AzTrials
AzTrials

ObesityPhase 3OASIS 1NCT05035095

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

A Phase 3 study testing Oral semaglutide in people with Obesity and Overweight, run by Novo Nordisk A/S at 56 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight
What is being tested?
Oral semaglutide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
667 participants
Where
56 sitesin 9 countries
Study dates
13 Sep 2021to 12 May 2023
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

56 sites in 9 countries.

56 sites in 9 countries

United States13 sites
  • Washington Cntr Weight Mgmt

    Arlington, Virginia, 22206

  • Univ of Alabama Birmingham

    Birmingham, Alabama, 35233

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • Midwest Inst For Clin Res

    Indianapolis, Indiana, 46260

  • The Chappel Group Research

    Kissimmee, Florida, 34744

  • Velocity Clin Res Los Angeles

    Los Angeles, California, 90017

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • The University of Penn Center

    Philadelphia, Pennsylvania, 19104-3317

  • Clinical Trial Res Assoc,Inc

    Plantation, Florida, 33324

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Accellacare

    Wilmington, North Carolina, 28401

  • Selma Medical Associates

    Winchester, Virginia, 22601-3834

Other trials in United States

Germany8 sites
  • InnoDiab Forschung GmbH

    Essen, 45136

  • Praxis Dr. med. M. Esser

    Essen, 45219

  • Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR

    Hamburg, 22041

  • Dr. Milek medikum

    Hohenmölsen, 06679

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758

  • Praxis Dr. med. Wenzl-Bauer

    Rehlingen-Siersburg, 66780

  • MZM Praxis Drs. Erlinger

    Stuttgart, 70378

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239

Other trials in Germany

Russia8 sites
  • LLC "Clinic of new technologies in Medicine"

    Dzerzhinskiy, 140091

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

    Moscow, 117292

  • Endocrinological Dispensary of Department of healthcare ser.

    Moscow, 119034

  • Federal Bureau for Medical and Social Expertise

    Moscow, 127486

  • Joint Stock Company "Polyclinic Complex"

    Saint Petersburg, 190013

  • Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • Tumen State Medical University

    Tyumen, Russia, 625023

  • Joint Stock Company "Medical technologies"

    Yekaterinburg, 620075

Other trials in Russia

France7 sites
  • Les Hopitaux de Chartres-Hopital Louis Pasteur

    Le Coudray, 28630

  • Fondation Hôtel-Dieu

    Le Creusot, 71200

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

    Le Creusot, 71200

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

    Pessac, 33600

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

    Saint-Herblain, 44800

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2

    Toulouse, 31054

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200

Other trials in France

Canada5 sites
  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 1V7

  • Wharton Medical Clinic Clinical Trials (Hamilton)

    Hamilton, Ontario, L8L 5G8

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8M 1K7

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z 2N6

Other trials in Canada

Poland5 sites
  • Gabinet Leczenia Otylosci i Chorob Dietozaleznych

    Bialystok, Podlaskie Voivodeship, 15-281

  • Centrum Medyczne Pratia Gdynia

    Gdynia, Pomeranian Voivodeship, 81-338

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

    Lodz, 90-338

  • NZOZ Przychodnia Specjalistyczna Medica

    Lublin, Lubelski, 20-538

  • Centrum Zdrowia Metabolicznego Paweł Bogdański

    Poznan, Wielkopolskie Voivodeship, 60-589

Other trials in Poland

Denmark4 sites
  • Gentofte Hospital - Center for Klinisk Metabolisk Forskning

    Hellerup, 2900

  • Hvidovre Hospital Endokrinologisk forsknings afsnit 159

    Hvidovre, 2650

  • Sjællands Universitetshospital, Køge - Medicinsk Afdeling

    Køge, Region Sjælland, 4600

  • Slagelse Sygehus Ambulatorium for hjertesygdomme

    Slagelse, 4200

Other trials in Denmark

Finland3 sites
  • Obesity Research Unit

    Helsinki, 00014

  • StudyCor

    Jyväskylä, 40620

  • Seinäjoen keskussairaala

    Seinäjoki, 60220

Other trials in Finland

Japan3 sites
  • Chiba University Hospital_Diabetes, Metabolism and Endocrinology

    Chiba-shi, Chiba, 260-8677

  • Suidoubashi Medical Clinic_Internal Medicine

    Chiyoda-ku, Tokyo, 101-0065

  • Higashi-shinjuku clinic

    Tokyo, 169-0072

Other trials in Japan

About this study

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

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.

Read more

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
Obesity, Overweight
Being tested
Oral semaglutide, Placebo (semaglutide)
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral semaglutideDrug

    Participants will receive a daily dose of oral semaglutide.

  • Placebo (semaglutide)Drug

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

Study groups in NCT05035095
Study groupRoleWhat they receive
Oral semaglutideExperimentalParticipants 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)
Receives: Drug: Oral semaglutide
Oral semaglutide placeboPlacebo comparatorAll participants are given once daily dose for 68 weeks
Receives: Drug: Placebo (semaglutide)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change in Body Weight

    Percentage change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  2. Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 5% (Yes/No)

    Number of participants who achieved weight loss greater than or equal to 5% of their baseline body weight (yes/no) at end-of-treatment (week 68) is presented.

    Measured: At end-of-treatment (week 68)

Secondary outcomes (27)
  1. Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No)

    Number of participants who achieved weight loss greater than or equal ≥10% (Yes/No) at end-of-treatment (week 68) is presented.

