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
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 338
- Locations
- 1
- Primary Endpoint
- Change From Baseline (Week 0) to Week 68 in Body Weight (%) (Semaglutide 2.4 mg Versus Liraglutide 3.0 mg)
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Semaglutide once weekly vs liraglutide once daily treatment will be open label, but each of the two active treatment arms will be double blinded against placebo administered at the same dosing frequency.
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Semaglutide
Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity
Intervention: Semaglutide (Drug)
Placebo (semaglutide)
Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Intervention: Placebo (semaglutide) (Drug)
Liraglutide
Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Intervention: Liraglutide (Drug)
Placebo (liraglutide)
Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
Intervention: Placebo (liraglutide) (Drug)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- 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)(Baseline (week 0), week 68)
- Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction Greater Than or Equal to (>=) 10% (Yes/no)(From baseline (week 0) to week 68)
- Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=15% (Yes/no)(From baseline (week 0) to week 68)
- Number of Participants Who From Baseline (Week 0) to Week 68 Achieved Body Weight Reduction >=20% (Yes/no)(From baseline (week 0) to week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mg/dL) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mmol/L) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mg/dL) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Waist Circumference(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Milligram Per Deciliter (mg/dL)) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: Total Cholesterol (Millimoles Per Liter (mmol/L)) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mg/dL) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in High-sensitivity C-reactive Protein (Hs-CRP): Ratio to Baseline(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (%)(Baseline (week 0), week 68)
- Number of Participants Who From Baseline (Week 0) to Week 68 Permanently Discontinued Randomized Trial Product(From baseline (week 0) to week 68)
- Change From Baseline (Week 0) to Week 68 in Body Weight (Kilograms (kg))(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: High Density Lipoprotein (HDL) Cholesterol (mmol/L) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: Free Fatty Acids (FFA) (mg/dL) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Milli-international Units Per Liter (mIU/L)): Ratio to Baseline(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Systolic Blood Pressure(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Diastolic Blood Pressure(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: Low Density Lipoprotein (LDL) Cholesterol (mmol/L) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Fasting Serum Insulin (Picomoles Per Liter (Pmol/L)): Ratio to Baseline(Baseline (week 0), week 68)
- Number of Participants at Baseline (Week 0) and Week 68 in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes (T2D))(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Glycated Haemoglobin (HbA1c) (Millimoles Per Mole (mmol/Mol))(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mmol/L)(Baseline (week 0), week 68)
- Number of Treatment Emergent Adverse Events (TEAEs) From Baseline (Week 0) to Week 75(From baseline (week 0) to week 75)
- Number of Serious Adverse Events (SAEs) From Baseline (Week 0) to Week 75(From baseline (week 0) to week 75)
- Change From Baseline (Week 0) to Week 68 in Lipids: Triglycerides (mmol/L) (Ratio to Baseline)(Baseline (week 0), week 68)
- Change From Baseline (Week 0) to Week 68 in Fasting Plasma Glucose (mg/dL)(Baseline (week 0), week 68)