Research Study to Investigate How Well Semaglutide Works Compared to Liraglutide in People Living With Overweight or Obesity

Conditions

• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  Dose gradually increased to 2.4 mg administered once weekly for 68 weeks
• Placebo (semaglutide) — DRUG
  Administered once weekly for 68 weeks
• Liraglutide — DRUG
  Dose gradually increased to 3.0 mg administered once daily for 68 weeks
• Placebo (liraglutide) — DRUG
  Administered once daily for 68 weeks

Study Details

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.

Key Dates

Start date

Sep 11, 2019

Status verified

May 2023

Primary completion

Mar 27, 2021

Completion

May 11, 2021

Study Design

Enrollment

338 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide
  Semaglutide administered s.c. (subcutaneously, under the skin) adjunct to a reduced-calorie diet and increased physical activity
• Placebo Comparator: Placebo (semaglutide)
  Placebo (semaglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity
• Active Comparator: Liraglutide
  Liraglutide administered s.c. adjunct to a reduced-calorie diet and increased physical activity
• Placebo Comparator: Placebo (liraglutide)
  Placebo (liraglutide) administered s.c. adjunct to a reduced-calorie diet and increased physical activity

Primary Outcome Measure

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 ]

Locations (19)

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