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

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Drug: Semaglutide
* Drug: Semaglutide Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semaglutide 50 mg<br>Participants 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). | Drug: Semaglutide<br>* Participants will receive semaglutide tablets orally once daily for 44 weeks.<br>|
| Placebo Comparator: Semaglutide Placebo<br>Participants will receive placebo tablets matched to semaglutide orally once daily for 44 weeks. | Drug: Semaglutide Placebo<br>* Participants will receive placebo matched to semaglutide.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Change in Body Weight | Measured in percentage (%) | From baseline (week 0) to end of treatment (week 44) | 
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 5 Percent | Measured as count of participants | At end of treatment (week 44) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent | Measured as count of participants | At end of treatment (week 44) | 
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent | Measured as count of participants | At end of treatment (week 44) | 
| Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent | Measured as count of participants | At end of treatment (week 44) | 
| 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. | From baseline (week 0) to end of treatment (week 44) | 
| 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. | From baseline (week 0) to end of treatment (week 44) | 
| Change in Impact of Weight on Daily Activities Quesionnaire (IWDAQ) | 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. | From randomisation (week 0) to end-of-treatment (week 44) | 
| Change in Body Mass Index (BMI) | Measured in kilogram per square meter (kg/m^2) | From baseline (week 0) to end of treatment (week 44) | 
| Change in Waist Circumference | Measured in centimeter (cm) | From baseline (week 0) to end of treatment (week 44) | 
| Change in Systolic Blood Pressure | Measured in millimeter of mercury (mmHg) | From baseline (week 0) to end of treatment (week 44) | 
| Change in Diastolic Blood Pressure | Measured in mmHg | From randomisation (week 0) to end of treatment (week 44) | 
| Change in Glycated Haemoglobin (HbA1c) | Measured in percentage point (%-point) | From baseline (week 0) to end of treatment (week 44) | 
| Change in Fasting Plasma Glucose | Measured as milligrams per decilitre (mg/dL) | From baseline (week 0) to end of treatment (week 44) | 
| Change in Fasting Serum Insulin | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) | 
| Change in Total Cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) | 
| Change in High-density Lipoprotein (HDL) Cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) | 
| Change in Low-density Lipoproteins (LDL) Cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) | 
| Change in Very Low-density Lipoproteins (VLDL) Cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) | 
| Change in Triglycerides | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) | 
| Change in Free Fatty Acids | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) | 
| Change in High Sensitivity C-reactive Protein (hsCRP) | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 44) | 
| Number of Treatment Emergent Adverse Events(TEAE's) | Measured as count of events | From baseline (week 0) to end of treatment (week 44) | 
| Number of Treatment Emergent Serious Adverse Events(TESAE's) | Measured as count of events | From baseline (week 0) to end of study (week 51) | 
| 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) | Week 20 | 
| Cmax,sema,50mg,ss: Maximum Concentration at Steady State of Semaglutide 50 mg | Measured as nanomoles per litre (nmol/L) | Week 20 |