OverweightPhase 3OASIS 5NCT07770841
Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 62 sites in 10 countries.
Trial summary
The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 62 sitesin 10 countries
- Study dates
- 12 Aug 2026to 11 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Female or male (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) of
- ≥ 27.0 kilogram per square meter (kg/m^2) with the presence of at least one weight-related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease.
- OR
- ≥ 30.0 kg/m^2.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
Who cannot join
- A self-reported change in body weight greater than (>) 5% within 90 days before screening irrespective of medical records.
- HbA1c ≥ 6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
- Consistent use of glucagon like peptide-1 (GLP-1) receptor agonists, including medication with glucagon like peptide-1 receptor agonist (GLP-1 RA) activity like dual GLP-1/gastric inhibitory peptide RAs, or amylin analogues before screening. Consistent use is defined as treatment.
Trial locations and contacts
62 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
62 sites in 10 countries
United States16 sites, 16 recruiting
- Recruiting
Uni of Alabama at Birmingham
Birmingham, Alabama, 35296
- Recruiting
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
- Recruiting
Corvallis Clinic PC Clinical Research Department
Corvallis, Oregon, 97330-3737
- Recruiting
Cedar Health Research
Dallas, Texas, 75251
- Recruiting
ERG Holding Company, LLC / Evolution Research Group, LLC
Delray Beach, Florida, 33445
- Recruiting
Headlands Research California, LLC
Escondido, California, 92025
- Recruiting
ERG Holding Company, LLC / Evolution Research Group, LLC
Fort Myers, Florida, 33192
- Recruiting
East West Med Res Inst
Honolulu, Hawaii, 96814
- Recruiting
National Research Institute - Huntington Park
Huntington Park, California, 90255
- Recruiting
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 89106
- Recruiting
Los Angeles Institute for Metabolic Research
Los Angeles, California, 90015
- Recruiting
L-MARC Research Center
Louisville, Kentucky, 40213
- Not yet recruiting
UPA Ctr Weight and Eating Dis
Philadelphia, Pennsylvania, 19104
- Recruiting
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
- Recruiting
Jedidiah Clinical Research
Tampa, Florida, 33619
- Recruiting
Selma Medical Associates
Winchester, Virginia, 22601-3834
Poland9 sites, 9 recruiting
- Not yet recruiting
Kresmed Sp. z o. o.
Bialystok, 15-481
- Not yet recruiting
Athleticomed Sp. z o.o.
Bydgoszcz, 85-752
- Recruiting
Gierach-Med
Bygdoszcz, 85-796
- Not yet recruiting
Santa Sp. z o.o.
Lodz, 90-302
- Recruiting
Centrum Zdrowia Metabolicznego Paweł Bogdański
Poznan, 60-589
- Recruiting
Velocity Nova Sp. z o.o.
Staszów, 28-200
- Recruiting
NBR Polska Tomasz Klodawski
Warsaw, 00-710
- Not yet recruiting
Care Access Polska Sp. Z o.o.
Warsaw, 00-719
- Recruiting
FutureMeds Sp. z o.o.
Warsaw, 03-291
Spain8 sites, 8 recruiting
- Recruiting
CPE Bola Azul_Endocrinología y Nutrición
Almería, 04009
- Recruiting
Hosp. Vithas Sevilla_Endocrino y Nutrición
Castilleja de la Cuesta, 41950
- Recruiting
Hospital Naval Ferrol
Ferrol, 15405
- Not yet recruiting
HU de Fuenlabrada_Endocrinología
Fuenlabrada, Madrid, 28042
- Recruiting
Clínica Palacios Madrid
Madrid, 28009
- Recruiting
Clínica Gaias Santiago
Santiago de Compostela, 15702
- Recruiting
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003
- Recruiting
H. Infanta Luisa_Endocrino y Obesidad
Seville, 41010
Bulgaria6 sites, 6 recruiting
- Recruiting
AIPSMC - DiMed EOOD
Haskovo, 6300
- Recruiting
Medical Center Zdrave Lom EOOD
Lom, 3600
- Not yet recruiting
IPMC - Dr. Elizabeta Dimitrova
Petrich, 2850
- Recruiting
MHAT Hadzhi Dimitar OOD
Sliven, 8800
- Recruiting
DCC Neoklinik EAD
Sofia, 1408
- Recruiting
DCC 1 Velingrad EOOD
Velingrad, 4600
Belgium5 sites, 5 recruiting
- Recruiting
Anima Research Center
Alken, 3570
- Recruiting
Imelda
Bonheiden, 2820
- Recruiting
UZ Brussel - Universitair Ziekenhuis Brussel
Brussels, 1090
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
KORMONT
Kluisbergen, 9690
Greece5 sites, 5 recruiting
- Recruiting
City Hospital Kliniki Monoprosopi I.K.E.