    Measured: At end-of-treatment (week 68)

  2. Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 15% (Yes/No)

    Number of participants who achieved weight loss greater than or equal (≥) 15% (Yes/No) at end-of-treatment (week 68) is presented.

    Measured: At end-of-treatment (week 68)

  3. Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 20% (Yes/No)

    Number of participants who achieved weight loss greater than or equal (≥) 20% (Yes/No) at end-of-treatment (week 68) is presented.

    Measured: At end-of-treatment (week 68)

  4. Change in Waist Circumference

    Change in waist circumference from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  5. Change in Body Mass Index (BMI)

    Change in BMI from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  6. Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function

    The IWQOL-Lite-CT is a 20-item, obesity-specific patient-reported outcome (PRO) instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  7. Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Domain

    Change in SF-36 v2.0 physical functioning domain from baseline (week 0) to end of treatment (week 68) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 (indicates population mean) with a SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning. A positive change score indicates an improvement since baseline.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  8. Change in Systolic Blood Pressure

    Change in systolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  9. Change in Diastolic Blood Pressure

    Change in diastolic blood pressure from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  10. Change in Glycosylated Haemoglobin (HbA1c)

    Change in HbA1c from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  11. Change in Fasting Plasma Glucose (FPG)

    Change in FPG from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  12. Change in Fasting Serum Insulin (Pmol/L) - Ratio to Baseline

    Change in fasting serum insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to end-of-treatment (week 68) is presented as ratio to baseline.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  13. Change in Total Cholesterol (mg/dL) - Ratio to Baseline

    Change in total cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  14. Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline

    Change in high density lipoprotein (HDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  15. Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline

    Change in low density lipoprotein (LDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  16. Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline

    Change in very low density lipoprotein (VLDL) cholesterol (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  17. Change in Triglycerides (mg/dL) - Ratio to Baseline

    Change in triglycerides (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  18. Change in Free Fatty Acids (mg/dL) - Ratio to Baseline

    Change in free fatty acids (measured in milligrams per deciliter (mg/dL)) from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  19. Change in High Sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline

    Change in high sensitivity C-reactive protein (measured in Milligrams per liter (mg/L)) from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  20. Number of Treatment Emergent Adverse Events

    Number of treatment emergent adverse events from baseline (week 0) to end-of-study (week 75) is presented. An adverse event is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period. It is the time period in which participant was considered exposed to trial product.

    Measured: From baseline (week 0) to end-of-study (week 75)

  21. Number of Serious Adverse Events

    Number of serious adverse events from baseline (week 0) to end-of-study (week 75) is presented. A serious adverse event (SAE) was defined as any event that resulted in any of the following: death, life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or incapacity, congenital anomaly or birth defect or important medical event.

    Measured: From baseline (week 0) to end-of-study (week 75)

  22. Change in Body Weight - Kilogram (Kg)

    Change in body weight from baseline (week 0) to end-of-treatment (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  23. Number of Participants With Body Mass Index (BMI) Greater Than or Equal (≥) 30 at Baseline and BMI Lesser Than (<) 30 at Week 68 (Yes/no)

    Number of participants who's body mass index (BMI) greater than or equal (≥) 30 at baseline and BMI lesser than (<) 30 at week 68 (yes/no) from (week 0) to end-of-treatment (week 68) is presented.

    Measured: At end-of-treatment (week 68)

  24. Change in Pulse

    Change in pulse from baseline (week 0) to end-of-study (week 68) is presented.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  25. Number of Participants at Baseline and End of Treatment in Glycaemic Category (Normo-glycaemia, Pre-diabetes, Type 2 Diabetes)

    Number of participants in glycaemic categories, "normo-glycaemia, pre-diabetes and type 2 diabetes" at baseline (week 0) and end-of-treatment (week 68) are presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) less than (<) 5.7%; 2) Pre-diabetes: HbA1c 5.7 - 6.4% (both inclusive); 3) Type 2 diabetes: HbA1c greater than or equal to (>=) 6.5%.

    Measured: Baseline (week 0), end-of-treatment (week 68)

  26. Number of Participants With Change in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Domain (PFD) Greater Than or Equal (≥) 14.6 (Yes/No)

    The IWQOL-Lite-CT (measured as score on a scale) is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.

    Measured: At end-of-treatment (week 68)

  27. Number of Participants With Change in Short Form 36 v2.0 Acute (SF-36) Physical Functioning Score Greater Than or Equal (≥) 3.7 (Yes/No)

    Number of participants with change in SF-36 v2.0 physical functioning score ≥ 3.7 (yes/no) is presented. The SF-36 form, assesses participants' health-related quality of life (HRQoL) on eight domains of functional health and well-being as well as two component summary scores (physical component summary and mental component summary). A positive change score indicates an improvement since baseline. The scores for SF-36v2 Acute (SF-36) are norm-based scores, i.e., scores transformed to a scale where the 2009 US general population has a mean of 50 and an SD of 10. The range of possible scores for the SF-36 Physical Functioning score is 19.03-57.60. Higher scores indicate better physical functioning.

    Measured: From baseline (week 0) to end-of-treatment (week 68)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2021
  2. Study start13 Sep 2021
  3. Primary completion24 Mar 2023
  4. Study completion12 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
667 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05035095
Sponsor's protocol ID
NN9932-4737
Other IDs
U1111-1253-1670, 2020-002953-11
Acronym
OASIS 1
Status last verified
Apr 2026
First submitted
30 Aug 2021
Last updated
7 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Publications

  • 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.

    PubMed 37385278

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in