Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 72
- 主要终点
- Change in Body Weight (Percentage [%])
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Semaglutide
Participants will receive subcutaneus (s.c.) semaglutide 2.4 mg once weekly for 52 weeks
干预措施: Semaglutide 2.4 mg (Drug)
Placebo (semaglutide)
Participants will receive subcutaneus (s.c.) placebo (semaglutide) once weekly for 52 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Body Weight (Percentage [%])
时间窗: From randomisation (week 0) to end of treatment (week 52)
Change in body weight from randomisation (week 0) to end of treatment (week 52) is presented. The endpoint was evaluated based on the data from in-trial observation period which was defined as the time period where the participant was assessed in the main phase of the study. The 'in-trial' (main phase) observation period for a participant begins on the date of randomisation and ends at the first of the following dates (both inclusive): safety visit, withdrawal of consent, last contact with participant (for participants lost to follow-up), death.
Participants With Change to Normoglycemia
时间窗: At week 52
Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes" at Week 52 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: glycosylated haemoglobin (HbA1c) lesser than (\<) 6.0 percentage (%) and fasting plasma glucose (FPG) lesser than (\<) 5.5 millimoles per liter (mmol/L). 2) Pre-diabetes: 6.0% lesser than or equal (≤) HbA1c lesser than (\<) 6.5% or 5.5 mmol/L lesser than or equal (≤) FPG lesser than (\<) 7.0 mmol/L or non-verified type 2 diabetes. 3) Type 2 diabetes: HbA1c greater than or equal (≥) 6.5% or FPG greater than or equal (≥) 7.0 mmol/L.
次要结局
- Change in Glycosylated Haemoglobin (HbA1c)(From randomisation (week 0) to end of treatment (week 52))
- Change in Fasting Plasma Glucose (FPG)(From randomisation (week 0) to end of treatment (week 52))
- Change in Waist Circumference(From randomisation (week 0) to end of treatment (week 52))
- Change in Systolic Blood Pressure(From randomisation (week 0) to end of treatment (week 52))
- Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline(From randomisation (week 0) to end of treatment (week 52))
- Change in Total Cholesterol (mmol/L) - Ratio to Baseline(From randomisation (week 0) to end of treatment (week 52))
- Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline(From randomisation (week 0) to end of treatment (week 52))
- Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline(From randomisation (week 0) to end of treatment (week 52))
- Change in Very Low Density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline(From randomisation (week 0) to end of treatment (week 52))
- Change in Body Weight (Kilogram [Kg])(From randomisation (week 0) to week 52)
- Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)(At week 52)
- Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)(At week 52)
- Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)(At week 52)
- Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)(At week 52)
- Change in Pulse(From randomisation (week 0) to end of treatment (week 52))