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Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
Sponsor: Novo Nordisk A/S
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.
Official title: Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
667
Start Date
2021-09-13
Completion Date
2023-05-12
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
Oral semaglutide
Participants will receive a daily dose of oral semaglutide.
Placebo (semaglutide)
Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.
Locations (56)
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
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
Les Hopitaux de Chartres-Hopital Louis Pasteur
Le Coudray, France
Fondation Hôtel-Dieu
Le Creusot, France
Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2
Le Creusot, France
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
Pessac, France
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
Saint-Herblain, France
Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2
Toulouse, France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, France
InnoDiab Forschung GmbH
Essen, Germany
Praxis Dr. med. M. Esser
Essen, Germany
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, Germany
Dr. Milek medikum
Hohenmölsen, Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, Germany
Praxis Dr. med. Wenzl-Bauer
Rehlingen-Siersburg, Germany
MZM Praxis Drs. Erlinger
Stuttgart, Germany
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, Germany
Chiba University Hospital_Diabetes, Metabolism and Endocrinology
Chiba-shi, Chiba, Japan
Suidoubashi Medical Clinic_Internal Medicine
Chiyoda-ku, Tokyo, Japan
Higashi-shinjuku clinic
Tokyo, Japan
NZOZ Przychodnia Specjalistyczna Medica
Lublin, Lubelski, Poland
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
Bialystok, Podlaskie Voivodeship, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, Pomeranian Voivodeship, Poland
Centrum Zdrowia Metabolicznego Paweł Bogdański
Poznan, Wielkopolskie Voivodeship, Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, Poland
Tumen State Medical University
Tyumen, Russia, Russia
LLC "Clinic of new technologies in Medicine"
Dzerzhinskiy, Russia
FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia
Moscow, Russia
Endocrinological Dispensary of Department of healthcare ser.
Moscow, Russia
Federal Bureau for Medical and Social Expertise
Moscow, Russia
Joint Stock Company "Polyclinic Complex"
Saint Petersburg, Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, Russia
Joint Stock Company "Medical technologies"
Yekaterinburg, Russia