CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 667 enrolled
Drug / intervention
Oral semaglutide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05035095
NCT05035095Phase 3Completed

Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)

Novo Nordisk A/S·interventional·Posted Sep 5, 2021·Updated May 7, 2026

In Brief

A Phase 3 clinical trial evaluating Oral semaglutide and Placebo (semaglutide) for Obesity and Overweight. Completed, enrolled 667 participants across 56 sites in 9 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Overweight
CountriesCanada, Denmark, Finland, France, Germany, Japan, Poland, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedSep 5, 2021
Enrollment StartSep 13, 2021
Primary CompletionMar 24, 2023
Study CompletionMay 12, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.8 years ago

Interventions

Oral semaglutidedrug

Participants will receive a daily dose of oral semaglutide.

Placebo (semaglutide)drug

Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.