OverweightPhase 3OASIS 4NCT05564117

Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range

A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 23 sites in 4 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

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: 307 participants
Where: 23 sitesin 4 countries
Study dates: 11 Oct 2022to 7 May 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Male or female, age greater than or equal to 18 years at the time of signing informed consent
Body mass index (BMI) of
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 (CV) 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

A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records
HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening

Trial locations and contacts

23 sites in 4 countries.

Country

City, postcode or hospital

23 sites in 4 countries

Germany8 sites

InnoDiab Forschung GmbH
Essen, 45136
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Lingen, 49808
MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin
Münster, 48153
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
Praxis für Prävention und Therapie, Drs Jacob
Villingen-Schwenningen, 78048
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, 88239

Other trials in Germany

United States7 sites

Washington Cntr Weight Mgmt
Arlington, Virginia, 22206
Univsty Of AL At Birmingham
Birmingham, Alabama, 35294
FDRC
Costa Mesa, California, 92627
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302
East West Medical Research Institute_Honolulu
Honolulu, Hawaii, 96814
Accellacare
Wilmington, North Carolina, 28401
Selma Medical Associates
Winchester, Virginia, 22601

Other trials in United States

Poland6 sites

Gabinet Leczenia Otylosci i Chorob Dietozaleznych
Bialystok, Podlaskie Voivodeship, 15-281
Beata Miklaszewicz&Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, 59-220
ETG Lublin
Lublin, Lublin Voivodeship, 20-412
Centrum Zdrowia Metabolicznego
Poznan, Wielkopolskie Voivodeship, 60-589
ETG Siedlce
Siedlce, Masovian Voivodeship, 08-110
ETG Warszawa Sp. z o.o.
Warsaw, Masovian Voivodeship, 02-677

Other trials in Poland

Canada2 sites

Wharton Med Clin Trials
Hamilton, Ontario, L8L 5G8
G.A. Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7

Other trials in Canada

About this study

Official title: Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity

This study will look how well semaglutide tablets taken once daily helps people with body weight above the healthy range. Participants will either get semaglutide 25 milligram (mg) once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week screening period, 64 weeks of treatment period and 7 weeks of follow up period.

Conditions: Overweight, Obesity
Being tested: Semaglutide, Placebo semaglutide
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
Semaglutide tablets orally once daily for 64 weeks.
Placebo semaglutideDrug
Semaglutide placebo-matching tablets orally once daily for 64 weeks.

Study groups in NCT05564117
Study group	Role	What they receive
Oral semaglutide 25 mg	Experimental	Participants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64). Receives: Drug: Semaglutide
Oral semaglutide placebo	Placebo comparator	Participants will receive placebo tablets matched to semaglutide orally once daily for 64 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 64) is presented.
Measured: Baseline (week 0), end of treatment (week 64)
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.
Measured: At end of treatment (week 64)

Secondary outcomes (25)