Kalamata, 24100
- Recruiting
Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit
Marousi, 15125
- Recruiting
Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
Peristeri, 121 31
- Recruiting
NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
Thessaloniki, 54635
- Recruiting
Thermi Clinic S.A. - Diabetes and Internal Medicine Department
Thessaloniki, 57001
France4 sites, 4 recruiting
- Recruiting
Hôpital Privé Saint Martin_Service de chirurgie digestive
Caen, 14000
- Recruiting
LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service d'endocrinologie
Le Coudray, 28630
- Recruiting
Hôpital Privé La Louvière_Service de chirurgie
Lille, 59800
- Recruiting
CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques
Vénissieux, 69200
Denmark3 sites, 3 recruiting
- Recruiting
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N, 8200
- Recruiting
Gentofte Hospital - Center for Klinisk Metabolisk Forskning
Hellerup, 2900
- Recruiting
Regionshospitalet Gødstrup, Hjertesygdomme
Herning, 7400
Netherlands3 sites, 3 recruiting
- Recruiting
Progress Clinical Research Amsterdam
Amsterdam, 1081 GN
- Recruiting
Praktijk Dokters van Nederhoven
Zwijndrecht, 3334 SB
- Recruiting
Progress Clinical Research Zwolle
Zwolle, 8025 AZ
Sweden3 sites, 3 recruiting
- Recruiting
CTC GoCo Mölndal
Mölndal, 431 53
- Recruiting
Enheten för Kliniska Studier (EKS), Örebro
Örebro, 703 62
- Recruiting
CTC Stockholm
Stockholm, 171 64
About this study
Official title: Efficacy and Safety of Once Daily Oral Semaglutide in Adults With Overweight or Obesity
The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Results from this study will help select the most optimal lower dose of oral semaglutide that can be used for treating participants living with overweight or obesity.
- Conditions
- Overweight, Obesity
- Being tested
- Semaglutide, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Participants will receive semaglutide orally.
PlaceboDrug
Participants will receive placebo orally.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants will receive two different oral doses of semaglutide as an adjunct to a reduced-calorie diet and increased physical activity. Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Participants will receive oral dose of placebo as an adjunct to a reduced-calorie diet and increased physical activity. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body weight
Measured as percentage change in body weight.
Measured: From baseline (week 0) to week 60
Secondary outcomes (22)
Achievement of body weight reduction greater than or equal to (≥) 5 percentage (%) (Yes/No)
Measured as count of participant.
Measured: At week 60
Achievement of body weight reduction ≥ 10% (Yes/No)
Measured as count of participant.
Measured: At week 60
Achievement of body weight reduction ≥ 15% (Yes/No)
Measured as count of participant.
Measured: At week 60
Change in waist circumference
Measured as centimeter (cm).
Measured: From baseline (week 0) to week 60
Change in body weight
Measured as kilogram (kg).
Measured: From baseline (week 0) to week 60
Change in high sensitivity C-Reactive Protein (hsCRP)
Measured as milligrams per deciliter (mg/dL).
Measured: From baseline (week 0) to week 60
Change in systolic blood pressure
Measured as millimetres of mercury (mmHg).
Measured: From baseline (week 0) to week 60
Change in diastolic blood pressure
Measured as (mmHg).
Measured: From baseline (week 0) to week 60
Change in fasting plasma glucose (FPG)
Measured as ratio to baseline.
Measured: From baseline (week 0) to week 60
Change in glycated haemoglobin (HbA1c)
Measured as %-point.
Measured: From baseline (week 0) to week 60
Change in glycaemic status
Measured as count of participants.
Measured: From baseline (week 0) to week 60
Change in lipids: Total cholesterol
Measured as ratio to baseline.
Measured: From baseline (week 0) to week 60
Change in lipids: High density lipoprotein (HDL) cholesterol
Measured as ratio to baseline.
Measured: From baseline (week 0) to week 60
Change in lipids: Non-HDL cholesterol
Measured as ratio to baseline.
Measured: From baseline (week 0) to week 60
Change in lipids: Low density lipoprotein (LDL) cholesterol
Measured as ratio to baseline.
