OASIS 4

CompletedPhase 3Results posted

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

307

actual

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05564117

Org study IDNN9932-4954

Secondary ID2021-006534-40

Secondary IDU1111-1271-9056World Health Organization (WHO)

Timeline

Milestones

Study first posted2022-10-03actual

Study start2022-10-11actual

Primary completion2024-04-18actual

Study completion2024-05-07actual

Last update posted2026-02-25actual

Results first posted2026-02-25actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

Endpoints (54)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

18 endpoints

Primary/registry result

Percentage Change in Body Weight

Time frame:Baseline (week 0), end of treatment (week 64)

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change in body weight	95% CI
Oral Semaglutide 25 mg	-14.4	—
Placebo	-2.5	—

Treatment difference-11.4395% CI-13.88 – -8.98p<0.0001ANCOVA

Treatment policy estimand

Treatment difference-13.8795% CI-16.53 – -11.21p<0.0001Mixed model for repeated measures (MMRM)

Hypothetical estimand

Primary/registry result

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

Time frame:At end of treatment (week 64)

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 25 mg	152	—
	40	—
Placebo	28	—
	62	—

Treatment odds ratio7.3495% CI4.22 – 12.76p<0.0001Regression, Logistic

Week 64 responses were analysed using a binary logistic regression model with randomised treatment as factor and baseline body weight as covariate.

Treatment odds ratio25.2395% CI13.24 – 48.07p<0.0001Regression, Logistic

Hypothetical estimand

Primary/protocol endpoint

Percentage Change in Body Weight

Time frame:Baseline (week 0), end of treatment (week 64)

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

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

Time frame:At end of treatment (week 64)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

Time frame:At end of treatment (week 64)

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 25 mg	121	—
	71	—
Placebo	13	—
	77	—

Secondary/registry result

Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)

Time frame:At end of treatment (week 64)

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 25 mg	96	—
	96	—
Placebo	5	—
	85	—

Secondary/registry result

Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)

Time frame:At end of treatment (week 64)

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 25 mg	57	—
	135	—
Placebo	3	—
	87	—

Secondary/registry result

Change in Body Weight - Kilogram (kg)

Time frame:Baseline (week 0), end of treatment (week 64)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Oral Semaglutide 25 mg	-15.0	—
Placebo	-2.3	—

Secondary/registry result

Change in Body Mass Index (BMI)

Time frame:Baseline (week 0), end of treatment (week 64)

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram per square meter (kg/m^2)	95% CI
Oral Semaglutide 25 mg	-5.3	—
Placebo	-0.9	—

Secondary/registry result

Change in Waist Circumference

Time frame:Baseline (week 0), end of treatment (week 64)

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeter (cm)	95% CI
Oral Semaglutide 25 mg	-12.9	—
Placebo	-3.1	—

Secondary/registry result

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)

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 25 mg	77	—
	102	—
Placebo	9	—
	77	—

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

Time frame:At end of treatment (week 64)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Reduction ≥ 15% (Yes/No)

Time frame:At end of treatment (week 64)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Reduction ≥ 20% (Yes/No)

Time frame:At end of treatment (week 64)

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Weight - Kilogram (kg)

Time frame:Baseline (week 0), end of treatment (week 64)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:Baseline (week 0), end of treatment (week 64)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline (week 0), end of treatment (week 64)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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)

threshold achievement, improvement

Glycemic / diabetes

8 endpoints

Secondary/registry result

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (week 0), end of treatment (week 64)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Oral Semaglutide 25 mg	-0.3	—
Placebo	-0.0	—

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:Baseline (week 0), end of treatment (week 64)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Oral Semaglutide 25 mg	-7.3	—
Placebo	0.1	—

Secondary/registry result

Change in Fasting Serum Insulin - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

ratio, improvement

Posted result

Group	Value (mean), Ratio of fasting serum insulin	95% CI
Oral Semaglutide 25 mg	0.74	—
Placebo	1.03	—

