OASIS 5

RecruitingPhase 3

Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight

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

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

450

Study population

Obesity / overweight

Eligibility highlights

Primary endpoint

•Body weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07770841

Org study IDNN9932-8687

Secondary ID2025

Secondary ID2025-524626-18European Medical Agency (EMA)

Secondary IDU1111-1331-5612Universal Trial Number

Timeline

Milestones

Study start2026-08-12actual

Study first posted2026-08-18actual

Last update posted2026-09-09actual

Primary completion2028-02-22estimated

Study completion2028-04-11estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

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.

•Female or male (sex at birth).

•Age 18 years or above at the time of signing the informed consent.

•Body mass index (BMI) of

1. ≥ 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.

2. ≥ 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% 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.

Endpoints (23)

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

Safety / tolerability / PK

Weight & body composition

7 endpoints

Primary/protocol endpoint

Relative change in body weight

Time frame:From baseline (week 0) to week 60

percent change from baseline, improvement

Secondary/protocol endpoint

Achievement of body weight reduction greater than or equal to (≥) 5 percentage (%) (Yes/No)

Time frame:At week 60

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction ≥ 10% (Yes/No)

Time frame:At week 60

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction ≥ 15% (Yes/No)

Time frame:At week 60

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-height ratio (WtHR)

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in glycaemic status

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Cardiometabolic biomarkers

10 endpoints

Secondary/protocol endpoint

Change in high sensitivity C-Reactive Protein (hsCRP)

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in lipids: Total cholesterol

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in lipids: High density lipoprotein (HDL) cholesterol

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in lipids: Non-HDL cholesterol

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in lipids: Low density lipoprotein (LDL) cholesterol

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in lipids: Very low density lipoprotein (VLDL) cholesterol

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in lipids: Triglycerides

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Secondary/protocol endpoint

Change in lipids: Free fatty acids

Time frame:From baseline (week 0) to week 60

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of treatment emergent adverse events

Time frame:From baseline (week 0) to week 67

event count, event

Secondary/protocol endpoint

Number of treatment emergent serious adverse events

Time frame:From baseline (week 0) to week 67

event count, event

Secondary/protocol endpoint

Number of treatment emergent adverse events leading to permanent treatment discontinuation

Time frame:From baseline (week 0) to week 67

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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 November 5, 2026 snapshot.