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Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity (STEP 5)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Semaglutide
Placebo (Semaglutide)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

undefined - undefined (Child, 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
  • Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
  • History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion criteria:

  • HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
  • A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Semaglutide

Placebo

Arm Description

Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.

Outcomes

Primary Outcome Measures

Percentage Change From Baseline (Week 0) to Week 104 in Body Weight
Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Number of Participants Who Achieved (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 104 weeks 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. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Secondary Outcome Measures

Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%
Number of participants who achieved >=10% weight loss at 104 weeks 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 outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%
Number of participants who achieved >=15% weight loss at 104 weeks 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 outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%
Number of participants who achieved >=20% weight loss at 104 weeks 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 outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change From Baseline (Week 0) to Week 104 in Waist Circumference
Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change From Baseline (Week 0) to Week 104 in Body Weight (kg)
Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)
Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure
Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in Total Cholesterol-ratio to Baseline
Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline
Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline
Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline
Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in Free Fatty Acids-ratio to Baseline
Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in Triglycerides-ratio to Baseline
Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline
Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in Glycated Haemoglobin (HbA1c) (Percent [%])
Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)
Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)
Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)
Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)
Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)
Change in fasting serum insulin from baseline (week 0) to week 104 measured in milli-international units per milliliter (mIU/mL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Percentage Change From Baseline (Week 0) to Week 52 in Body Weight
Percentage change in body weight from baseline (week 0) to week 52 is presented.
Change From Baseline (Week 0) to Week 52 in Body Weight (kg)
Change in body weight from baseline (week 0) to week 52 in kg is presented.
Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)
Change in BMI from baseline (week 0) to week 52 is presented.
Change From Baseline (Week 0) to Week 52 in Waist Circumference
Change in waist circumference from baseline (week 0) to week 52 is presented.
Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%
Number of participants who achieved >=5% weight loss at 52 weeks 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.
Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%
Number of participants who achieved >=10% weight loss at 52 weeks 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.
Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%
Number of participants who achieved >=15% weight loss at 52 weeks 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.
Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%
Number of participants who achieved >=20% weight loss at 52 weeks 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.
Number of Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any unfavourable 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 TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).
Number of Serious Adverse Events (SAEs)
A SAE was 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. The SAEs occurred from week 0 to week 111 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).
Change From Baseline (Week 0) to Week 104 in Pulse
Change in pulse from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Change From Baseline (Week 0) to Week 104 in Amylase
Change in amylase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Change From Baseline (Week 0) to Week 104 in Lipase
Change in lipase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Change From Baseline (Week 0) to Week 104 in Calcitonin
Change in calcitonin from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).

