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OASIS 2

CompletedPhase 3

Research Study to Investigate How Well Semaglutide Tablets Taken Once Daily Work in East Asian People Who Are Overweight or Living With Obesity

Efficacy and Safety of Oral Semaglutide 50 mg Once Daily in East Asian Participants With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

201

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥27•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 IDNCT05132088

Org study IDNN9932-4738

Secondary IDU1111-1258-7561World Health Organization (WHO)

Timeline

Milestones

Study start2021-11-16actual

Study first posted2021-11-24actual

Primary completion2023-07-11actual

Study completion2023-09-01actual

Last update posted2025-06-06actual

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

Participants are eligible to be included in the study only if all the following criteria apply:

•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 above 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 greater than or equal to 2 weight related comorbidities (treated or untreated) according to the JASSO guideline or BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension, dyslipidaemia or type 2 diabetes (T2D)

•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), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic drugs (OADs) alone or in any combination (metformin, α-glucosidase (AGI), sulphonylureas (SU), glinides, SGLT2i (sodium-glucose co-transporter 2 inhibitor) or thiazolidinediones)

•HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) as measured by central laboratory at screening

Exclusion criteria

Participants without T2D only:

•HbA1c greater than or equal to 6.5% (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

•Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR brlow 15 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

Participants with T2D at screening only:

•Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 60 days prior to screening

•Receipt of any other anti-diabetic investigational drug within 90 days prior to screening for this study, or receipt of any investigational drugs not affecting diabetes within 30 days prior to screening for this study

•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 eGFR value of below 30 mL/min/1.73 m^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening

•In participants treated with SGLT2i, renal impairment measured as eGFR value of below 60 mL/min/1.73 m^2 according to CKD EPI creatinine equation as defined by KDIGO 2012 classification by the central laboratory at screening

The following criteria apply to all participants:

Obesity-related:

•Treatment with any medication indicated for weight management within 90 days prior to screening

•Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening, (2) lap banding, if the band has been removed greater than 1 year prior to screening, (3) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year prior to screening

•Uncontrolled thyroid disease per investigators discretion

•A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Endpoints (22)

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

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

9 endpoints

Primary/protocol endpoint

Relative change in body weight

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

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

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

Time frame:At end of treatment (week 68)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction greater than or equal to 10% (Yes/No)

Time frame:At end of treatment (week 68)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction greater than or equal to 15% (Yes/No)

Time frame:At end of treatment (week 68)

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Achievement of body weight reduction greater than or equal to 20% (Yes/No)

Time frame:At end of treatment (week 68)

≥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 68)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference measured according to the JASSO guideline

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

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Visceral Fat Area (VFA) measured by CT scan in a subset of the Japanese study population

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

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Visceral Fat Area (VFA) measured by CT scan in a subset of the Japanese study population

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

Visceral fat, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

9 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure

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

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in lipids: Total cholesterol

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

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in lipids: high density lipoprotein (HDL) cholesterol

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

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in lipids: low-density lipoprotein (LDL) cholesterol

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

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in lipids: very-low density lipoprotein (VLDL) cholesterol

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

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in lipids: Triglycerides

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

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in lipids: Free fatty acids

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

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in high sensitivity C Reactive Protein

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

hs-CRP, change

ratio, improvement

LOINC 30522-7

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in Physical function domain (5-items) score (IWQOL-Lite-CT)

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

IWQOL-Lite physical

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

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 (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 in an East Asian Population With Overweight or Obesity, With or Without Type 2 Diabetes: The OASIS 2 Randomized Clinical Trial.
JAMA internal medicine2025 Oct 1PMID40758358doi:10.1001/jamainternmed.2025.3599via 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 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.