hip circumference ratio as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in BMI

Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline BMI as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in HbA1c

Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline HbA1c as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in FPG

Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline FPG as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)

The categorisation of glycaemic status as described in the protocol was not aligned with the usual diagnosis criteria which require repeated testing of blood glucose to confirm the diagnosis and allows for the diagnosis to be made based on random glucose assessments and/or 2-hour glucose assessments during an oral glucose tolerance test. Therefore, data were not collected for this outcome measure.

Change in SBP

Change from baseline (week 0) in systolic blood pressure (SBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline SBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in DBP

Change from baseline (week 0) in diastolic blood pressure (DBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline DBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)

Change from baseline (week 0) in lipids (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and respective baseline lipid value as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. Free fatty acid (FFA) results are not presented as the values were considered invalid. The shipment of the samples to be tested for FFA was not as per the requirement.

Change in hsCRP

Change from baseline (week 0) in high-sensitivity C-reactive protein (hsCRP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline hsCRP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in IWQoL Lite

The planned analyses of the Impact of Weight on Quality of Life Lite (IWQoL-Lite) for Clinical Trials scores were not performed. The measure was still under development, and Novo Nordisk had not obtained a validated scoring of the instrument by the time of analysis of the trial results. Therefore, the total and subdomain scores on the IWQoL-Lite could not be provided.

Change in SF-36

Short Form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the in-trial observation period.

Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)

Participants' status on receiving concomitant medication (antihypertensive and lipid-lowering medications) at week 0 (yes/no) and week 52 (decreased, no change, increased or missing) are presented. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Compliance With Nutritional Counselling

This outcome measure presents "nutritional compliance results" recorded at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52. Nutritional compliance was recorded on a 0 to 10 numeric rating scale (NRS), with higher scores representing better compliance.

Number of AEs During the Trial

Adverse events (AEs) were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Number of Hypoglycaemic Episodes During the Trial

Hypoglycaemic episodes were identified by either: 1) Subject reporting of symptoms of hypoglycaemia (low blood sugar) or 2) fasting plasma glucose (FPG) values ≤3.9 mmol/L (70 mg/dL) from blood sampling at site visits. Hypoglycaemic episodes were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week

Presented results are the number of nausea, vomiting, diarrhoea, and constipation events recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score

This outcome measure presents results recorded at week 52. If a participant experienced an event of nausea within 24 hours prior to a site visit, a nausea questionnaire had to be completed. Participants experiencing such events were to answer 5 different categories in the questionnaire ('duration of nausea', 'time from the latest injection of trial product to the onset of nausea', 'time from last food intake to the onset of nausea', 'nausea accompanied by vomiting (yes/no)' and 'severity of nausea (worst during episode)'). Severity of nausea was recorded on a 0 to 10 numeric rating scale (NRS), where 0 = 'No nausea' and 10 = 'Nausea as bad as it could be'. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Change in ECG

Number of participants with electrocardiogram (ECG) results, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" was recorded at baseline (week 0) and week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Pulse

Change from baseline (week 0) in pulse rate was evaluated at week 52. Analysis of observed data using a mixed model for repeated measurements (MMRM) with treatment, region and sex as factors and baseline pulse as covariate, all nested within visit. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Haematology: Haemoglobin

Change from baseline (week 0) in haemoglobin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Haematology: Haematocrit

Change from baseline (week 0) in haematocrit was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Haematology: Thrombocytes, Leucocytes and Differential Count

Change from baseline (week 0) in haematological parameters, "thrombocytes, leucocytes and differential cell count (eosinophils, neutrophils, basophils, monocytes and lymphocytes)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Haematology: Erythrocytes

Change from baseline (week 0) in erythrocytes was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Biochemistry: Creatinine and Bilirubin (Total)

Change from baseline (week 0) in biochemistry parameters, "creatinine and bilirubin (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP

Change from baseline (week 0) in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)

Change from baseline (week 0) in biochemistry parameters, "urea, sodium, potassium and calcium (total)" were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Biochemistry: Albumin

Change from baseline (week 0) in albumin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Biochemistry: Calcitonin

Change from baseline (week 0) in calcitonin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Biochemistry: TSH

Change from baseline (week 0) in thyroid stimulating hormone (TSH) was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Mental Health Assessed by C-SSRS

Presented results are the number of participants with Columbia Suicidality Severity Rating Scale (C-SSRS) results recorded during baseline (week 0) and post baseline (week 4-52) visits. For classification of the events reported on the C-SSRS, the following categories were used: 1) Suicidal ideation, 2) Suicidal behaviour and 3) Non-suicidal self-injurious behaviour. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Change in Mental Health Assessed by PHQ-9

Patient health questionnaire-9 (PHQ-9) was recorded at baseline (week 0) and week 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. On the PHQ-9, the participant rates the frequency of 9 items on a scale from 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.

