Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in People Who Are Overweight or Living With Obesity (OASIS 1)
- Conditions
- ObesityOverweight
- Interventions
- Drug: Oral semaglutideDrug: Placebo (semaglutide)
- Registration Number
- NCT05035095
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 667
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral semaglutide 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 placebo Placebo (semaglutide) All participants are given once daily dose for 68 weeks
- Primary Outcome Measures
Name Time Method Relative change in body weight From baseline (week 0) to end of treatment (week 68) percentage-point
Achievement of body weight reduction greater than or equal to 5% (Yes/No) At end-of-treatment (week 68) Count of participants
- Secondary Outcome Measures
Name Time Method Change in waist circumference From baseline (week 0) to end of treatment (week 68) measured in cm
Number of serious adverse events From baseline (week 0) to end-of-trial (week 75) Count of events
Change in Short Form-36 (SF-36) Physical Function From baseline (week 0) to end of treatment (week 68) Score points
Change in IWQOL-Lite-CT Physical Function From baseline (week 0) to end of treatment (week 68) Score points
Change in fasting plasma glucose (FPG) From baseline (week 0) to end of treatment (week 68) measured in mg/dL
Change in lipids: VLDL (very-low density lipoprotein) cholesterol From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in lipids: Triglycerides From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Number of treatment emergent adverse events From baseline (week 0) to end-of-trial (week 75) Count of events
Change in body mass index (BMI) From baseline (week 0) to end of treatment (week 68) measured in kg/m\^2
Change in diastolic blood pressure From randomisation (week 0) to end of treatment (week 68) measured in mmHg
Change in lipids: HDL (high density lipoprotein) cholesterol From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Achievement of body weight reduction greater than or equal to 15% (Yes/No) At end of treatment (week 68) Count of participants
Change in systolic blood pressure From baseline (week 0) to end of treatment (week 68) measured in mmHg
Change in HbA1c (glycated haemoglobin) From baseline (week 0) to end of treatment (week 68) percentage-point
Change in high sensitivity C-Reactive Protein From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Achievement of body weight reduction greater than or equal to 10% (Yes/No) At end of treatment (week 68) Count of participants
Achievement of body weight reduction greater than or equal to 20% (Yes/No) At end of treatment (week 68) Count of participants
Change in fasting serum insulin From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in lipids: Total cholesterol From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in lipids: LDL (low-density lipoprotein) cholesterol From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Change in lipids: Free fatty acids From baseline (week 0) to end of treatment (week 68) Ratio to baseline
Trial Locations
- Locations (51)
East West Med Res Inst
🇺🇸Honolulu, Hawaii, United States
Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-2
🇫🇷Le Creusot, France
InnoDiab Forschung GmbH
🇩🇪Essen, Germany
Suidoubashi Medical Clinic
🇯🇵Chiyoda-ku, Tokyo, Japan
Centrum Zdrowia Metabolicznego
🇵🇱Poznan, Wielkopolskie Voivodeship, Poland
Tumen State Medical University
🇷🇺Tumen, Russia, Russian Federation
Les Hopitaux de Chartres-Hopital Louis Pasteur
🇫🇷Le Coudray, France
Centrum Terapii Wspolczesnej
🇵🇱Lodz, Poland
Wharton Med Clin Trials
🇨🇦Hamilton, Ontario, Canada
Centrum Medyczne Pratia Gdynia
🇵🇱Gdynia, Pomorskie, Poland
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
🇫🇷Saint Herblain, France
Centre de Recherche Clinique Portes Du Sud
🇫🇷Venissieux, France
Higashi-shinjuku clinic
🇯🇵Tokyo, Japan
G.A. Research Associates Ltd.
🇨🇦Moncton, New Brunswick, Canada
Erlinger
🇩🇪Stuttgart, Germany
Leningrad Regional Clinical Hospital
🇷🇺Saint Petersburg, Russian Federation
Federal Bureau for Medical and Social Expertise
🇷🇺Moscow, Russian Federation
National Medical Research Center of Endocrinology
🇷🇺Moscow, Russian Federation
Obesity Research Unit
🇫🇮Helsinki, Finland
Univ of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Velocity Clin Res Wstlke
🇺🇸Los Angeles, California, United States
Clinical Trial Res Assoc,Inc
🇺🇸Plantation, Florida, United States
Midwest Inst For Clin Res
🇺🇸Indianapolis, Indiana, 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
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Hamilton Med Res Group
🇨🇦Hamilton, Ontario, Canada
Center for Klinisk Metabolisk Forskning
🇩🇰Hellerup, Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
🇩🇰Hvidovre, Denmark
Sjællands Universitetshospital
🇩🇰Køge, Denmark
StudyCor
🇫🇮Jyväskylä, Finland
Seinäjoen keskussairaala
🇫🇮Seinäjoki, Finland
Fondation Hôtel-Dieu
🇫🇷Le Creusot, France
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2
🇫🇷Pessac, France
Milek, Hohenmölsen
🇩🇪Hohenmölsen, Germany
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
🇩🇪Hamburg, Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
🇩🇪Oldenburg in Holstein, Germany
Praxis Dr. med. Wenzl-Bauer
🇩🇪Rehlingen-Siersburg, Germany
Chiba University Hospital_Diabetes, Metabolism and Endocrinology
🇯🇵Chiba-shi, Chiba, Japan
Zentrum für klinische Studien Allgäu Oberschwaben
🇩🇪Wangen, Germany
NZOZ Przychodnia Specjalistyczna Medica
🇵🇱Lublin, Lubelski, Poland
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
🇵🇱Bialystok, Podlaskie Voivodeship, Poland
LLC "Clinic of new technologies in Medicine"
🇷🇺Dzerzhinskiy, Russian Federation
Joint Stock Company "Medical technologies"
🇷🇺Ekaterinburg, Russian Federation
Endocrinological Dispensary of Department of healthcare ser.
🇷🇺Moscow, Russian Federation
Joint Stock Company "Polyclinic Complex"
🇷🇺Saint Petersburg, Russian Federation