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OverweightPhase 3OASIS 3NCT05890976

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

A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 16 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people who are above a healthy weight range to lose weight. Semaglutide tablets are a new medicine being tested to treat people living with excess body weight. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Obesity
What is being tested?
Semaglutide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
16 sitesChina
Study dates
30 May 2023to 16 Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 28.0 kilogram per meter square (kg/m^2) or
  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Peking University People's Hospital-Endocrinology

    Beijing, Beijing Municipality, 100044

  • Beijing Friendship Hospital, Capital Medical University-Endocrinology

    Beijing, Beijing Municipality, 100050

  • The First People's Hospital of Changde City-Endocrinology

    Changde, Hunan, 415003

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu, 213003

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

  • Huizhou Central People's Hospital-Endocrinology

    Huizhou, Guangdong, 516001

  • Jinan Central Hospital

    Ji'nan, Shandong, 250013

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Huaihe Hospital of Henan University-Endocrinology

    Kaifeng, Henan, 475000

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 450062

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Huashan Hospital Fudan University-Endocrinology

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Pudong New Area People's Hospital-Endocrinology

    Shanghai, Shanghai Municipality, 201200

  • Taihe Hospital-Endocrinology

    Shiyan, Hubei, 442008

  • General Hospital of Tianjin Medical University-Endocrinology

    Tianjin, Tianjin Municipality, 300052

  • The Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212001

Other trials in China

About this study

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

This study is being conducted to see if semaglutide tablets can be used as a treatment to help people who are above a healthy weight range to lose weight. Semaglutide tablets are a new medicine being tested to treat people living with excess body weight. Participants will either get semaglutide or placebo once daily morning for 44 weeks.

In addition to taking the medicine, participants will have talks with study staff about:

  • Healthy food choices
  • How to be more physically active
  • What participants can do to lose weight This study will last for about 1 year.
Conditions
Overweight, Obesity
Being tested
Semaglutide, Semaglutide Placebo
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    Participants will receive semaglutide tablets orally once daily for 44 weeks.

  • Semaglutide PlaceboDrug

    Participants will receive placebo matched to semaglutide.

Study groups in NCT05890976
Study groupRoleWhat they receive
Semaglutide 50 mgExperimentalParticipants will receive semaglutide tablets orally once daily. Participants will receive semaglutide in a dose escalation manner for 44 weeks: 3 mg (weeks 0 to 4), 7 mg (weeks 5 to 8), 14 mg (weeks 9 to 12), 25 mg (weeks 13 to 16) and 50 mg (weeks 17 to 44).
Receives: Drug: Semaglutide
Semaglutide PlaceboPlacebo comparatorParticipants will receive placebo tablets matched to semaglutide orally once daily for 44 weeks.
Receives: Drug: Semaglutide Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative Change in Body Weight

    Measured in percentage (%)

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

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

    Measured as count of participants

    Measured: At end of treatment (week 44)

Secondary outcomes (25)

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

    Measured as count of participants

    Measured: At end of treatment (week 44)

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

    Measured as count of participants

    Measured: At end of treatment (week 44)

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

    Measured as count of participants

    Measured: At end of treatment (week 44)

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

    IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score.

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

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

    IWQOL-Lite-CT is a 20-item obesity-specific PRO measure used to assess the impact of body weight changes on patient's physical and psychosocial functioning in three composite scores (Physical Function, Physical and Psychosocial) and a Total score.

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

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

    IWDAQ is a 18-item obesity-specific PRO measure developed to evaluate daily activity limitations associated with excess weight. It uses an adaptive questionnaire design where the participant chooses the three IWDAQ activities they would most like to improve with weight loss and rate the degree of limitations in each of the three activities at baseline. The same three activities are assessed for degree of limitations at follow-up to allow for tracking of activities relevant to each individual.

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

  7. Change in Body Mass Index (BMI)

    Measured in kilogram per square meter (kg/m^2)

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

  8. Change in Waist Circumference

    Measured in centimeter (cm)

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

  9. Change in Systolic Blood Pressure

    Measured in millimeter of mercury (mmHg)

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

  10. Change in Diastolic Blood Pressure

    Measured in mmHg

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

  11. Change in Glycated Haemoglobin (HbA1c)

    Measured in percentage point (%-point)

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

  12. Change in Fasting Plasma Glucose

    Measured as milligrams per decilitre (mg/dL)

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

  13. Change in Fasting Serum Insulin

    Measured as ratio to baseline

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

  14. Change in Total Cholesterol

    Measured as ratio to baseline

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

  15. Change in High-density Lipoprotein (HDL) Cholesterol

    Measured as ratio to baseline

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

  16. Change in Low-density Lipoproteins (LDL) Cholesterol

    Measured as ratio to baseline

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

  17. Change in Very Low-density Lipoproteins (VLDL) Cholesterol

    Measured as ratio to baseline

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

  18. Change in Triglycerides

    Measured as ratio to baseline

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

  19. Change in Free Fatty Acids

    Measured as ratio to baseline

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

  20. Change in High Sensitivity C-reactive Protein (hsCRP)

    Measured as ratio to baseline

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

  21. Change in waist-height ratio (WtHR)

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

  22. Number of Treatment Emergent Adverse Events(TEAE's)

    Measured as count of events

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

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

    Measured as count of events

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

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

    Measured as hours*nanomoles per litre (h*nmol/L)

    Measured: Week 20

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

    Measured as nanomoles per litre (nmol/L)

    Measured: Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2023
  2. Study start30 May 2023
  3. Primary completion16 Jan 2025
  4. Study completion16 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05890976
Sponsor's protocol ID
NN9932-4861
Other IDs
U1111-1266-2400
Acronym
OASIS 3
Status last verified
Jan 2026
First submitted
26 May 2023
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Change in Body Weight (time frame: From baseline (week 0) to end of treatment (week 44)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05890976.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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