Anti-semaglutide Antibodies During and After Treatment

Participants were tested for anti-semaglutide antibodies from week 0 (post treatment) to week 52 (at weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52). This outcome measure is applicable only for the semaglutide treatment arms.

Full Information

NCT ID

NCT02453711

First Posted

May 21, 2015

Last Updated

April 14, 2020

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT02453711

Brief Title

Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

Official Title

Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2015 (Actual)

Primary Completion Date

March 30, 2017 (Actual)

Study Completion Date

April 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.

6. Conditions and Keywords

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

Metabolism and Nutrition Disorder, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

957 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sema 0.05 mg

Arm Type

Experimental

Arm Description

Dose 0.05 mg

Arm Title

Sema 0.1 mg

Arm Type

Experimental

Arm Description

Dose 0.05 or 0.1 mg with dose escalation every fourth week

Arm Title

Sema 0.2 mg

Arm Type

Experimental

Arm Description

Dose 0.05, 0.1 or 0.2 mg with dose escalation every fourth week

Arm Title

Sema 0.3 mg

Arm Type

Experimental

Arm Description

Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every fourth week

Arm Title

Sema 0.4 mg

Arm Type

Experimental

Arm Description

Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every fourth week

Arm Title

Sema 0.3 mg (fast dose escalation)

Arm Type

Experimental

Arm Description

Dose 0.05, 0.1, 0.2 or 0.3 mg with dose escalation every second week

Arm Title

Sema 0.4 mg (fast dose escalation)

Arm Type

Experimental

Arm Description

Dose 0.05, 0.1, 0.2, 0.3, or 0.4 mg with dose escalation every second week

Arm Title

Lira 3.0 mg

Arm Type

Active Comparator

Arm Description

Dose 0.6, 1.2, 1.8, 2.4, 3.0 mg with dose escalation every week

Arm Title

Placebo Sema 0.05 mg

Arm Type

Placebo Comparator

Arm Description

Placebo arm matching active arm Sema 0.05 mg

Arm Title

Placebo Sema 0.1 mg

Arm Type

Placebo Comparator

Arm Description

Placebo arm matching active arm Sema 0.1 mg

Arm Title

Placebo Sema 0.2 mg

Arm Type

Placebo Comparator

Arm Description

Placebo arm matching active arm Sema 0.2 mg

Arm Title

Placebo Sema 0.3 mg

Arm Type

Placebo Comparator

Arm Description

Placebo arm matching active arm Sema 0.3 mg

Arm Title

Placebo Sema 0.4 mg

Arm Type

Placebo Comparator

Arm Description

Placebo arm matching active arm Sema 0.4 mg

Arm Title

Placebo Sema 0.3 mg (fast dose escalation)

Arm Type

Placebo Comparator

Arm Description

Placebo arm matching active arm Sema 0.3 mg (fast dose escalation)

Arm Title

Placebo Sema 0.4 mg (fast dose escalation)

Arm Type

Placebo Comparator

Arm Description

Placebo arm matching active arm Sema 0.4 mg (fast dose escalation)

Arm Title

Placebo Lira 3.0 mg

Arm Type

Placebo Comparator

Arm Description

Placebo arm matching active arm Lira 3.0 mg

Intervention Type

Drug

Intervention Name(s)

semaglutide

Intervention Description

Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Relative Change in Body Weight (%)

Description

Time Frame

Week 0, Week 52

Secondary Outcome Measure Information:

Title

Participants With Weight Loss of ≥5% of Baseline Body Weight

Description

Time Frame

Week 52

Title

Participants With Weight Loss of ≥10% of Baseline Body Weight

Description

Time Frame

Week 52

Title

Change in Body Weight (kg)

