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

Obesity Clinical Trial

— OASIS 1  

Official title:

Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Subjects With Overweight or Obesity (OASIS 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035095
• Other study ID #: NN9932-4737
• Secondary ID: U1111-1253-16702
• Status: Completed
• Phase: Phase 3
• Start date: September 13, 2021
• Est. completion date: May 12, 2023

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: May 12, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• 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

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Hamilton Med Res Group	Hamilton	Ontario
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	Ocean West Research Clinic	Surrey	British Columbia
Denmark	Center for Klinisk Metabolisk Forskning	Hellerup
Denmark	Hvidovre Hospital Endokrinologisk forsknings afsnit 159	Hvidovre
Denmark	Sjællands Universitetshospital	Køge
Finland	Obesity Research Unit	Helsinki
Finland	StudyCor	Jyväskylä
Finland	Seinäjoen keskussairaala	Seinäjoki
France	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	Groupe Hospitalier Mutualiste Des Portes Du Sud	Venissieux
Germany	InnoDiab Forschung GmbH	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	Erlinger	Stuttgart
Germany	Zentrum für klinische Studien Allgäu Oberschwaben	Wangen
Japan	Chiba University Hospital_Diabetes, Metabolism and Endocrinology	Chiba-shi, Chiba
Japan	Suidoubashi Medical Clinic	Chiyoda-ku, Tokyo
Japan	Higashi-shinjuku clinic	Tokyo
Poland	Gabinet Leczenia Otylosci i Chorob Dietozaleznych	Bialystok	Podlaskie Voivodeship
Poland	Centrum Medyczne Pratia Gdynia	Gdynia	Pomorskie
Poland	Centrum Terapii Wspolczesnej	Lodz
Poland	NZOZ Przychodnia Specjalistyczna Medica	Lublin	Lubelski
Poland	Centrum Zdrowia Metabolicznego	Poznan	Wielkopolskie Voivodeship
Russian Federation	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	Federal Bureau for Medical and Social Expertise	Moscow
Russian Federation	National Medical Research Center of Endocrinology	Moscow
Russian Federation	Joint Stock Company "Polyclinic Complex"	Saint Petersburg
Russian Federation	Leningrad Regional Clinical Hospital	Saint Petersburg
Russian Federation	Tumen State Medical University	Tumen	Russia
United States	Washington Cntr Weight Mgmt	Arlington	Virginia
United States	Univ of Alabama Birmingham	Birmingham	Alabama
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	East West Med Res Inst	Honolulu	Hawaii
United States	Midwest Inst For Clin Res	Indianapolis	Indiana
United States	Velocity Clin Res Wstlke	Los Angeles	California
United States	Capital Clin Res Ctr,LLC	Olympia	Washington
United States	The University of Penn Center	Philadelphia	Pennsylvania
United States	Clinical Trial Res Assoc,Inc	Plantation	Florida
United States	Accellacare	Wilmington	North Carolina
United States	Selma Medical Associates	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Finland,  France,  Germany,  Japan,  Poland,  Russian Federation, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in body weight	percentage-point	From baseline (week 0) to end of treatment (week 68)
Primary	Achievement of body weight reduction greater than or equal to 5% (Yes/No)	Count of participants	At end-of-treatment (week 68)
Secondary	Achievement of body weight reduction greater than or equal to 10% (Yes/No)	Count of participants	At end of treatment (week 68)
Secondary	Change in Short Form-36 (SF-36) Physical Function	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in IWQOL-Lite-CT Physical Function	Score points	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in waist circumference	measured in cm	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of body weight reduction greater than or equal to 15% (Yes/No)	Count of participants	At end of treatment (week 68)
Secondary	Achievement of body weight reduction greater than or equal to 20% (Yes/No)	Count of participants	At end of treatment (week 68)
Secondary	Change in body mass index (BMI)	measured in kg/m^2	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in systolic blood pressure	measured in mmHg	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in diastolic blood pressure	measured in mmHg	From randomisation (week 0) to end of treatment (week 68)
Secondary	Change in HbA1c (glycated haemoglobin)	percentage-point	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in fasting plasma glucose (FPG)	measured in mg/dL	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in fasting serum insulin	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in lipids: Total cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in lipids: HDL (high density lipoprotein) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in lipids: LDL (low-density lipoprotein) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in lipids: VLDL (very-low density lipoprotein) cholesterol	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in lipids: Triglycerides	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in lipids: Free fatty acids	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in high sensitivity C-Reactive Protein	Ratio to baseline	From baseline (week 0) to end of treatment (week 68)
Secondary	Number of treatment emergent adverse events	Count of events	From baseline (week 0) to end-of-trial (week 75)
Secondary	Number of serious adverse events	Count of events	From baseline (week 0) to end-of-trial (week 75)