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Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Univ of Alabama Birmingham
Birmingham, Alabama, United States
Velocity Clin Res Los Angeles
Los Angeles, California, United States
The Chappel Group Research
Kissimmee, Florida, United States
Clinical Trial Res Assoc,Inc
Plantation, Florida, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
Accellacare
Wilmington, North Carolina, United States
The University of Penn Center
Philadelphia, Pennsylvania, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Start Date
September 13, 2021
Primary Completion Date
March 24, 2023
Completion Date
May 12, 2023
Last Updated
December 4, 2025
667
ACTUAL participants
Oral semaglutide
DRUG
Placebo (semaglutide)
DRUG
Lead Sponsor
Novo Nordisk A/S
NCT07472881
NCT01143454
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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