Description

Time Frame

Week 0, Week 52

Title

Change in Waist Circumference

Description

Time Frame

Week 0, Week 52

Title

Change in Waist to Hip Circumference Ratio

Description

Time Frame

Week 0, Week 52

Title

Change in BMI

Description

Time Frame

Week 0, Week 52

Title

Change in HbA1c

Description

Time Frame

Week 0, Week 52

Title

Change in FPG

Description

Time Frame

Week 0, Week 52

Title

Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)

Description

Time Frame

Week 0, Week 52

Title

Change in SBP

Description

Time Frame

Week 0, Week 52

Title

Change in DBP

Description

Time Frame

Week 0, Week 52

Title

Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)

Description

Time Frame

Week 0, Week 52

Title

Change in hsCRP

Description

Time Frame

Week 0, Week 52

Title

Change in IWQoL Lite

Description

Time Frame

Week 0, Week 52

Title

Change in SF-36

Description

Time Frame

Week 0, Week 52

Title

Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)

Description

Time Frame

Week 0, Week 52

Title

Compliance With Nutritional Counselling

Description

Time Frame

Week 4-52

Title

Number of AEs During the Trial

Description

Adverse events (AEs) were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.

Time Frame

Week 0-59

Title

Number of Hypoglycaemic Episodes During the Trial

Description

Time Frame

Week 0-59

Title

Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week

Description

Time Frame

Week 0-59

Title

Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score

Description

Time Frame

Week 52

Title

Change in ECG

Description

Time Frame

Week 0, week 52

Title

Change in Pulse

Description

Time Frame

Week 0, week 52

Title

Change in Haematology: Haemoglobin

Description

Time Frame

Week 0, week 52

Title

Change in Haematology: Haematocrit

Description

Time Frame

Week 0, week 52

Title

Change in Haematology: Thrombocytes, Leucocytes and Differential Count

Description

Time Frame

Week 0, week 52

Title

Change in Haematology: Erythrocytes

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry: Creatinine and Bilirubin (Total)

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry: Albumin

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry: Calcitonin

Description

Time Frame

Week 0, week 52

Title

Change in Biochemistry: TSH

Description

Time Frame

Week 0, week 52

Title

Change in Mental Health Assessed by C-SSRS

Description

Time Frame

Week 0 and Week 4-59

Title

Change in Mental Health Assessed by PHQ-9

Description

Time Frame

Week 0, week 52

Title

Anti-semaglutide Antibodies During and After Treatment

Description

Time Frame

Week 0-52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20011

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Elkridge

State/Province

Maryland

ZIP/Postal Code

21075-6437

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Wadsworth

State/Province

Ohio

ZIP/Postal Code

44281

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620-7352

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlington

State/Province

Virginia

ZIP/Postal Code

22206

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

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

Merewether

State/Province

New South Wales

ZIP/Postal Code

2291

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Heidelberg Heights

State/Province

Victoria

ZIP/Postal Code

3081

Country

Australia

Facility Name

Novo Nordisk Investigational Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

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

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

Novo Nordisk Investigational Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2V 4J2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3S 2N6

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1G 1A7

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

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 5G8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8M 1K7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4P 1P2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4N 2W2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Dresden

ZIP/Postal Code

01219

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Duisburg

ZIP/Postal Code

47051

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Saint Ingbert-Oberwürzbach

ZIP/Postal Code

66386

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Stuttgart

ZIP/Postal Code

70378

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Wangen

ZIP/Postal Code

88239

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Kfar-Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Petah-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Petah-Tikva

ZIP/Postal Code

49372

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

101990

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

109240

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Moscow

ZIP/Postal Code

117036

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Novosibirsk

ZIP/Postal Code

630047

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

191015

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Tumen

ZIP/Postal Code

625023

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Voronezh

ZIP/Postal Code

394018

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Novo Nordisk Investigational Site

City

Bristol

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

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

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Luton

ZIP/Postal Code

LU4 0DZ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Norwich

ZIP/Postal Code

NR4 7TJ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Rotherham

ZIP/Postal Code

S651DA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30993900

Citation

Kolotkin RL, Williams VSL, Ervin CM, Williams N, Meincke HH, Qin S, von Huth Smith L, Fehnel SE. Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version. Clin Obes. 2019 Jun;9(3):e12310. doi: 10.1111/cob.12310. Epub 2019 Apr 16.

Results Reference

background

PubMed Identifier

30122305

Citation

O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

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Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

Metabolism and Nutrition Disorder, Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

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