Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity Who Have Reached Target Dose During run-in Period
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 902
- Locations
- 1
- Primary Endpoint
- Change From Randomisation to Week 68 in Body Weight (%)
Overview
Brief Summary
This study will look at the change in participant's 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, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight.
The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The 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 1.5 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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 greater than or equal to 18 years at the time of signing informed consent
- •Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27 kg/sqm 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
- •Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by 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
Arms & Interventions
Semaglutide
Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.
Maintenance period: Participants will be randomized to receive semaglutide injection for 48 weeks (from week 20 to week 68).
The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.
Intervention: Semaglutide (Drug)
Placebo
Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.
Maintenance period: Participants will be randomized to receive semaglutide placebo injection for 48 weeks (from week 20 to week 68).
The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.
Intervention: Semaglutide (Drug)
Placebo
Run-in Period: Participants will receive semaglutide at an escalating doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg) for 20 weeks (week 0 to week 20). The dose will be escalated to next level every 4 weeks.
Maintenance period: Participants will be randomized to receive semaglutide placebo injection for 48 weeks (from week 20 to week 68).
The trial product will be administered as an adjunct to a reduced-calorie diet and increased physical activity during the trial period.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Randomisation to Week 68 in Body Weight (%)
Time Frame: Randomisation (week 20) to week 68
Change in body weight from baseline (week 20) to week 68 is presented. The endpoint was evaluated based on the data from both in-trial and on-treatment observation periods. In-trial observation period: the uninterrupted time interval from start of run-in (week 0) to last trial-related subject-site contact (week 75). On-treatment observation period: includes all time intervals in which participants are considered to be on treatment from the first (week 0) to last trial product administration (week 68) including 2 weeks of follow-up. It excludes any period of temporary treatment interruption. Temporary treatment interruption is defined as more than 2 consecutive missed doses (off-treatment period).
Secondary Outcomes
- Change in Diastolic Blood Pressure(Randomization (week 20) to week 68)
- Change in Waist Circumference(Randomization (week 20) to week 68)
- Change in Body Weight [Kilogram (Kg)](Randomisation (week 20) to week 68)
- Change in Body Mass Index (BMI)(Randomization (week 20) to week 68)
- Change in Fasting Serum Insulin(Randomization (week 20) to week 68)
- Change in High-density Lipoproteins (HDL)(Randomization (week 20) to week 68)
- Change in Low-density Lipoproteins (LDL)(Randomization (week 20) to week 68)
- Change in Triglycerides(Randomization (week 20) to week 68)
- Change in Fasting Plasma Glucose [Millimoles Per Litre (mmol/L)](Randomization (week 20) to week 68)
- Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 5%(Run-in (week 0) to week 68)
- Change in Physical Functioning Score (Short Form 36 [SF-36])(Randomization (week 20) to week 68)
- Change in Free Fatty Acids(Randomization (week 20) to week 68)
- Subjects Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score(Randomisation (week 20) to week 68)
- Subjects Who Achieve (Yes/no): Body Weight Reduction < 0%(Run-in (week 0) to week 68)
- Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 15%(Run-in (week 0) to week 68)
- Change in Systolic Blood Pressure(Randomization (week 20) to week 68)
- Change in HbA1c [Millimoles Per Mole (mmol/Mol)](Randomization (week 20) to week 68)
- Change in Total Cholesterol(Randomization (week 20) to week 68)
- Change in Very Low-density Lipoproteins (VLDL)(Randomization (week 20) to week 68)
- Change in Body Weight(Run-in (week 0) to week 68)
- Change in Haemoglobin A1c (HbA1c) [%](Randomization (week 20) to week 68)
- Change in Fasting Plasma Glucose [Milligrams Per Deciliter (mg/dL)](Randomization (week 20) to week 68)
- Number of Treatment-emergent AEs(Randomisation (week 20) to week 75)
- Change in Amylase(Randomisation (week 20) to week 68)
- Subjects Who Gain Weight (Yes/no)(Randomisation (week 20) to week 68)
- Subjects Who Achieve (Yes/no): Body Weight Reduction ≥ 10%(Run-in (week 0) to week 68)
- Number of Treatment-emergent Adverse Events (AEs)(Run-in (week 0) to randomisation (week 20))
- Number of Serious Adverse Events (SAEs)(Randomisation (week 20) to week 75)
- Change in Pulse(Randomisation (week 20) to week 68)
- Change in Lipase(Randomisation (week 20) to week 68)
- Change in Calcitonin(Randomisation (week 20) to week 68)