Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity

Study Overview
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Brief Summary
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This study looks at how well semaglutide helps people lose weight. This study will look at the change in the participants' body weight from the start to the end of the study. The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo. Placebo is a dummy medicine that looks like the study medicine, but has no effect on the body. Participants will either get semaglutide or dummy medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. Participants will also have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. The study will last for about a year (50 weeks). Participants will have 10 clinic visits and 8 phone calls. At 6 of the clinic visits participants will have blood samples taken. At 3 of the clinic visits participants cannot eat and drink (water is allowed) for 8 hours before the visit. Participants cannot take part if participants have or have had diabetes. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Official Title
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Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Asians With Obesity Diagnosed as BMI ≥ 25 kg/m2 According to Local Guidelines

Conditions
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Obesity

Intervention / Treatment
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* Drug: Semaglutide 2.4 mg
* Drug: Placebo (semaglutide 2.4 mg)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above or equal to 18 years at the time of signing informed consent. BMI at least 25.0 kg/m^2 at screening. Both parents of Asian descent. History of at least one self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria: HbA1c at least 48 mmol/mol (6.5%) as measured by the central laboratory at screening. History of type 1 or type 2 diabetes mellitus. A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records. Any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety. Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 15 mL/min/1.73 m^2 at screening.
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 2.4 mg<br> | Drug: Semaglutide 2.4 mg<br>* Administered subcutaneously (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 44 weeks. Doses gradually increased to 2.4 mg<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo (semaglutide 2.4 mg)<br>* Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Percentage | From baseline (week 0) to end of treatment (week 44) | 
| At least 5% body weight reduction (yes/no) | Count of participant | From baseline (week 0) to end of treatment (week 44) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At least 10% body weight reduction (yes/no) | Count of participant | From baseline (week 0) to end of treatment (week 44) | 
| At least 15% body weight reduction (yes/no) | Count of participant | From baseline (week 0) to end of treatment (week 44) | 
| Change in waist circumference | cm | From baseline (week 0) to end of treatment (week 44) | 
| At least 20% body weight reduction (yes/no) | Count of participant | From baseline (week 0) to end of treatment (week 44) | 
| Change in body weight | kg | From baseline (week 0) to end of treatment (week 44) | 
| Change in body mass index | kg/m^2 | From baseline (week 0) to end of treatment (week 44) | 
| Change in systolic blood pressure | mmHg | From baseline (week 0) to end of treatment (week 44) | 
| Change in diastolic blood pressure | mmHg | From baseline (week 0) to end of treatment (week 44) | 
| Change in total cholesterol | mg/dL | From baseline (week 0) to end of treatment (week 44) | 
| Change in total cholesterol | mmol/L | From baseline (week 0) to end of treatment (week 44) | 
| Change in high-density lipoprotein (HDL) cholesterol | mg/dL | From baseline (week 0) to end of treatment (week 44) | 
| Change in high-density lipoprotein (HDL) cholesterol | mmol/L | From baseline (week 0) to end of treatment (week 44) | 
| Change in low-density lipoprotein (LDL) cholesterol | mg/dL | From baseline (week 0) to end of treatment (week 44) | 
| Change in low-density lipoprotein (LDL) cholesterol | mmol/L | From baseline (week 0) to end of treatment (week 44) | 
| Change in triglycerides | mg/dL | From baseline (week 0) to end of treatment (week 44) | 
| Change in triglycerides | mmol/L | From baseline (week 0) to end of treatment (week 44) | 
| Change in high-sensitivity c-reactive protein (hsCRP) | mg/L | From baseline (week 0) to end of treatment (week 44) |