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STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity (STEP 6)

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Semaglutide

Placebo (semaglutide)

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

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

Inclusion Criteria:

Male or female, age more than or equal to 18 years at the time of signing informed consent
BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)
History of at least one self-reported unsuccessful dietary effort to lose body weight
For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive)

Exclusion Criteria:

A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m^2 (less than 60 mL/min/1.73 m^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Semaglutide 2.4 mg

Placebo (semaglutide 2.4 mg)

Semaglutide 1.7 mg

Placebo (semaglutide 1.7 mg)

Arm Description

Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue semaglutide 2.4 mg until week 68.

Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0, 1.7 and 2.4 mg/week), until the target dose (2.4 mg) is reached after 16 weeks. Participants will continue placebo (semaglutide 2.4 mg) until week 68.

Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.

Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.

Outcomes

Primary Outcome Measures

Change in Body Weight (%)

Change from baseline (week 0) in body weight for 'in-trial' observation period at week 68 is presented. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%

Number of participants who achieved greater than or equal to (≥) 5% weight loss at week 68 for in-trial observation period is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 5% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 5% weight loss. In-trial observation period: the uninterrupted time interval from the start of randomisation (week 0) to last trial-related subject-site contact (week 75).

Secondary Outcome Measures

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%

Number of participants who achieved greater than or equal to (≥) 10% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 10% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 10% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%

Number of participants who achieved greater than or equal to (≥) 15% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 15% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 15% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%

Number of participants who achieved greater than or equal to (≥) 20% weight loss at week 68 is presented. In the reported data, 'Yes' infers the number of participants who have achieved ≥ 20% weight loss, whereas 'No' infers the number of participants who have not achieved ≥ 20% weight loss. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest

Change in waist circumference measured midway between the lower rib margin and the iliac crest from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline

Change in Waist circumference measured according to the JASSO guideline from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Body Weight (Kg)

Change in body weight from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Body Mass Index (BMI)

Change in BMI from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Visceral Fat Area (VFA) (%)

Change in VFA from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)

Change in HbA1c (%)

Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in HbA1c (mmol/Mol)

Change in Fasting Plasma Glucose

Change in fasting plasma glucose from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.

Change in Fasting Serum Insulin-ratio to Baseline

Change in fasting serum insulin measured as milli-international units per milliliter (mIU/mL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Systolic Blood Pressure

Change in systolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Diastolic Blood Pressure

Change in diastolic blood pressure from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Total Cholesterol-ratio to Baseline

Change in total cholesterol measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in High-density Lipoproteins (HDL)-Ratio to Baseline

Change in HDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Low-density Lipoproteins (LDL)-Ratio to Baseline

Change in LDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.

Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline

Change in VLDL measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomization to last trial-related subject-site contact.

Change in Free Fatty Acids-ratio to Baseline

Change in free fatty acids measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Triglycerides-ratio to Baseline

Change in triglycerides measured as milligrams per deciliter (mg/dL) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

Change in hsCRP measured in milligram per ilitre (mg/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline

Change in plasminogen activator inhibitor-1 (PAI-1) activity measured in arbritary units per milliliter (AU/ml) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Change in Short Form 36 v2.0 Acute (SF-36) Score

SF-36 is a 36-item patient-reported survey of patient health that measures participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured eight domains of functional health and well-being as well as 2 component summary scores (physical component summary and mental component summary). This endpoint shows results for all the domains. The 0-100 scale scores from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of scores in the 2009 U.S. general population. In metric of norm-based scores, 50 and 10 corresponds to mean and standard deviation respectively. Change from week 0 in domain scores and component summary scores were evaluated at week 68. A positive change score indicates an improvement since baseline. These endpoints were evaluated based on data from in-trial observation period which is uninterrupted time interval from randomisation to last contact with trial site.

Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score

The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 20-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. This endpoint shows results for 'physical function score' physical and psychosocial domains, and for total'. The endpoint was evaluated based on the data from in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.

Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score

The number of participants experiencing a meaningful within participant improvement in SF-36 Physical function after 68 weeks was determined based on 3.7 threshold. The threshold of 3.7 is specific for overweight or obese population included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on Food and Drug Administration (FDA) recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.

Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score

The number of participants experiencing a meaningful within participant improvement in IWQOL-Lite-CT physical function after 68 weeks was determined based on thresholds of 14.6. The threshold of 14.6 is specific for the population with overweight or obesity included in the study and calculated using patient global rating anchor questionnaires to reflect participants' own perspective based on FDA recommendations. In the reported data, "Yes" infers the number of participants who have achieved an improvement in score greater than or equal to the threshold and "No" infers the number of participants who have not achieved an improvement in score greater than or equal to the threshold. The endpoint was evaluated based on in-trial observation period which is the uninterrupted time interval from randomisation to last contact with trial site.

Number of Participants Who Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol)

Number of participants who achieved HbA1c <7% (53 mmol/mol) at week 68 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values less than the 7% and "No" infers the number of participants who have not achieved HbA1c values less than the 7%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)

Number of participants who achieved HbA1c ≤6.5% (48 mmol/mol) at week 68 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values less than or equal to 6.5% and "No" infers the number of participants who have not achieved HbA1c values less than or equal to 6.5%. The endpoint was evaluated based on the data from in-trial observation period which was defined as the uninterrupted time interval from the start of randomisation to last trial-related subject-site contact.

Number of Treatment-emergent AEs

An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event with onset during the on-treatment observation period. On-treatment observation period: the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

Number of Serious Adverse Events

A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. SAE results occurred from week 0 to week 75 is presented based on the on-treatment observation, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals. Off-treatment time interval: time period with at least two consecutive missed doses.

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes

Hypoglycaemic episodes with onset during on-treatment observation period were considered treatment-emergent. Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemia episodes with onset during on-treatment observation period were presented. Severe hypoglycaemia: episode requiring assistance of another person to administer carbohydrate, glucagon or take other corrective actions. plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by low PG concentration. BG confirmed symptomatic hypoglycaemia: episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. On-treatment observation period is interval from date of first trial product administration (week 0) to date of last trial product administration (week 68) plus 7-week follow-up period and excluding any off-treatment time intervals.

Change in Pulse

Change in pulse from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.

Change in Amylase: Ratio to Baseline

Change in amylase measured in units/liter (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.

Change in Lipase: Ratio to Baseline

Change in lipase measured in units/litre (U/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.

Change in Calcitonin: Ratio to Baseline

Change in calcitonin measured in nanogram/litre (ng/L) from baseline (week 0) to week 68 is presented as ratio to baseline. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.

Change in QTCF Interval

Change in QTCF Interval from baseline (week 0) to week 68 is presented. The endpoint was evaluated based on the data from on-treatment observation period, which was defined as the interval from the date of first trial product administration (week 0) to the date of last trial product administration (week 68) plus a 7 week follow-up period and excluding any off-treatment time intervals.

Full Information

NCT ID

NCT03811574

First Posted

January 18, 2019

Last Updated

February 23, 2022

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03811574

Brief Title

STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

Acronym

STEP 6

Official Title

Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 21, 2019 (Actual)

Primary Completion Date

November 20, 2020 (Actual)

Study Completion Date

November 20, 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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study will look at the change in participants' body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants are three times as likely to get semaglutide as "dummy" medicine. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skinfold in the stomach, thigh or upper arm. The study will last for about one and a half years. Participants will have 14 clinic visits and 11 phone calls with the study doctor.

6. Conditions and Keywords

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

Overweight, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Sponsor staff involved in the clinical trial is masked according to company standard procedures

Allocation

Randomized

Enrollment

401 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semaglutide 2.4 mg

Arm Type

Experimental

Arm Description

Arm Title

Placebo (semaglutide 2.4 mg)

Arm Type

Placebo Comparator

Arm Description

Arm Title

Semaglutide 1.7 mg

Arm Type

Experimental

Arm Description

Participants will receive semaglutide injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue semaglutide 1.7 mg until week 68.

Arm Title

Placebo (semaglutide 1.7 mg)

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo (semaglutide) injections once-weekly for 68 weeks. Participants will be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 1.7 mg/week), until the target dose (1.7 mg) is reached after 12 weeks. Participants will continue placebo (semaglutide 1.7) until week 68.

Intervention Type

Drug

Intervention Name(s)

Semaglutide

Intervention Description

Semaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.

Intervention Type

Drug

Intervention Name(s)

Placebo (semaglutide)

Intervention Description

Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.

