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Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)

NCT05035095 · Completed

Last updated 2026-05-28

This clinical trial is testing how well a daily semaglutide tablet works to help people who are overweight or living with obesity manage their weight.

Status Completed The study has finished.
Phase Phase 3 Confirms effectiveness in a large group before approval.
Type Interventional (clinical trial)
Design Randomized, quadruple-blind treatment study
Participants 667 people
Who can join Ages 18+ · all sexes
Timeline Started 2021-09 · est. completion 2023-05
Where 56 sites · Canada, Denmark, Finland, France, Germany, Japan, Poland, Russia, United States

What this study is testing ClinicalTrials.gov NCT05035095 ↗

Description as written by the study sponsor.

This study is being conducted 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 doctor. Blood samples will be taken at 10 visits. Participants will have a test to check their heart done at 3 visits. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. If participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.

Treatments tested

Main thing measuredPercentage Change in Body Weight
SponsorNovo Nordisk A/S
Conditions studiedObesity, Overweight
GLP-1 drugs semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05035095 ↗