NCT05035095

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 667 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Overweight

Interventions

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

Timeline

• Start date: 2021-09-13
• Primary completion: 2023-03-24
• Completion: 2023-05-12
• First posted: 2021-09-05
• Last updated: 2025-12-04

Locations

56 sites across 9 countries: United States, Canada, Denmark, Finland, France, Germany, Japan, Poland, Russia

Regulatory

• FDA-regulated drug study