Measured: From baseline (week 0) to week 60
Change in lipids: Very low density lipoprotein (VLDL) cholesterol
Measured as ratio to baseline.
Measured: From baseline (week 0) to week 60
Change in lipids: Triglycerides
Measured as ratio to baseline.
Measured: From baseline (week 0) to week 60
Change in lipids: Free fatty acids
Measured as ratio to baseline.
Measured: From baseline (week 0) to week 60
Change in waist-height ratio (WtHR)
Measured as change in waist-height ratio.
Measured: From baseline (week 0) to week 60
Number of treatment emergent adverse events
Measured as count of events.
Measured: From baseline (week 0) to week 67
Number of treatment emergent serious adverse events
Measured as count of events.
Measured: From baseline (week 0) to week 67
Number of treatment emergent adverse events leading to permanent treatment discontinuation
Measured as count of events.
Measured: From baseline (week 0) to week 67
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start12 Aug 2026
- Primary completion22 Feb 2028 (estimated)
- Study completion11 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770841
- Sponsor's protocol ID
- NN9932-8687
- Other IDs
- U1111-1331-5612, 2025-524626-18, 2025
- Acronym
- OASIS 5
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Once Daily Oral Semaglutide in Adults With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07770841
- Acronym / sponsor ID
- OASIS 5 / NN9932-8687
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 22 Feb 2028 (estimated)
- Study completion
- 11 Apr 2028 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo). Results from this study will help select the most optimal lower dose of oral semaglutide that can be used for treating participants living with overweight or obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideParticipants will receive two different oral doses of semaglutide as an adjunct to a reduced-calorie diet and increased physical activity. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive oral dose of placebo as an adjunct to a reduced-calorie diet and increased physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Female or male (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Body mass index (BMI) of
- OR
Key exclusion criteria (3 listed)
- A self-reported change in body weight greater than (>) 5% within 90 days before screening irrespective of medical records.
- HbA1c ≥ 6.5% (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
- Consistent use of glucagon like peptide-1 (GLP-1) receptor agonists, including medication with glucagon like peptide-1 receptor agonist (GLP-1 RA) activity like dual GLP-1/gastric inhibitory peptide RAs, or amylin analogues before screening. Consistent use is defined as treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideParticipants will receive semaglutide orally. | Drug | Semaglutide |
| PlaceboParticipants will receive placebo orally. | Drug | Placebo |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to week 60
Measured as percentage change in body weight.
22 secondary outcomes
Achievement of body weight reduction greater than or equal to (≥) 5 percentage (%) (Yes/No)
Time frame: At week 60
Achievement of body weight reduction ≥ 10% (Yes/No)
Time frame: At week 60
Achievement of body weight reduction ≥ 15% (Yes/No)
Time frame: At week 60
Change in waist circumference
Time frame: From baseline (week 0) to week 60
Change in body weight
Time frame: From baseline (week 0) to week 60
Change in high sensitivity C-Reactive Protein (hsCRP)
Time frame: From baseline (week 0) to week 60
Change in systolic blood pressure
Time frame: From baseline (week 0) to week 60
Change in diastolic blood pressure
Time frame: From baseline (week 0) to week 60
Change in fasting plasma glucose (FPG)
Time frame: From baseline (week 0) to week 60
Change in glycated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to week 60
Change in glycaemic status
Time frame: From baseline (week 0) to week 60
Change in lipids: Total cholesterol
Time frame: From baseline (week 0) to week 60
Change in lipids: High density lipoprotein (HDL) cholesterol
Time frame: From baseline (week 0) to week 60
Change in lipids: Non-HDL cholesterol
Time frame: From baseline (week 0) to week 60
Change in lipids: Low density lipoprotein (LDL) cholesterol
Time frame: From baseline (week 0) to week 60
Change in lipids: Very low density lipoprotein (VLDL) cholesterol
Time frame: From baseline (week 0) to week 60
Change in lipids: Triglycerides
Time frame: From baseline (week 0) to week 60
Change in lipids: Free fatty acids
Time frame: From baseline (week 0) to week 60
Change in waist-height ratio (WtHR)
Time frame: From baseline (week 0) to week 60
Number of treatment emergent adverse events
Time frame: From baseline (week 0) to week 67
Number of treatment emergent serious adverse events
Time frame: From baseline (week 0) to week 67
Number of treatment emergent adverse events leading to permanent treatment discontinuation
Time frame: From baseline (week 0) to week 67
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
62 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 62 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Poland, Spain, Bulgaria, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in body weight (time frame: From baseline (week 0) to week 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.