Effect and Safety of Semaglutide 7.2 mg Once-weekly in Participants With Obesity and Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 512
- 试验地点
- 131
- 主要终点
- Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)
研究概览
简要总结
This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years
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.
- •Age above or equal to 18 years at the time of signing informed consent.
- •BMI greater than or equal to 30.0 kilograms per square meter (kg/m^2).
- •Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
- •HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening.
排除标准
- •A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds [lbs]) within 90 days before screening irrespective of medical records.
- •Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m^2) (less than 45 mL/min/1.73 m^2 in participants treated with Sodium-glucose Cotransporter-2 [SGLT2i]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening.
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
研究组 & 干预措施
Placebo
Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks.
干预措施: Placebo (Drug)
Semaglutide 7.2 mg
Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram [mg], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72.
干预措施: Semaglutide (Drug)
Semaglutide 2.4 mg
Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no)
时间窗: From baseline (week 0) to end of treatment (week 72)
Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 72)
Measured in percentage (%).
Relative Change in Body Weight
时间窗: Baseline (week 0), End of treatment (week 72)
Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented.
Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no)
时间窗: At week 72
Number of participants who achieve body weight reduction \>=5% is presented. Yes defines participants who achieved body weight reduction \>= 5% and No defines participants who did not achieve body weight reduction \>=5%.
次要结局
- Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in body weight(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in triglycerides(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than or equal to (<=) 6.5 % (48 mmol/mol)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in waist circumference(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in total cholesterol(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in very-low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs)(From baseline (week 0) to end of study (week 81))
- Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs)(From baseline (week 0) to end of study (week 81))
- Semaglutide 7.2 mg versus Placebo: Change in pulse(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes(From baseline (week 0) to end of study (week 81))
- Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes(From baseline (week 0) to end of study (week 81))
- Semaglutide 7.2 mg versus Placebo: Change in free fatty acids(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP)(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than (<) 7.0% (53 millimoles per mole [mmol/mol])(From baseline (week 0) to end of treatment (week 72))
- Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs(From baseline (week 0) to end of study (week 81))
- Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs(From baseline (week 0) to end of study (week 81))
- Number of Participants Who Achieve Body Weight Reduction >= 10% (Yes/no)(At week 72)
- Number of Participants Who Achieve Body Weight Reduction >= 15% (Yes/no)(At week 72)
- Number of Participants Who Achieve Body Weight Reduction >= 20% (Yes/no)(At week 72)
- Change in Waist Circumference(Baseline (week 0), End of treatment (week 72))
- Change in Glycated Haemoglobin (HbA1c)(Baseline (week 0), End of treatment (week 72))
- Change in Body Weight(Baseline (week 0), End of treatment (week 72))
- Change in Body Mass Index (BMI)(Baseline (week 0), End of treatment (week 72))
- Change in Systolic Blood Pressure(Baseline (week 0), End of treatment (week 72))
- Change in Diastolic Blood Pressure(Baseline (week 0), End of treatment (week 72))
- Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in Total Cholesterol (Milligrams Per Deciliter [mg/dL]) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in HDL Cholesterol (mg/dL) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in LDL Cholesterol (mg/dL) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in Very-low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in VLDL Cholesterol (mg/dL) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in Triglycerides (mmol/L) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in Triglycerides (mg/dL) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in Free Fatty Acids (mmol/L) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in Free Fatty Acids (mg/dL) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in Fasting Plasma Glucose(Baseline (week 0), End of treatment (week 72))
- Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline(Baseline (week 0), End of treatment (week 72))
- Number of Participants With HbA1c Less Than 7.0 % (53 Millimoles Per Mole [mmol/Mol])(At week 72)
- Number of Participants With HbA1c Less Than or Equal to 6.5% (48 mmol/Mol)(At week 72)
- Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs)(At week 81)
- Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs)(At week 81)
- Change in Pulse(Baseline (week 0), End of treatment (week 72))
- Semaglutide 7.2 mg Versus Placebo: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes(At week 81)
- Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs(At week 81)
- Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs(At week 81)
- Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes(At week 81)