Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in East Asian People Who Are Overweight or Living With Obesity

Sponsor
Novo Nordisk A/S
Study ID
NCT05132088
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • semaglutide 50 mg — DRUG
    Participants will have semaglutide for 68 weeks and will have 1 tablet every morning. Dose gradually increased to 50 mg.
  • placebo (semaglutide) — DRUG
    Participants will have placebo tablets for 68 weeks and will have 1 tablet every morning.

Study Details

Novo Nordisk are doing this study to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. This study will look at the change in participants' body weight. Participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). For a fair comparison, people are divided into two groups at random by a computer. This process is called randomisation. Semaglutide tablets are new medicine being tested to treat overweight and obesity. Doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. Participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning. In addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight The study will last for about 1½ year. Participants will have 14 clinic visits and 7 phone calls with the study healthcare professional. Blood samples will be taken at 12 visits. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period. If participants are a woman and are able to become pregnant, participants will be checked for pregnancy via urine tests.

Key Dates

Start date
Nov 16, 2021
Status verified
Jun 2025
Primary completion
Jul 11, 2023
Completion
Sep 1, 2023

Study Design

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

Arms

  • Experimental: oral semaglutide 50 mg once daily
    All participants will get semaglutide or placebo tablets, 1 tablet every morning.
  • Placebo Comparator: oral semaglutide placebo once daily
    All participants will get semaglutide or placebo tablets, 1 tablet every morning.

Primary Outcome Measure

Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]

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