Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

Study Overview
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Brief Summary
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This study looks at how well a new medicine, called semaglutide, works at helping people with obesity and prediabetes. This study will look at how much weight participants lose, and if participants can go from having blood sugar that is higher than normal (prediabetes) to having normal blood sugar. Semaglutide is compared to a dummy medicine. The dummy medicine looks like semaglutide but has no effect on the body. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either get semaglutide or dummy medicine - which treatment they get is decided by chance. Participants are 2 times as likely to get semaglutide as dummy medicine. 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. The study will last for about 19 months. Participants have to take the study medicine every week for the first 12 months. The last 7 months participants will not take any medication. Participants will have 14 clinic visits and 1 phone call with the study staff. At 9 of the clinic visits Participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Official Title
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Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes

Conditions
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Obesity

Intervention / Treatment
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* Drug: Semaglutide 2.4 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged greater than or equal to 18 years at the time of signing informed consent. BMI greater than or equal to 30.0 kg/m^2 Prediabetes defined as at least one of the following: HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening. FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening. Exclusion Criteria: History of type 1 or type 2 diabetes. Treatment with glucose-lowering agent(s) within 90 days before screening. HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening. FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening. A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records. Treatment with any medication for the indication of obesity within the past 90 days before 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<br>Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks | Drug: Semaglutide 2.4 mg<br>* Administered subcutaneously (s.c., under the skin) once weekly as well as reduced-calorie diet and increased physical activity for 52 weeks. Doses gradually increased to 2.4 mg<br>|
| Placebo Comparator: Placebo (semaglutide)<br>Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks | Drug: Placebo<br>* Administered subcutaneously once weekly (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 52 week<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 randomisation (week 0) to end of treatment (week 52) | 
| Change to normoglycemia (Normoglycemia is defined as having both HbA1c below 6.0% (below 42 mmol/mol) and FPG below 5.5 mmol/L (below 99 mg/dL) | Count of subjects | From randomisation (week 0) to end of treatment (week 52) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (glycated haemoglobin) | Percentage-points | From randomisation (week 0) to end of treatment (week 52) | 
| Change in FPG (fasting plasma glucose) | measured in mmol/L | From randomisation (week 0) to end of treatment (week 52) | 
| Change in waist circumference | measured in cm | From randomisation (week 0) to end of treatment (week 52) | 
| Change in systolic blood pressure | measured in mmHg | From randomisation (week 0) to end of treatment (week 52) | 
| Change in lipids - Triglycerides | percentage | From randomisation (week 0) to end of treatment (week 52) | 
| Change in lipids - Total cholesterol | percentage | From randomisation (week 0) to end of treatment (week 52) | 
| Change in lipids - High density lipoprotein (HDL) cholesterol | percentage | From randomisation (week 0) to end of treatment (week 52) | 
| Change in lipids - low density lipoprotein (LDL) cholesterol | percentage | From randomisation (week 0) to end of treatment (week 52) | 
| Change in lipids - Very low density lipoprotein (VLDL) cholesterol | percentage | From randomisation (week 0) to end of treatment (week 52) |