Secondary/registry result

Number of Participants With Change in Glycaemic Status

Time frame:Baseline (week 0), end of treatment (week 64)

categorical status, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 25 mgNormo-glycaemia (week 0)	92	—
Normo-glycaemia (week 0)	5	—
Normo-glycaemia (week 0)	0	—
Pre-diabetes (week 0)	64	—
Pre-diabetes (week 0)	25	—
Pre-diabetes (week 0)	1	—
Diabetes (week 0)	0	—
Diabetes (week 0)	3	—
Diabetes (week 0)	0	—
PlaceboNormo-glycaemia (week 0)	35	—
Normo-glycaemia (week 0)	11	—
Normo-glycaemia (week 0)	0	—
Pre-diabetes (week 0)	13	—
Pre-diabetes (week 0)	26	—
Pre-diabetes (week 0)	0	—
Diabetes (week 0)	0	—
Diabetes (week 0)	0	—
Diabetes (week 0)	1	—

Secondary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (week 0), end of treatment (week 64)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:Baseline (week 0), end of treatment (week 64)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Serum Insulin - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

ratio, improvement

Secondary/protocol endpoint

Number of Participants With Change in Glycaemic Status

Time frame:Baseline (week 0), end of treatment (week 64)

categorical status, improvement

LOINC 4548-4

Cardiometabolic biomarkers

20 endpoints

Secondary/registry result

Change in Systolic Blood Pressure

Time frame:Baseline (week 0), end of treatment (week 64)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Oral Semaglutide 25 mg	-7	—
Placebo	-5	—

Secondary/registry result

Change in Diastolic Blood Pressure

Time frame:Randomisation (week 0), end of treatment (week 64)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Oral Semaglutide 25 mg	-3	—
Placebo	-2	—

Secondary/registry result

Change in Total Cholesterol - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Oral Semaglutide 25 mg	0.96	—
Placebo	0.98	—

Secondary/registry result

Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL	95% CI
Oral Semaglutide 25 mg	1.04	—
Placebo	0.99	—

Secondary/registry result

Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL	95% CI
Oral Semaglutide 25 mg	0.96	—
Placebo	0.99	—

Secondary/registry result

Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL	95% CI
Oral Semaglutide 25 mg	0.80	—
Placebo	0.92	—

Secondary/registry result

Change in Triglycerides - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Oral Semaglutide 25 mg	0.80	—
Placebo	0.93	—

Secondary/registry result

Change in Free Fatty Acids - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of free fatty acids	95% CI
Oral Semaglutide 25 mg	0.86	—
Placebo	0.95	—

Secondary/registry result

Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Posted result

Group	Value (geometric_mean), Ratio of hsCRP	95% CI
Oral Semaglutide 25 mg	0.50	—
Placebo	0.91	—

Secondary/registry result

Change in Pulse

Time frame:Baseline (week 0), end of treatment (week 64)

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute (Beats/min)	95% CI
Oral Semaglutide 25 mg	2	—
Placebo	1	—

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:Baseline (week 0), end of treatment (week 64)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:Randomisation (week 0), end of treatment (week 64)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Total Cholesterol - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL) Cholesterol - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very Low-Density Lipoproteins (VLDL) Cholesterol - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Free Fatty Acids - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 64)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Pulse

Time frame:Baseline (week 0), end of treatment (week 64)

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

4 endpoints

Secondary/registry result

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)

IWQOL-Lite physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide 25 mg	16.8	—
Placebo	8.3	—

Secondary/registry result

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)

IWQOL-Lite physical

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 25 mg	104	—
	84	—
Placebo	31	—
	58	—

Secondary/protocol endpoint

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)

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

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)

IWQOL-Lite physical

threshold achievement, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 71)

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide 25 mg	1239	—
Placebo	432	—

Secondary/registry result

Number of Serious Treatment Emergent Adverse Events

Time frame:From baseline (week 0) to end of study (week 71)

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide 25 mg	17	—
Placebo	13	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 71)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Treatment Emergent Adverse Events

Time frame:From baseline (week 0) to end of study (week 71)

Serious AEs (any)

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Oral Semaglutide at a Dose of 25 mg in Adults with Overweight or Obesity.
The New England journal of medicine2025 Sep 18PMID40934115doi:10.1056/NEJMoa2500969via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.