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

Last updated: July 5, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Hypertriglyceridemia

Diabetes Prevention

Treatment

Oral semaglutide

Placebo (semaglutide)

Clinical Study ID

NCT05035095
NN9932-4737
2020-002953-11
U1111-1253-1670
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, age greater than or equal to 18 years at the time of signinginformed 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 bodyweight

Exclusion

Exclusion Criteria:

  • HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the centrallaboratory at screening

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 daysbefore screening irrespective of medical records

Study Design

Total Participants: 667
Treatment Group(s): 2
Primary Treatment: Oral semaglutide
Phase: 3
Study Start date:
September 13, 2021
Estimated Completion Date:
May 12, 2023

Connect with a study center

  • Novo Nordisk Investigational Site

    Surrey, British Columbia V3Z 2N6
    Canada

    Site Not Available

  • Ocean West Research Clinic

    Surrey, British Columbia V3Z 2N6
    Canada

    Site Not Available

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick E1G 1A7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Moncton, New Brunswick E1G 1A7
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Hamilton Med Res Group

    Hamilton, Ontario L8M 1K7
    Canada

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Wharton Med Clin Trials

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Center for Klinisk Metabolisk Forskning

    Hellerup, 2900
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Hellerup, 2900
    Denmark

    Site Not Available

  • Hvidovre Hospital Endokrinologisk forsknings afsnit 159

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Køge, 4600
    Denmark

    Site Not Available

  • Sjællands Universitetshospital

    Køge, 4600
    Denmark

    Site Not Available

  • Novo Nordisk Investigational Site

    Slagelse, 4200
    Denmark

    Site Not Available

  • Obesity Research Unit

    Helsinki, 00014
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Jyväskylä, 40620
    Finland

    Site Not Available

  • StudyCor

    Jyväskylä, 40620
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    Seinäjoki, 60220
    Finland

    Site Not Available

  • Seinäjoen keskussairaala

    Seinäjoki, 60220
    Finland

    Site Not Available

  • Novo Nordisk Investigational Site

    University Of Helsinki, 00014
    Finland

    Site Not Available

  • Les Hopitaux de Chartres-Hopital Louis Pasteur

    Le Coudray, 28630
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Le Coudray, 28630
    France

    Site Not Available

  • Fondation Hôtel-Dieu

    Le Creusot, 71200
    France

    Site Not Available

  • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2

    Le Creusot, 71200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Le Creusot, 71200
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2

    Pessac, 33600
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Pessac, 33600
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1

    Saint Herblain, 44800
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Herblain, 44800
    France

    Site Not Available

  • Centre de Recherche Clinique Portes Du Sud

    Venissieux, 69200
    France

    Site Not Available

  • Groupe Hospitalier Mutualiste Des Portes Du Sud

    Venissieux, 69200
    France

    Site Not Available

  • Novo Nordisk Investigational Site

    Venissieux, 69200
    France

    Site Not Available

  • InnoDiab Forschung GmbH

    Essen, 45136
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Essen, 45136
    Germany

    Site Not Available

  • Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR

    Hamburg, 22041
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hamburg, 22041
    Germany

    Site Not Available

  • Milek, Hohenmölsen

    Hohenmölsen, 06679
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Hohenmölsen, 06679
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Oldenburg I. Holst, 23758
    Germany

    Site Not Available

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Praxis Dr. med. Wenzl-Bauer

    Rehlingen-Siersburg, 66780
    Germany

    Site Not Available

  • Erlinger

    Stuttgart, 70378
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Stuttgart, 70378
    Germany

    Site Not Available

  • Novo Nordisk Investigational Site

    Wangen, 88239
    Germany

    Site Not Available

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239
    Germany

    Site Not Available

  • Chiba University Hospital_Diabetes, Metabolism and Endocrinology

    Chiba-shi, Chiba, 260-8677
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Chiba-shi, Chiba, 260-8677
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Chiyoda-ku, Tokyo, 101-0065
    Japan

    Site Not Available

  • Suidoubashi Medical Clinic

    Chiyoda-ku, Tokyo, 101-0065
    Japan

    Site Not Available

  • Higashi-shinjuku clinic

    Tokyo, 169-0072
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tokyo, 169-0072
    Japan

    Site Not Available

  • NZOZ Przychodnia Specjalistyczna Medica

    Lublin, Lubelski 20-538
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lublin, Lubelski 20-538
    Poland

    Site Not Available

  • Gabinet Leczenia Otylosci i Chorob Dietozaleznych

    Bialystok, Podlaskie Voivodeship 15-281
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Bialystok, Podlaskie Voivodeship 15-281
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomorskie 81-338
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Gdynia, Pomorskie 81-338
    Poland

    Site Not Available

  • Centrum Zdrowia Metabolicznego

    Poznan, Wielkopolskie Voivodeship 60-589
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Poznan, Wielkopolskie Voivodeship 60-589
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej

    Lodz, 90-338
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Lodz, 90-338
    Poland

    Site Not Available

  • Novo Nordisk Investigational Site

    Tumen, Russia 625023
    Russian Federation

    Site Not Available

  • Tumen State Medical University

    Tumen, Russia 625023
    Russian Federation

    Site Not Available

  • LLC "Clinic of new technologies in Medicine"

    Dzerzhinskiy, 140091
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Dzerzhinskiy, 140091
    Russian Federation

    Site Not Available

  • Joint Stock Company "Medical technologies"

    Ekaterinburg, 620075
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Ekaterinburg, 620075
    Russian Federation

    Site Not Available

  • Endocrinological Dispensary of Department of healthcare ser.

    Moscow, 119034
    Russian Federation

    Site Not Available

  • Federal Bureau for Medical and Social Expertise

    Moscow, 127486
    Russian Federation

    Site Not Available

  • National Medical Research Center of Endocrinology

    Moscow, 117292
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Moscow, 117292
    Russian Federation

    Site Not Available

  • Joint Stock Company "Polyclinic Complex"

    Saint Petersburg, 190013
    Russian Federation

    Site Not Available

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Saint Petersburg, 194291
    Russian Federation

    Site Not Available

  • Novo Nordisk Investigational Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Univ of Alabama Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Los Angeles, California 90057
    United States

    Site Not Available

  • Velocity Clin Res Wstlke

    Los Angeles, California 90057
    United States

    Site Not Available

  • Clinical Trial Res Assoc,Inc

    Plantation, Florida 33324
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • East West Med Res Inst

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Midwest Inst For Clin Res

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Accellacare

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19104-3317
    United States

    Site Not Available

  • The University of Penn Center

    Philadelphia, Pennsylvania 19104-3317
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75230
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington, Virginia 22206
    United States

    Site Not Available

  • Washington Cntr Weight Mgmt

    Arlington, Virginia 22206
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

  • Selma Medical Associates

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

  • Capital Clin Res Ctr,LLC

    Olympia, Washington 98502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olympia, Washington 98502
    United States

    Site Not Available

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