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Semaglutide

Ozempic, Rybelsus, Wegovy

Quick Stats
Studies 78
Trials 100
Completed PHASE3 INTERVENTIONAL NCT05035095

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: Oral semaglutide
Type: DRUG
Description: Participants will receive a daily dose of oral semaglutide.
Name: Placebo (semaglutide)
Type: DRUG
Description: Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.

Primary Outcomes

Measure: Relative change in body weight
TimeFrame: From baseline (week 0) to end of treatment (week 68)
Description: percentage-point
Measure: Achievement of body weight reduction greater than or equal to 5% (Yes/No)
TimeFrame: At end-of-treatment (week 68)
Description: Count of participants

Trial Information

NCT ID

NCT05035095

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Novo Nordisk A/S

Last Updated

December 15, 2025