Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
Completed · Phase 3 · Has a placebo group
Conditions studied: Obesity, Overweight
In brief
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.
Key facts
- Study ID
- NCT05035095
- Run by
- Novo Nordisk A/S
- People needed
- 667
- Starts
- 2021-09-13
- Expected to finish
- 2023-05-12
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Body mass index (BMI):
- greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease OR greater than or equal to 30.0 kg/m\^2
- History of at least one self-reported unsuccessful dietary effort to lose body weight
You may not qualify if…
- HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening
- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Where it is running
- 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
- Washington Cntr Weight Mgmt — Arlington, Virginia, United States
- Selma Medical Associates — Winchester, Virginia, United States
- Capital Clin Res Ctr,LLC — Olympia, Washington, United States
- Ocean West Research Clinic — Surrey, British Columbia, Canada
- G.A. Research Associates Ltd. — Moncton, New Brunswick, Canada
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada
- Wharton Medical Clinic Clinical Trials (Hamilton) — Hamilton, Ontario, Canada
- Premier Clinical Trial Research Network (PCTRN) — Hamilton, Ontario, Canada
- Sjællands Universitetshospital, Køge - Medicinsk Afdeling — Køge, Region Sjælland, Denmark
- Gentofte Hospital - Center for Klinisk Metabolisk Forskning — Hellerup, Denmark
- Hvidovre Hospital Endokrinologisk forsknings afsnit 159 — Hvidovre, Denmark
- Slagelse Sygehus Ambulatorium for hjertesygdomme — Slagelse, Denmark
- Obesity Research Unit — Helsinki, Finland
- StudyCor — Jyväskylä, Finland
- Seinäjoen keskussairaala — Seinäjoki, Finland
- Univ of Alabama Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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