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.
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
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
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
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
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
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
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
Finland3 sites
Obesity Research Unit
Helsinki, 00014
StudyCor
Jyväskylä, 40620
Seinäjoen keskussairaala
Seinäjoki, 60220
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
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Oral semaglutide |
| Oral semaglutide placebo | Placebo comparator | All 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted5 Sep 2021
- Study start13 Sep 2021
- Primary completion24 Mar 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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