Primary Outcome Measure Information:

Title

Change in Body Weight (%)

Description

Time Frame

Baseline (week 0), week 68

Title

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%

Description

Time Frame

At week 68

Secondary Outcome Measure Information:

Title

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%

Description

Time Frame

At week 68

Title

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%

Description

Time Frame

At week 68

Title

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%

Description

Time Frame

At week 68

Title

Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Weight (Kg)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Body Mass Index (BMI)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Visceral Fat Area (VFA) (%)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in HbA1c (%)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in HbA1c (mmol/Mol)

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Fasting Plasma Glucose

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Fasting Serum Insulin-ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Systolic Blood Pressure

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Diastolic Blood Pressure

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Total Cholesterol-ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in High-density Lipoproteins (HDL)-Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Low-density Lipoproteins (LDL)-Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Very Low-density Lipoproteins (VLDL)-Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Free Fatty Acids-ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Triglycerides-ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Short Form 36 v2.0 Acute (SF-36) Score

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score

Description

Time Frame

Baseline (week 0) to week 68

Title

Number of Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score

Description

Time Frame

At week 68

Title

Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (5-items) Score

Description

Time Frame

At week 68

Title

Number of Participants Who Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol)

Description

Time Frame

At week 68

Title

Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)

Description

Time Frame

At week 68

Title

Number of Treatment-emergent AEs

Description

Time Frame

Week 0 to week 75

Title

Number of Serious Adverse Events

Description

Time Frame

Week 0 to week 75

Title

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes

Description

Time Frame

Week 0 to week 75

Title

Change in Pulse

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Amylase: Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Lipase: Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in Calcitonin: Ratio to Baseline

Description

Time Frame

Baseline (week 0) to week 68

Title

Change in QTCF Interval

Description

Time Frame

Baseline (week 0) to week 68

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, age more than or equal to 18 years at the time of signing informed consent BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D) History of at least one self-reported unsuccessful dietary effort to lose body weight For subjects with T2D at screening (Japan only): a) Diagnosed with T2D more than or equal to 180 days prior to the day of screening. b) HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) Exclusion Criteria: A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening For subjects with T2D at screening (Japan only): a) Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m^2 (less than 60 mL/min/1.73 m^2 in subjects treated with sodium-glucose co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening. b) Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Adachi-ku, Tokyo

ZIP/Postal Code

123-0845

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Bunkyo-ku, Tokyo

ZIP/Postal Code

113-8655

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chitose, Hokkaido

ZIP/Postal Code

066-0032

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chuo-ku, Tokyo

ZIP/Postal Code

103-0002

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Chuo-ku,Tokyo

ZIP/Postal Code

103-0025

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Gunma

ZIP/Postal Code

373-0036

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Ibaraki

ZIP/Postal Code

311-0113

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kanagawa

ZIP/Postal Code

232-0064

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kashiwara-shi, Osaka

ZIP/Postal Code

582-0005

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kobe, Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Kumamoto

ZIP/Postal Code

862-0976

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Miyazaki

ZIP/Postal Code

880-0034

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Sapporo-shi, Hokkaido

ZIP/Postal Code

004-0004

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Shimotsuke-shi, Tochigi

ZIP/Postal Code

329-0433

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Suita-shi, Osaka

ZIP/Postal Code

565-0853

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

103-0027

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

103-0028

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

125-0054

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Tokyo

ZIP/Postal Code

160-0008

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Toyama-shi, Toyama

ZIP/Postal Code

930-0194

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Yamato-shi, Kanagawa

ZIP/Postal Code

242-0004

Country

Japan

Facility Name

Novo Nordisk Investigational Site

City

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novo Nordisk Investigational Site

City

Yangsan

ZIP/Postal Code

626-770

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

https://www.novonordisk-trials.com

Citations:

PubMed Identifier

33667417

Citation

Davies M, Faerch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I; STEP 2 Study Group. Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. Lancet. 2021 Mar 13;397(10278):971-984. doi: 10.1016/S0140-6736(21)00213-0. Epub 2021 Mar 2.

Results Reference

result

PubMed Identifier

35131037

Citation

Kadowaki T, Isendahl J, Khalid U, Lee SY, Nishida T, Ogawa W, Tobe K, Yamauchi T, Lim S; STEP 6 investigators. Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial. Lancet Diabetes Endocrinol. 2022 Mar;10(3):193-206. doi: 10.1016/S2213-8587(22)00008-0. Epub 2022 Feb 4.

Results Reference

derived

Learn more about this trial

STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

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STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity (STEP 6)

Overweight, Obesity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

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