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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT05035095

Public ClinicalTrials.gov record NCT05035095. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 11:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT05035095
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novo Nordisk A/S
Industry
Enrollment
667 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 12, 2021
Primary completion
Mar 23, 2023
Completion
May 11, 2023
Last update posted
May 6, 2026

2021 – 2023

United States locations

U.S. sites
13
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
Univ of Alabama Birmingham Birmingham Alabama 35233
Velocity Clin Res Los Angeles Los Angeles California 90017
The Chappel Group Research Kissimmee Florida 34744
Clinical Trial Res Assoc,Inc Plantation Florida 33324
East West Med Res Inst Honolulu Hawaii 96814
Midwest Inst For Clin Res Indianapolis Indiana 46260
Rochester Clinical Research, Inc. Rochester New York 14609
Accellacare Wilmington North Carolina 28401
The University of Penn Center Philadelphia Pennsylvania 19104-3317
Velocity Clinical Res-Dallas Dallas Texas 75230
Washington Cntr Weight Mgmt Arlington Virginia 22206
Selma Medical Associates Winchester Virginia 22601-3834
Capital Clin Res Ctr,LLC Olympia Washington 98502

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05035095, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2026 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05035095 live on ClinicalTrials.gov.

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