Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 1,961
- Locations
- 1
- Primary Endpoint
- Change in Body Weight (%)
Overview
Brief Summary
This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, 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 has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.
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
- •Main phase:
- •Male or female, age greater than or equal to 18 years at the time of signing informed consent
- •Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 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
- •Extension phase:
- •Informed consent for the extension phase obtained before any trial related activities for the extension phase
- •On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo
Exclusion Criteria
- •Main phase:
- •Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
- •A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •Extension phase:
- •Female who is pregnant or intends to become pregnant during the extension phase
- •Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial
Arms & Interventions
Semaglutide s.c. 2.4 mg once weekly
Participants will receive semaglutide for 68 weeks.
Intervention: Semaglutide (Drug)
Semaglutide placebo
Participants will receive semaglutide matching placebo for 68 weeks.
Intervention: Placebo (semaglutide) (Drug)
Outcomes
Primary Outcomes
Change in Body Weight (%)
Time Frame: Baseline (week 0) to week 68
Change in body weight from baseline (week 0) 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 date of randomization (week 0) to date of last contact with trial site (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).
Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)
Time Frame: After week 68
Number of participants who achieved weight loss more than or equal to 5% (yes/no) at week 68 are 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 randomization (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.
Secondary Outcomes
- Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)(Week 68)
- Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)(Week 68)
- Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)(Week 68)
- Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score(Baseline (week 0) to week 68)
- Change in HbA1C (mmol/Mol)(Baseline (week 0) to week 68)
- Change in Free Fatty Acids (mg/dL) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Waist Circumference (cm)(Baseline (week 0) to week 68)
- Change in Systolic Blood Pressure (mmHg)(Baseline (week 0) to week 68)
- Change in Short Form 36 (SF-36)(Baseline (week 0) to week 68)
- Change in Body Weight (kg)(Baseline (week 0) to week 68)
- Change in Body Mass Index (BMI) (kg/m2)(Baseline (week 0) to week 68)
- Change in HbA1C (%)(Baseline (week 0) to week 68)
- Change in Fasting Plasma Glucose (FPG) (mg/dL)(Baseline (week 0) to week 68)
- Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Diastolic Blood Pressure (mmHg)(Baseline (week 0) to week 68)
- Change in Total Cholesterol (mg/dL) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Body Composition (Total Fat Mass) (%)(Baseline (week 0) to week 68)
- Change in Triglycerides (mg/dL) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Leptin (ng/mL) - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Body Composition (Total Fat Mass) (kg)(Baseline (week 0) to week 68)
- Change in Body Composition (Lean Body Mass) (%)(Baseline (week 0) to week 68)
- Change in Body Composition (Lean Body Mass) (kg)(Baseline (week 0) to week 68)
- Number of Treatment Emergent Adverse Events (TEAEs)(Baseline (week 0) to week 75)
- Change in Pulse(Baseline (week 0) to week 68)
- Change in Body Composition (Visceral Fat Mass) (%)(Baseline (week 0) to week 68)
- Change in Body Weight (kg) - DEXA Subpopulation(Baseline (week 0) to week 68)
- Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score(After week 68)
- Number of Serious Adverse Events (SAEs)(Baseline (week 0) to week 75)
- Change in Amylase - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Lipase - Ratio to Baseline(Baseline (week 0) to week 68)
- Change in Body Composition (Visceral Fat Mass) (kg)(Baseline (week 0) to week 68)
- Change in Body Weight (%) - DEXA Subpopulation(Baseline (week 0) to week 68)
- Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score(After week 68)
- Change in Calcitonin - Ratio to Baseline(Baseline (week 0) to week 68)