Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity

Sponsor
Novo Nordisk A/S
Study ID
NCT04998136
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide 2.4 mg — DRUG
    Administered subcutaneously (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 44 weeks. Doses gradually increased to 2.4 mg
  • Placebo (semaglutide 2.4 mg) — DRUG
    Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks

Study Details

This study looks at how well semaglutide helps people lose weight. This study will look at the change in the participants' body weight from the start to the end of the study. The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo. Placebo is a "dummy" medicine that looks like the study medicine, but has no effect on the body. 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. Participants will also have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. The study will last for about a year (50 weeks). Participants will have 10 clinic visits and 8 phone calls. At 6 of the clinic visits participants will have blood samples taken. Participants cannot take part if participants have or have had diabetes. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Key Dates

Start date
Aug 15, 2022
Status verified
Dec 2025
Primary completion
Oct 16, 2023
Completion
Nov 20, 2023

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide 2.4 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Body Weight (%) : In-trial Observation Period [ Time Frame: Baseline (week 0), end of treatment (week 44) ]

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