OASIS 3

CompletedPhase 3

Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in Chinese Adults Who Are Above a Healthy Weight Range (OASIS 3)

Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in Chinese Adults With Overweight or Obesity (OASIS 3)

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

200

actual

Study population

Obesity / overweight

Key I/E criterion

•HbA1c 7-10%

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 IDNCT05890976

Org study IDNN9932-4861

Secondary IDU1111-1266-2400World Health Organization (WHO)

Timeline

Milestones

Study start2023-05-30actual

Study first posted2023-06-06actual

Primary completion2025-01-16actual

Study completion2025-01-16actual

Last update posted2026-01-22actual

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

1. greater than or equal to 28.0 kilogram per meter square (kg/m^2) or

2. greater than or equal to 24.0 kg/m^2 with greater than or equal to 1 weight-related comorbidity (treated or untreated). Weight-related comorbidities should be hypertension, T2D, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

•History of at least one self-reported unsuccessful dietary effort to lose body weight.

For participants with T2D at screening the following inclusion criteria apply in addition to criteria 1- 4:

•Diagnosed with T2D greater than or equal to 180 days prior to screening.

•Treated with either diet and exercise alone or stable treatment (same drug(s) or active ingredient, dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OAD)s alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or glitazone).

•HbA1c 7.0 - 10.0 percent (53 - 86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening.

Exclusion criteria

Participants without T2D at screening:

•HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening.

•History of type 1 or type 2 diabetes.

•Treatment with glucose-lowering agent(s) within 90 days prior to screening.

Participants with T2D at screening:

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

•Renal impairment measured as estimated glomerular filtration rate (eGFR) value of lesser than 30 milli litre per min/1.73 square metre (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.

Endpoints (27)

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

Safety / tolerability / PK

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

8 endpoints

Primary/protocol endpoint

Relative Change in Body Weight

Time frame:From baseline (week 0) to end of treatment (week 44)

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent

Time frame:At end of treatment (week 44)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent

Time frame:At end of treatment (week 44)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent

Time frame:At end of treatment (week 44)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent

Time frame:At end of treatment (week 44)

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Body Mass Index (BMI)

Time frame:From baseline (week 0) to end of treatment (week 44)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:From baseline (week 0) to end of treatment (week 44)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-height ratio (WtHR)

Time frame:From baseline (week 0) to end of treatment (week 44)

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of treatment (week 44)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:From baseline (week 0) to end of treatment (week 44)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Serum Insulin

Time frame:From baseline (week 0) to end of treatment (week 44)

ratio, improvement

Cardiometabolic biomarkers

9 endpoints

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:From baseline (week 0) to end of treatment (week 44)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:From randomisation (week 0) to end of treatment (week 44)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:From baseline (week 0) to end of treatment (week 44)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High-density Lipoprotein (HDL) Cholesterol

Time frame:From baseline (week 0) to end of treatment (week 44)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low-density Lipoproteins (LDL) Cholesterol

Time frame:From baseline (week 0) to end of treatment (week 44)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very Low-density Lipoproteins (VLDL) Cholesterol

Time frame:From baseline (week 0) to end of treatment (week 44)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides

Time frame:From baseline (week 0) to end of treatment (week 44)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Free Fatty Acids

Time frame:From baseline (week 0) to end of treatment (week 44)

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in High Sensitivity C-reactive Protein (hsCRP)

Time frame:From baseline (week 0) to end of treatment (week 44)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

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

Time frame:From baseline (week 0) to end of treatment (week 44)

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From baseline (week 0) to end of treatment (week 44)

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ) - Total Score

Time frame:From randomisation (week 0) to end-of-treatment (week 44)

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events(TEAE's)

Time frame:From baseline (week 0) to end of treatment (week 44)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Serious Adverse Events(TESAE's)

Time frame:From baseline (week 0) to end of study (week 51)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

AUC 0-24h,sema,50mg,ss: Area Under The Semaglutide-Time Curve (0-24h) During a Dosing Interval at Steady State

Time frame:Week 20

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg

Time frame:Week 20

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 July 1, 2026 snapshot.