- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04074161
Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity (STEP 8)
May 18, 2023 updated by: Novo Nordisk A/S
Effect and Safety of Subcutaneous Semaglutide 2.4 mg Once Weekly Compared to Liraglutide 3.0 mg Once Daily on Weight Management in Subjects With Overweight or Obesity
This study will look at participants' body weight from the start to the end of the study.
The study will last for about 1½ years.
This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day.
Participants will either get semaglutide, liraglutide or "dummy" medicine.
Which treatment is decided by chance.
Participants who receive semaglutide or semaglutide "dummy" medicine will need to take 1 injection once a week.
Participants who receive liraglutide or liraglutide "dummy" medicine will need to take 1 injection once daily.
The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.
During the study participants will have talks with study staff about eating healthy food and how to be more physically active.
Participants will have 16 clinic visits and 7 phone calls with the study doctor.
At 4 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit.
Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
338
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- Novo Nordisk INvestigational Site
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California
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Fullerton, California, United States, 92835
- Novo Nordisk INvestigational Site
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Huntington Beach, California, United States, 92648
- Novo Nordisk INvestigational Site
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Florida
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Jacksonville, Florida, United States, 32205
- Novo Nordisk INvestigational Site
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Plantation, Florida, United States, 33324
- Novo Nordisk INvestigational Site
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Hawaii
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Honolulu, Hawaii, United States, 96814
- Novo Nordisk INvestigational Site
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Illinois
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Evanston, Illinois, United States, 60201-2477
- Novo Nordisk INvestigational Site
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Indiana
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Indianapolis, Indiana, United States, 46260
- Novo Nordisk INvestigational Site
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Novo Nordisk INvestigational Site
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New York
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Albany, New York, United States, 12203
- Novo Nordisk INvestigational Site
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North Carolina
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Wilmington, North Carolina, United States, 28401
- Novo Nordisk INvestigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-3317
- Novo Nordisk INvestigational Site
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South Carolina
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Charleston, South Carolina, United States, 29425
- Novo Nordisk INvestigational Site
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Texas
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Dallas, Texas, United States, 75230
- Novo Nordisk INvestigational Site
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Dallas, Texas, United States, 75226
- Novo Nordisk INvestigational Site
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Rockwall, Texas, United States, 75032
- Novo Nordisk INvestigational Site
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Virginia
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Arlington, Virginia, United States, 22206
- Novo Nordisk INvestigational Site
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Winchester, Virginia, United States, 22601-3834
- Novo Nordisk INvestigational Site
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Washington
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Olympia, Washington, United States, 98502
- Novo Nordisk INvestigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female, age 18 years or older at the time of signing informed consent
- Body mass index (BMI) equal to or above 30.0 kg/m^2 or equal to or above 27.0 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 equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- History of type 1 or type 2 diabetes mellitus
- A self-reported change in body weight of more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Semaglutide
Semaglutide administered s.c.
(subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity
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Dose gradually increased to 2.4 mg administered once weekly for 68 weeks
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Placebo Comparator: Placebo (semaglutide)
Placebo (semaglutide) administered s.c.
adjunct to a reduced-calorie diet and increased physical activity
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Administered once weekly for 68 weeks
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Active Comparator: Liraglutide
Liraglutide administered s.c.
adjunct to a reduced-calorie diet and increased physical activity
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Dose gradually increased to 3.0 mg administered once daily for 68 weeks
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Placebo Comparator: Placebo (liraglutide)
Placebo (liraglutide) administered s.c.
adjunct to a reduced-calorie diet and increased physical activity
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Administered once daily for 68 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in body weight (%) is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)
Time Frame: From baseline (week 0) to week 68
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Number of participants who achieved >= 10% weight reduction from baseline (week 0) to week 68 is presented.
In the reported data, 'Yes' infers the number of participants who have achieved >= 10% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 10% weight reduction.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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From baseline (week 0) to week 68
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Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)
Time Frame: From baseline (week 0) to week 68
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Number of participants who achieved >= 15% weight reduction from baseline (week 0) to week 68 is presented.
In the reported data, 'Yes' infers the number of participants who have achieved >= 15% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 15% weight reduction.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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From baseline (week 0) to week 68
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Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)
Time Frame: From baseline (week 0) to week 68
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Number of participants who achieved >= 20% weight reduction from baseline (week 0) to week 68 is presented.