Full Information

First Posted
October 1, 2018
Last Updated
July 5, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03693430
Brief Title
Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Acronym
STEP 5
Official Title
Two-year Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2018 (Actual)
Primary Completion Date
January 29, 2021 (Actual)
Study Completion Date
March 23, 2021 (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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will look at the change in body weight from the start to the end of the study. Researchers will compare the weight loss in people taking semaglutide (a new medicine) to people taking "dummy" medicine. In addition to taking the medicine, participants will also have talks with study staff about healthy food choices, how the participant can be more physically active and what participants can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 2 years. The participants will have 19 clinic visits and 15 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
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semaglutide
Arm Type
Experimental
Arm Description
Participants will receive semaglutide 2.4 mg during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo (semaglutide) during 104-week treatment period in addition to a reduced-calorie diet and increased physical activity.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo (Semaglutide)
Intervention Description
S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
Primary Outcome Measure Information:
Title
Percentage Change From Baseline (Week 0) to Week 104 in Body Weight
Description
Percentage change in body weight for both in-trial and on-treatment observation period from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Time Frame
From Baseline (Week 0) to Week 104
Title
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%
Description
Number of participants who achieved greater than or equal to (>=) 5% weight loss at 104 weeks 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. The outcome measure was evaluated based on the data from both in-trial and on-treatment periods. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site. On-treatment observation period: the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Time Frame
At Week 104
Secondary Outcome Measure Information:
Title
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%
Description
Number of participants who achieved >=10% weight loss at 104 weeks 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 outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
At Week 104
Title
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%
Description
Number of participants who achieved >=15% weight loss at 104 weeks 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 outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
At Week 104
Title
Number of Participants Who Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%
Description
Number of participants who achieved >=20% weight loss at 104 weeks 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 outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
At Week 104
Title
Change From Baseline (Week 0) to Week 104 in Waist Circumference
Description
Change in waist circumference from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in Body Weight (kg)
Description
Change in body weight from baseline (week 0) to week 104 in kilogram (kg) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in Body Mass Index (BMI)
Description
Change in BMI from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in Systolic Blood Pressure
Description
Change in systolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in Diastolic Blood Pressure
Description
Change in diastolic blood pressure from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in Total Cholesterol-ratio to Baseline
Description
Change in total cholesterol from baseline (week 0) to week 104 measured in milligrams per deciliter (mg/dL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in High Density Lipoprotein (HDL) Cholesterol-ratio to Baseline
Description
Change in HDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in Low Density Lipoprotein (LDL) Cholesterol-ratio to Baseline
Description
Change in LDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in Very Low Density Lipoprotein (VLDL) Cholesterol-ratio to Baseline
Description
Change in VLDL cholesterol from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in Free Fatty Acids-ratio to Baseline
Description
Change in free fatty acids from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in Triglycerides-ratio to Baseline
Description
Change in triglycerides from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline
Description
Change in hsCRP from baseline (week 0) to week 104 measured in mg/dL is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in Glycated Haemoglobin (HbA1c) (Percent [%])
Description
Change in HbA1c from baseline (week 0) to week 104 in % is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in HbA1c (mmol/Mol)
Description
Change in HbA1c from baseline (week 0) to week 104 in millimole per mole (mmol/mol) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in Fasting Plasma Glucose (FPG) (mmol/L)
Description
Change in FPG from baseline (week 0) to week 104 in millimoles per liter (mmol/L) is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in FPG (mg/dL)
Description
Change in FPG from baseline (week 0) to week 104 in mg/dL is presented. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in Fasting Serum Insulin-ratio to Baseline (Pmol/L)
Description
Change in fasting serum insulin from baseline (week 0) to week 104 measured in picomole per liter (pmol) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Change in Fasting Serum Insulin-ratio to Baseline (mIU/mL)
Description
Change in fasting serum insulin from baseline (week 0) to week 104 measured in milli-international units per milliliter (mIU/mL) is presented as ratio to baseline. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: the uninterrupted time interval from randomisation to last contact with trial site.
Time Frame
From Baseline (Week 0) to Week 104
Title
Percentage Change From Baseline (Week 0) to Week 52 in Body Weight
Description
Percentage change in body weight from baseline (week 0) to week 52 is presented.
Time Frame
From Baseline (Week 0) to Week 52
Title
Change From Baseline (Week 0) to Week 52 in Body Weight (kg)
Description
Change in body weight from baseline (week 0) to week 52 in kg is presented.
Time Frame
From Baseline (Week 0) to Week 52
Title
Change From Baseline (Week 0) to Week 52 in Body Mass Index (BMI)
Description
Change in BMI from baseline (week 0) to week 52 is presented.
Time Frame
From Baseline (Week 0) to Week 52
Title
Change From Baseline (Week 0) to Week 52 in Waist Circumference
Description
Change in waist circumference from baseline (week 0) to week 52 is presented.
Time Frame
From Baseline (Week 0) to Week 52
Title
Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 5%
Description
Number of participants who achieved >=5% weight loss at 52 weeks 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.
Time Frame
At Week 52
Title
Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 10%
Description
Number of participants who achieved >=10% weight loss at 52 weeks 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.
Time Frame
At Week 52
Title
Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 15%
Description
Number of participants who achieved >=15% weight loss at 52 weeks 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.
Time Frame
At Week 52
Title
Number of Participants Who at 52 Weeks Achieved (Yes/no): Body Weight Reduction More Than or Equal to 20%
Description
Number of participants who achieved >=20% weight loss at 52 weeks 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.
Time Frame
At Week 52
Title
Number of Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was defined as any unfavourable 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 TEAE defined as an event that had onset date (or increase in severity) on or after the first day of exposure to treatment. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).
Time Frame
From Baseline (Week 0) to Week 111
Title
Number of Serious Adverse Events (SAEs)
Description
A SAE was 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. The SAEs occurred from week 0 to week 111 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 7 weeks of follow-up and excluding any period of temporary treatment interruption defined as >7 consecutive missed doses (corresponding to >7 weeks off-treatment).
Time Frame
From Baseline (Week 0) to Week 111
Title
Change From Baseline (Week 0) to Week 104 in Pulse
Description
Change in pulse from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in Amylase
Description
Change in amylase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in Lipase
Description
Change in lipase from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Time Frame
From Baseline (Week 0) to Week 104
Title
Change From Baseline (Week 0) to Week 104 in Calcitonin
Description
Change in calcitonin from baseline (week 0) to week 104 is presented. The outcome measure was evaluated based on the data from on-treatment observation period, which was defined as the interval from first to last trial product administration plus 2 weeks of follow-up and excluding any period of temporary treatment interruption defined as >2 consecutive missed doses (corresponding to >2 weeks off-treatment).
Time Frame
From Baseline (Week 0) to Week 104

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age more than or equal to 18 years at the time of signing informed consent Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease History of at least one self-reported unsuccessful dietary effort to lose body weight Exclusion criteria: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
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
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
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
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12203
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
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
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
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
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
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3Z 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 1V7
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
M4G 3E8
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
Budapest
ZIP/Postal Code
1132
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
H-1134
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Komarom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Szekszárd
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Alcorcón
ZIP/Postal Code
28922
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain

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
http://novonordisk-trials.com
Citations:
PubMed Identifier
32441473
Citation
Kushner RF, Calanna S, Davies M, Dicker D, Garvey WT, Goldman B, Lingvay I, Thomsen M, Wadden TA, Wharton S, Wilding JPH, Rubino D. Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5. Obesity (Silver Spring). 2020 Jun;28(6):1050-1061. doi: 10.1002/oby.22794.
Results Reference
background
PubMed Identifier
36655300
Citation
Wharton S, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Garvey WT. Two-year effect of semaglutide 2.4 mg on control of eating in adults with overweight/obesity: STEP 5. Obesity (Silver Spring). 2023 Mar;31(3):703-715. doi: 10.1002/oby.23673. Epub 2023 Jan 18.
Results Reference
background
PubMed Identifier
36216945
Citation
Garvey WT, Batterham RL, Bhatta M, Buscemi S, Christensen LN, Frias JP, Jodar E, Kandler K, Rigas G, Wadden TA, Wharton S; STEP 5 Study Group. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022 Oct;28(10):2083-2091. doi: 10.1038/s41591-022-02026-4. Epub 2022 Oct 10.
Results Reference
derived

Learn more about this trial

Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

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