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
Number of participants who achieved ≥ 10% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 10% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 10% weight reduction.
Measured: At end of treatment (week 64)
Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)
Number of participants who achieved ≥ 15% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 15% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 15% weight reduction.
Measured: At end of treatment (week 64)
Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)
Number of participants who achieved ≥ 20% weight reduction at end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 20% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 20% weight reduction.
Measured: At end of treatment (week 64)
Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT)
Change in physical function domain score IWQOL-Lite-CT from baseline (week 0) to the end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning. This outcome measure shows results for 'physical function domain'.
Measured: Baseline (week 0), end of treatment (week 64)
Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No)
Number of participants who achieved ≥14.6 in IWQOL-Lite-CT PFD score (Yes/No) from baseline to end of treatment (week 64) is presented. IWQOL-Lite-CT is a 20-item obesity-specific PRO measures used to assess the impact of body weight changes on patient's physical (7 items, where 5 of the items comprise the physical functioning sub-domain) and psychosocial functioning (13 items) in 3 composite scores (Physical Function, Physical and Psychosocial) and a Total score, all ranging from 0 to 100 with higher scores reflecting better levels of functioning.
Measured: Baseline (week 0), end of treatment (week 64)
Change in Body Weight - Kilogram (kg)
Change in body weight from baseline (week 0) to end of treatment (week 64) is presented.
Measured: Baseline (week 0), end of treatment (week 64)
Change in Body Mass Index (BMI)
Change in BMI from baseline (week 0) to end of treatment (week 64) is presented.
Measured: Baseline (week 0), end of treatment (week 64)
Change in Waist Circumference
Change in waist circumference from baseline (week 0) to end of treatment (week 64) is presented.
Measured: Baseline (week 0), end of treatment (week 64)
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline (week 0) to end of treatment (week 64) is presented.
Measured: Baseline (week 0), end of treatment (week 64)
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from randomisation (week 0) to end of treatment (week 64) is presented.
Measured: Randomisation (week 0), end of treatment (week 64)
Change in Glycosylated Haemoglobin (HbA1c)
Change in HbA1c from baseline (week 0) to end of treatment (week 64) is presented.
Measured: Baseline (week 0), end of treatment (week 64)
Change in Total Cholesterol - Ratio to Baseline
Change in total cholesterol (measured in millimoles per liter [mmol/L]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), end of treatment (week 64)
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Change in high density lipoprotein (HDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), end of treatment (week 64)
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Change in low density lipoprotein (LDL) cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), end of treatment (week 64)
Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline
Change in VLDL cholesterol (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), end of treatment (week 64)
Change in Triglycerides - Ratio to Baseline
Change in triglycerides (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), end of treatment (week 64)
Change in Free Fatty Acids - Ratio to Baseline
Change in free fatty acids (measured in mmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), end of treatment (week 64)
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Change in high sensitivity C-Reactive Protein (hsCRP) (milligram per litre [mg/L]) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), end of treatment (week 64)
Change in Fasting Plasma Glucose (FPG)
Change in FPG measured in milligrams per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 64) is presented.
Measured: Baseline (week 0), end of treatment (week 64)
Change in Fasting Serum Insulin - Ratio to Baseline
Change in fasting serum insulin measured in picomoles per liter (pmol/L) from baseline (week 0) to end of treatment (week 64) is presented as ratio to baseline (week 0).
Measured: Baseline (week 0), end of treatment (week 64)
Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no)
Number of participants with BMI <30 at the end of treatment (week 64) from baseline (week 0) is presented. The outcome measure is applicable for participants with BMI ≥ 30 at baseline (week 0). In the reported data, 'Yes' infers the number of participants who have achieved BMI less than 30, whereas 'No' infers the number of participants who have not achieved BMI less than 30 at week 64.
Measured: From baseline (week 0) to end of treatment (week 64)
Number of Participants With Change in Glycaemic Status
Number of participants with change in glycaemic status from baseline (week 0) to the end of treatment (week 64) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: 5.7% <= HbA1c < 6.5% 3) Type 2 diabetes: HbA1c >=6.5%.
Measured: Baseline (week 0), end of treatment (week 64)
Number of Treatment Emergent Adverse Events (TEAEs)
Number of treatment emergent adverse events from baseline (week 0) to end of study (week 71) is presented. An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
Measured: From baseline (week 0) to end of study (week 71)
Number of Serious Treatment Emergent Adverse Events
Number of treatment emergent serious adverse events from baseline (week 0) to end of study (week 71) is presented. A serious adverse event (SAE) is any untoward medical occurrence that fulfils at least one of following criteria: results in death; is life-threatening; requires inpatient or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is congenital anomaly/birth defect; important medical event.
Measured: From baseline (week 0) to end of study (week 71)
Change in Pulse
Change in pulse from baseline (week 0) to end of treatment (week 64) is presented.
Measured: Baseline (week 0), end of treatment (week 64)

Timeline

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

11 Oct 20227 May 2024

First posted3 Oct 2022
Study start11 Oct 2022
Primary completion18 Apr 2024
Study completion7 May 2024

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 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: 307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05564117
Sponsor's protocol ID: NN9932-4954
Other IDs: U1111-1271-9056, 2021-006534-40
Acronym: OASIS 4
Status last verified: Feb 2026
First submitted: 29 Sep 2022
Last updated: 25 Feb 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

Wharton S, Lingvay I, Bogdanski P, Duque do Vale R, Jacob S, Karlsson T, Shaji C, Rubino D, Garvey WT; OASIS 4 Study Group. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity. N Engl J Med. 2025 Sep 18;393(11):1077-1087. doi: 10.1056/NEJMoa2500969.
PubMed 40934115

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Oral Semaglutide 25 mg Once Daily in Adults With Overweight or Obesity
ClinicalTrials.gov ID: NCT05564117
Acronym / sponsor ID: OASIS 4 / NN9932-4954
Conditions: Overweight, Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 307 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 11 Oct 2022 (actual)
Primary completion: 18 Apr 2024 (actual)
Study completion: 7 May 2024 (actual)
First posted: 3 Oct 2022 (actual)
Results: Posted 25 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
Oral semaglutide 25 mg	Experimental	Drug: SemaglutideParticipants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 64 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), and 25 mg (weeks 13 to 64).
Oral semaglutide placebo	Placebo comparator	Drug: Placebo semaglutideParticipants will receive placebo tablets matched to semaglutide orally once daily for 64 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 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
Male or female, age greater than or equal to 18 years at the time of signing informed consent
Body mass index (BMI) of
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 (CV) disease OR
Greater than or equal to 30.0 kg/m^2

Key exclusion criteria (2 listed)

A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90 days before screening irrespective of medical records
HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening

