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

NCT05035095 | Completed Phase 3 FDA Drug

• 3 other identifiers: NN9932-4737U1111-1253-16702020-002953-11
• Study Type: interventional
• Target: 667
• Locations: 9 countries
• Sites: 56

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Relative change in body weight

  percentage-point

  From baseline (week 0) to end of treatment (week 68)

• Achievement of body weight reduction greater than or equal to 5% (Yes/No)

  Count of participants

  At end-of-treatment (week 68)

Secondary Outcomes (21)

• Achievement of body weight reduction greater than or equal to 10% (Yes/No)

  At end of treatment (week 68)

• Change in Short Form-36 (SF-36) Physical Function

  From baseline (week 0) to end of treatment (week 68)

• Change in IWQOL-Lite-CT Physical Function

  From baseline (week 0) to end of treatment (week 68)

• Change in waist circumference

  From baseline (week 0) to end of treatment (week 68)

• Achievement of body weight reduction greater than or equal to 15% (Yes/No)

  At end of treatment (week 68)

Study Arms (2)

Oral semaglutide

EXPERIMENTAL

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)

Drug: Oral semaglutide

Oral semaglutide placebo

PLACEBO COMPARATOR

All participants are given once daily dose for 68 weeks

Drug: Placebo (semaglutide)

Interventions

Oral semaglutide DRUG

Participants will receive a daily dose of oral semaglutide.

Oral semaglutide

Placebo (semaglutide) DRUG

Oral placebo (semaglutide) once daily. Planned treatment duration will be 68 weeks.

Oral semaglutide placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (56)

Univ of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Velocity Clin Res Los Angeles

Los Angeles, California, 90017, United States

Location

The Chappel Group Research

Kissimmee, Florida, 34744, United States

Location

Clinical Trial Res Assoc,Inc

Plantation, Florida, 33324, United States

Location

East West Med Res Inst

Honolulu, Hawaii, 96814, United States

Location

Midwest Inst For Clin Res

Indianapolis, Indiana, 46260, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

The University of Penn Center

Philadelphia, Pennsylvania, 19104-3317, United States

Location

Velocity Clinical Res-Dallas

Dallas, Texas, 75230, United States

Location

Washington Cntr Weight Mgmt

Arlington, Virginia, 22206, United States

Location

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

Location

Capital Clin Res Ctr,LLC

Olympia, Washington, 98502, United States

Location

Ocean West Research Clinic

Surrey, British Columbia, V3Z 2N6, Canada

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Wharton Med Clin Trials

Hamilton, Ontario, L8L 5G8, Canada

Location

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, L8M 1K7, Canada

Location

Center for Klinisk Metabolisk Forskning

Hellerup, 2900, Denmark

Location

Hvidovre Hospital Endokrinologisk forsknings afsnit 159

Hvidovre, 2650, Denmark

Location

Sjællands Universitetshospital, Køge - Medicinsk Afdeling

Køge, 4600, Denmark

Location

Slagelse Sygehus Ambulatorium for hjertesygdomme

Slagelse, 4200, Denmark

Location

Obesity Research Unit

Helsinki, 00014, Finland

Location

StudyCor

Jyväskylä, 40620, Finland

Location

Seinäjoen keskussairaala

Seinäjoki, 60220, Finland

Location

Les Hopitaux de Chartres-Hopital Louis Pasteur

Le Coudray, 28630, France

Location

Fondation Hôtel-Dieu

Le Creusot, 71200, France

Location

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

Le Creusot, 71200, France

Location

Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2

Pessac, 33600, France

Location

Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1

Saint-Herblain, 44800, France

Location

Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

Toulouse, 31054, France

Location

Centre de Recherche Clinique Portes Du Sud

Vénissieux, 69200, France

Location

InnoDiab Forschung GmbH

Essen, 45136, Germany

Location

Praxis Dr. med. M. Esser

Essen, 45219, Germany

Location

Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR

Hamburg, 22041, Germany

Location

Milek, Hohenmölsen

Hohenmölsen, 06679, Germany

Location

RED-Institut für medizinische Forschung und Fortbildung GmbH

Oldenburg in Holstein, 23758, Germany

Location

Praxis Dr. med. Wenzl-Bauer

Rehlingen-Siersburg, 66780, Germany

Location

MZM Praxis Drs. Erlinger

Stuttgart, 70378, Germany

Location

Zentrum für klinische Studien Allgäu Oberschwaben

Wangen, 88239, Germany

Location

Chiba University Hospital_Diabetes, Metabolism and Endocrinology

Chiba-shi, Chiba, 260-8677, Japan

Location

Suidoubashi Medical Clinic

Chiyoda-ku, Tokyo, 101-0065, Japan

Location

Higashi-shinjuku clinic

Tokyo, 169-0072, Japan

Location

NZOZ Przychodnia Specjalistyczna Medica

Lublin, Lubelski, 20-538, Poland

Location

Gabinet Leczenia Otylosci i Chorob Dietozaleznych

Bialystok, Podlaskie Voivodeship, 15-281, Poland

Location

Centrum Medyczne Pratia Gdynia

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Centrum Zdrowia Metabolicznego

Poznan, Wielkopolskie Voivodeship, 60-589, Poland

Location

Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

Lodz, 90-338, Poland

Location

Tumen State Medical University

Tyumen, Russia, 625023, Russia

Location

LLC "Clinic of new technologies in Medicine"

Dzerzhinskiy, 140091, Russia

Location

FSBI 'I.I. Dedov National Medical Research Center of Endocrinology' of the MH of Russia

Moscow, 117292, Russia

Location

Endocrinological Dispensary of Department of healthcare ser.

Moscow, 119034, Russia

Location

Federal Bureau for Medical and Social Expertise

Moscow, 127486, Russia

Location

Joint Stock Company "Polyclinic Complex"

Saint Petersburg, 190013, Russia

Location

Leningrad Regional Clinical Hospital

Saint Petersburg, 194291, Russia

Location

Joint Stock Company "Medical technologies"

Yekaterinburg, 620075, Russia

Location

Related 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.

  PMID: 37385278 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 5, 2021
• Study Start: September 13, 2021
• Primary Completion: March 24, 2023
• Study Completion: May 12, 2023
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (13); PL (5); RU (8); DK (4); FR (7); CA (5); JP (3); FI (3); DE (8)