In the reported data, 'Yes' infers the number of participants who have achieved >= 20% weight reduction, whereas 'No' infers the number of participants who did not achieve >= 20% weight reduction.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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From baseline (week 0) to week 68
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Change From Baseline (Week 0) to Week 68 in Waist Circumference
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in waist circumference is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in body weight is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Pooled Placebo and Liraglutide 3.0 mg Versus Pooled Placebo)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in body weight (%) is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in systolic blood pressure is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in diastolic blood pressure is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in total cholesterol (measured in mg/dL) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in total cholesterol (measured in mmol/L) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mg/dL) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in HDL cholesterol (measured in mmol/L) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mg/dL) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in LDL cholesterol (measured in mmol/L) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mg/dL) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in VLDL cholesterol (measured in mmol/L) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in FFA (measured in mg/dL) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in FFA (measured in mmol/L) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in triglycerides (measured in mg/dL) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in triglycerides (measured in mmol/L) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in hs-CRP (measured in mg/L) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in HbA1c (%) is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in HbA1c is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in fasting plasma glucose is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in fasting plasma glucose is presented.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in fasting serum insulin (measured in mIU/L) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline
Time Frame: Baseline (week 0), week 68
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Change from baseline (week 0) to week 68 in fasting serum insulin (measured in pmol/L) is presented as ratio to baseline.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))
Time Frame: Baseline (week 0), week 68
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Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and 68 are presented.
These categories were set as per the following criteria: 1) Normo-glycaemia: fasting plasma glucose (FPG) less than (<) 5.6 mmol/L (<100 mg/dL) and/or glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: FPG 5.6 - 6.9 mmol/L (both inclusive), FPG 100 - 125 mg/dL (both inclusive) or HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: FPG greater than or equal to (>=) 7.0 mmol/L (>=126 mg/dL) and/or HbA1c >=6.5%.
Data is reported for 'in-trial' period: the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Baseline (week 0), week 68
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Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product
Time Frame: From baseline (week 0) to week 68
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Number of participants who from baseline (week 0) to week 68 permanently discontinued randomized trial product are presented.
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From baseline (week 0) to week 68
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Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75
Time Frame: From baseline (week 0) to week 75
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An adverse event (AE) was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
All AEs mentioned here are TEAEs defined as AEs, with the onset of the event occurred in the on-treatment period.
A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.
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From baseline (week 0) to week 75
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Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75
Time Frame: From baseline (week 0) to week 75
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An AE was any untoward medical occurrence in a clinical trial participant that was temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
An SAE was defined as an AE that 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 is a congenital anomaly/birth defect.
SAEs occurred based on the on-treatment period is presented.
A time-point was considered on treatment if any dose of trial product has been administrated within the prior 49 days.
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From baseline (week 0) to week 75
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Reporting Anchor and Disclosure (1452), Novo Nordisk A/S
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wharton S, Davies M, Dicker D, Lingvay I, Mosenzon O, Rubino DM, Pedersen SD. Managing the gastrointestinal side effects of GLP-1 receptor agonists in obesity: recommendations for clinical practice. Postgrad Med. 2022 Jan;134(1):14-19. doi: 10.1080/00325481.2021.2002616. Epub 2021 Nov 29.
- Rubino DM, Greenway FL, Khalid U, O'Neil PM, Rosenstock J, Sorrig R, Wadden TA, Wizert A, Garvey WT; STEP 8 Investigators. Effect of Weekly Subcutaneous Semaglutide vs Daily Liraglutide on Body Weight in Adults With Overweight or Obesity Without Diabetes: The STEP 8 Randomized Clinical Trial. JAMA. 2022 Jan 11;327(2):138-150. doi: 10.1001/jama.2021.23619.
- Snitker S, Egebjerg C, Frederiksen M, Sparre T. Ease-of-use and acceptability of the novel semaglutide 2.4 mg single-dose pen-injector in people with overweight or obesity in the STEP 8 phase III trial. Diabetes Obes Metab. 2022 Nov;24(11):2273-2276. doi: 10.1111/dom.14809. Epub 2022 Aug 7. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 11, 2019
Primary Completion (Actual)
March 27, 2021
Study Completion (Actual)
May 11, 2021
Study Registration Dates
First Submitted
August 28, 2019
First Submitted That Met QC Criteria
August 28, 2019
First Posted (Actual)
August 29, 2019
Study Record Updates
Last Update Posted (Actual)
May 19, 2023
Last Update Submitted That Met QC Criteria
May 18, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9536-4576
- U1111-1233-0977 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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