OASIS 1

CompletedPhase 3Results posted

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

667

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 IDNCT05035095

Org study IDNN9932-4737

Secondary ID2020-002953-11

Secondary IDU1111-1253-1670World Health Organization (WHO)

Timeline

Milestones

Study first posted2021-09-05actual

Study start2021-09-13actual

Primary completion2023-03-24actual

Study completion2023-05-12actual

Last update posted2026-05-07actual

Results first posted2026-05-07actual

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

•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

Exclusion criteria

•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

Endpoints (58)

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 68)

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage (%) change in body weight	95% CI
Oral Semaglutide 50 mg	-15.8	—
Placebo	-2.2	—

Treatment difference-12.7495% CI-14.15 – -11.33p<0.0001ANCOVA

Treatment policy estimand

Treatment difference-15.6395% CI-17.07 – -14.18p<0.0001Mixed Models Analysis

Hypothetical estimand

Primary/registry result

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

Time frame:At end-of-treatment (week 68)

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 50 mg	269	—
	48	—
Placebo	76	—
	219	—

Odds Ratio (OR)12.6295% CI8.50 – 18.74p<0.0001Regression, Logistic

Treatment policy estimand

Odds Ratio (OR)55.2195% CI32.98 – 92.41p<0.0001Regression, Logistic

Hypothetical estimand

Primary/protocol endpoint

Percentage Change in Body Weight

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

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

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

Time frame:At end-of-treatment (week 68)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No)

Time frame:At end-of-treatment (week 68)

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 50 mgYes	220	—
No	97	—
PlaceboYes	35	—
No	260	—

Secondary/registry result

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

Time frame:At end-of-treatment (week 68)

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 50 mgYes	170	—
No	147	—
PlaceboYes	17	—
No	278	—

Secondary/registry result

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

Time frame:At end-of-treatment (week 68)

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 50 mgYes	107	—
No	210	—
PlaceboYes	8	—
No	287	—

Secondary/registry result

Change in Waist Circumference

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

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeter (cm)	95% CI
Oral Semaglutide 50 mg	-13.4	—
Placebo	-2.8	—

Secondary/registry result

Change in Body Mass Index (BMI)

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

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram per meter square (kg/m^2)	95% CI
Oral Semaglutide 50 mg	-5.9	—
Placebo	-0.9	—

Secondary/registry result

Change in Body Weight - Kilogram (Kg)

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

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (kg)	95% CI
Oral Semaglutide 50 mg	-16.1	—
Placebo	-2.4	—

Secondary/registry result

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)

Time frame:At end-of-treatment (week 68)

BMI, change

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 50 mgYes	129	—
No	165	—
PlaceboYes	19	—
No	249	—

Secondary/protocol endpoint

Number of Participants Who Achieved Weight Loss Greater Than or Equal (≥) 10% (Yes/No)

Time frame:At end-of-treatment (week 68)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:At end-of-treatment (week 68)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:At end-of-treatment (week 68)

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference

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

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

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

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight - Kilogram (Kg)

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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)

Time frame:At end-of-treatment (week 68)

threshold achievement, improvement

Glycemic / diabetes

8 endpoints

Secondary/registry result

Change in Glycosylated Haemoglobin (HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Oral Semaglutide 50 mg	-0.2	—
Placebo	0.1	—

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Milligrams per deciliter (mg/dL)	95% CI
Oral Semaglutide 50 mg	-10.3	—
Placebo	-1.8	—

Secondary/registry result

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

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

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting serum insulin	95% CI
Oral Semaglutide 50 mg	0.67	—
Placebo	0.94	—

Secondary/registry result

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

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

categorical status, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 50 mgBaseline (week 0)	200	—
Baseline (week 0)	132	—
Baseline (week 0)	2	—
week 68	274	—
week 68	36	—
week 68	1	—
PlaceboBaseline (week 0)	200	—
Baseline (week 0)	130	—
Baseline (week 0)	3	—
week 68	139	—
week 68	143	—
week 68	4	—

Secondary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c)

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

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 68)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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

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

ratio, improvement

Secondary/protocol endpoint

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

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

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 68)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), Millimeter of mercury (mmHg)	95% CI
Oral Semaglutide 50 mg	-7	—
Placebo	-1	—

Secondary/registry result

Change in Diastolic Blood Pressure

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), Millimeter of mercury (mmHg)	95% CI
Oral Semaglutide 50 mg	-2	—
Placebo	-1	—

Secondary/registry result

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

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

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Oral Semaglutide 50 mg	0.97	—
Placebo	1.01	—

Secondary/registry result

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

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

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Oral Semaglutide 50 mg	1.05	—
Placebo	1.01	—

Secondary/registry result

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

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

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Oral Semaglutide 50 mg	0.98	—
Placebo	1.03	—

Secondary/registry result

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

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

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL cholesterol	95% CI
Oral Semaglutide 50 mg	0.77	—
Placebo	0.96	—

Secondary/registry result

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

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

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Oral Semaglutide 50 mg	0.77	—
Placebo	0.96	—

Secondary/registry result

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

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

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of free fatty acids	95% CI
Oral Semaglutide 50 mg	0.87	—
Placebo	1.00	—

Secondary/registry result

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

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

hs-CRP, change

ratio, improvement

LOINC 30522-7

Posted result

Group	Value (geometric_mean), Ratio of hsCRP	95% CI
Oral Semaglutide 50 mg	0.42	—
Placebo	0.85	—

Secondary/registry result

Change in Pulse

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

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats/min	95% CI
Oral Semaglutide 50 mg	4	—
Placebo	-0	—

Secondary/protocol endpoint

Change in Systolic Blood Pressure

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

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

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

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

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

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

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

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

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

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

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

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

VLDL, change

ratio, improvement

Secondary/protocol endpoint

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

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

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

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

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

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

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

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

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Pulse

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

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

8 endpoints

Secondary/registry result

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

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

IWQOL-Lite physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide 50 mg	14.5	—
Placebo	5.0	—

Secondary/registry result

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

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

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Oral Semaglutide 50 mg	2.4	—
Placebo	-0.0	—

Secondary/registry result

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)

Time frame:At end-of-treatment (week 68)

IWQOL-Lite physical

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 50 mgYes	149	—
No	149	—
PlaceboYes	87	—
No	191	—

Secondary/registry result

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)

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

SF-36 physical

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 50 mgYes	113	—
No	190	—
PlaceboYes	56	—
No	224	—

Secondary/protocol endpoint

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

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

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

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

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

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

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)

Time frame:At end-of-treatment (week 68)

IWQOL-Lite physical

threshold achievement, improvement

Secondary/protocol endpoint

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)

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

threshold achievement, improvement

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events

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

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide 50 mg	2500	—
Placebo	1577	—

Secondary/registry result

Number of Serious Adverse Events

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

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide 50 mg	44	—
Placebo	48	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events

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

Serious AEs (any)

event count, event

Publications (2)

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

Impact of weight on daily activities questionnaire in patients with overweight or obesity: Psychometric evaluation using data from the OASIS 1 trial.
Clinical obesity2025 Aug (month)PMID40452267doi:10.1111/cob.70015via pubmed nct search
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 (London, England)2023 Aug 26PMID37385278doi:10.1016/S0140-6736(23)01185-6via CT.gov background + 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.