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
SemaglutideSemaglutide tablets orally once daily for 64 weeks.	Drug	Oral semaglutide 25 mg
Placebo semaglutideSemaglutide placebo-matching tablets orally once daily for 64 weeks.	Drug	Oral semaglutide placebo

Primary outcome

Percentage Change in Body Weight
Time frame: Baseline (week 0), end of treatment (week 64)
Percentage change in body weight from baseline (week 0) to end of treatment (week 64) is presented.
Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)
Time frame: At end of treatment (week 64)
Number of participants who achieved ≥5% body weight reduction at the end of treatment (week 64) from baseline (week 0) is presented. In the reported data, 'Yes' infers the number of participants who have achieved greater than or equal to 5% weight reduction, whereas 'No' infers the number of participants who have not achieved greater than or equal to 5% weight reduction.

25 secondary outcomes

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)
Time frame: At end of treatment (week 64)
Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)
Time frame: At end of treatment (week 64)
Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)
Time frame: At end of treatment (week 64)
Change in Physical Function Domain (5-items) Score Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT)
Time frame: Baseline (week 0), end of treatment (week 64)
Number of Participants Who Achieved ≥14.6 IWQOL-Lite-CT Physical Function Domain (PFD) Score (Yes/No)
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Body Weight - Kilogram (kg)
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Body Mass Index (BMI)
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Waist Circumference
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Systolic Blood Pressure
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Diastolic Blood Pressure
Time frame: Randomisation (week 0), end of treatment (week 64)
Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Total Cholesterol - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 64)
Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Triglycerides - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Free Fatty Acids - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 64)
Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Fasting Plasma Glucose (FPG)
Time frame: Baseline (week 0), end of treatment (week 64)
Change in Fasting Serum Insulin - Ratio to Baseline
Time frame: Baseline (week 0), end of treatment (week 64)
Number of Participants With Body Mass Index (BMI) Less Than (<) 30 at Week 64 (Yes/no)
Time frame: From baseline (week 0) to end of treatment (week 64)
Number of Participants With Change in Glycaemic Status
Time frame: Baseline (week 0), end of treatment (week 64)
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline (week 0) to end of study (week 71)
Number of Serious Treatment Emergent Adverse Events
Time frame: From baseline (week 0) to end of study (week 71)
Change in Pulse
Time frame: Baseline (week 0), end of treatment (week 64)

Results and safety

Results posted to the registry on 25 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Semaglutide 25 mg	205	196
Placebo	102	94

Primary outcome: Percentage Change in Body Weight

Time frame: Baseline (week 0), end of treatment (week 64). Mean (Standard Deviation). Unit: Percentage change in body weight

Measure	Oral Semaglutide 25 mg n = 192	Placebo n = 90
Value	-14.4 (10.5)	-2.5 (7.9)

Oral Semaglutide 25 mg vs Placebo: Treatment difference: -11.43 (95% CI -13.88 to -8.98), p <0.0001, ANCOVA
Oral Semaglutide 25 mg vs Placebo: Treatment difference: -13.87 (95% CI -16.53 to -11.21), p <0.0001, Mixed model for repeated measures (MMRM)

Population analysed: FAS included all randomised participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = participants with available data for this outcome measure.

Primary outcome: Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)

Time frame: At end of treatment (week 64). Count of participants. Unit: Participants

Measure	Oral Semaglutide 25 mg n = 192	Placebo n = 90
Yes	152	28
No	40	62

Oral Semaglutide 25 mg vs Placebo: Treatment odds ratio: 7.34 (95% CI 4.22 to 12.76), p <0.0001, Regression, Logistic
Oral Semaglutide 25 mg vs Placebo: Treatment odds ratio: 25.23 (95% CI 13.24 to 48.07), p <0.0001, Regression, Logistic

25 secondary outcomes are reported in the full results.

Adverse events

Time frame: From week 0 to week 71. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Semaglutide 25 mg	8 of 204 (3.9%)	172 of 204 (84.3%)	0 of 205
Placebo	9 of 102 (8.8%)	79 of 102 (77.5%)	0 of 102

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40934115Wharton S, Lingvay I, Bogdanski P, Duque do Vale R, Jacob S, Karlsson T, Shaji C, Rubino D, Garvey WT; OASIS 4 Study Group. Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity. N Engl J Med. 2025 Sep 18;393(11):1077-1087. doi: 10.1056/NEJMoa2500969.
Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Related trials for Overweight

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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. This study is not recruiting at the moment.

Clinical Transparency dept. 2834 study director

Novo Nordisk A/S

23 sites in 4 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 23 sites in 4 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany, United States, Poland, Canada. 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?

Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Body Weight (time frame: Baseline (week 0), end of treatment (week 64)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05564117, which also lists 1 linked publication.

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 25 Feb 2026.