Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
NCT ID: NCT05035095
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
667 participants
INTERVENTIONAL
2021-09-13
2023-05-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Oral semaglutide
Participants will receive once daily semaglutide tables in a dose escalating manner for 68 weeks: 3 mg (week 1-4), 7 mg (week 5-8), 14 mg (week 9-12), 25 mg (week 13-16) and 50 mg (week 17-68)
Oral semaglutide
Participants will receive a daily dose of oral semaglutide.
Oral semaglutide placebo
All participants are given once daily dose for 68 weeks
Placebo (semaglutide)
Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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 Med Clin Trials
Hamilton, Ontario, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Center for Klinisk Metabolisk Forskning
Hellerup, , Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, , Denmark
Sjællands Universitetshospital, Køge - Medicinsk Afdeling
Køge, , 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-1
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
Milek, Hohenmölsen
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
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
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
Countries
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References
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Knop FK, Aroda VR, do Vale RD, Holst-Hansen T, Laursen PN, Rosenstock J, Rubino DM, Garvey WT; OASIS 1 Investigators. Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 26;402(10403):705-719. doi: 10.1016/S0140-6736(23)01185-6. Epub 2023 Jun 26.
Other Identifiers
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U1111-1253-1670
Identifier Type: OTHER
Identifier Source: secondary_id
2020-002953-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN9932-4737
Identifier Type: -
Identifier Source: org_study_id
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