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Completed

NCT Number: NCT05890976

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Friendship Hospital, Capital Medical University-Endocrinology, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

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.

Treatment and study plan

semaglutide

Drug

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

Semaglutide Placebo

Drug

Participants will receive placebo matched to semaglutide.

Primary outcomes

  1. Relative Change in Body Weight

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

    Measured in percentage (%)

  2. 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)

    Measured as count of participants

Secondary outcomes

  1. 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)

    Measured as count of participants

  2. 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)

    Measured as count of participants

  3. 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)

    Measured as count of participants

  4. 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-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.

  5. 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-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.

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

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

    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.

  7. Change in Body Mass Index (BMI)

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

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

  8. Change in Waist Circumference

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

    Measured in centimeter (cm)

  9. Change in Systolic Blood Pressure

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

    Measured in millimeter of mercury (mmHg)

  10. Change in Diastolic Blood Pressure

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

    Measured in mmHg

  11. Change in Glycated Haemoglobin (HbA1c)

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

    Measured in percentage point (%-point)

  12. Change in Fasting Plasma Glucose

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

    Measured as milligrams per decilitre (mg/dL)

  13. Change in Fasting Serum Insulin

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

    Measured as ratio to baseline

  14. Change in Total Cholesterol

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

    Measured as ratio to baseline

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

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

    Measured as ratio to baseline

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

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

    Measured as ratio to baseline

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

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

    Measured as ratio to baseline

  18. Change in Triglycerides

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

    Measured as ratio to baseline

  19. Change in Free Fatty Acids

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

    Measured as ratio to baseline

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

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

    Measured as ratio to baseline

  21. Change in waist-height ratio (WtHR)

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

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

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

    Measured as count of events

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

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

    Measured as count of events

  24. 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

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

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

    Time frame: Week 20

    Measured as nanomoles per litre (nmol/L)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: OASIS 3

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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