Efficacy and Safety of Cagrilintide S.C. 2.4 mg in Combination With Semaglutide S.C. 2.4 mg (CagriSema S.C. 2.4 mg/2.4 mg) Once-Weekly in East Asian Participants With Overweight or Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 22
- 主要终点
- Relative Change in Body Weight
研究概览
简要总结
This study will look at how well the new medicine CagriSema helps people with excess body weight lose weight compared to another medicine, semaglutide. The participants will receive one injection once a week. The study medicine will be injected with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1½ 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)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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 greater than to or equal 18 years at the time of signing informed consent
- •a) Body mass index (BMI) greater than or equal to 27.0 kilograms per square meter (kg/m^2) with greater than or equal to 2 obesity-related complications or b) BMI greater than or equal to 35.0 kg/m^2 with greater than or equal to 1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D
- •Diabetes-related for participant with T2D
- •Diagnosed with T2D greater than or equal to 180 days before screening
- •HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening
- •Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors [AGI], glinides, sodium-glucose cotransporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] as a single agent or in combination) according to local label
- •Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening
排除标准
- •Obesity-related
- •- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
- •Glycaemia-related for participant without T2D
- •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
- •Diabetes-related for participant with T2D
- •Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m^2) as measured by central laboratory at screening
- •Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness
- •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 randomisation. 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
CagriSema 2.4 mg/2.4 mg
Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly (OW) after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks
干预措施: Cagrilintide (Drug)
CagriSema 2.4 mg/2.4 mg
Participants will receive 2.4 milligrams (mg) cagrilintide and 2.4 mg semaglutide subcutaneously (s.c.) once-weekly (OW) after a dose escalation period of 16 weeks (0.25 mg of cagrilintide and 0.25 mg of semaglutide from weeks 0-4, 0.5 mg of cagrilintide and 0.5 mg of semaglutide from weeks 5-8, 1 mg of cagrilintide and 1 mg of semaglutide from weeks 9-12 and 1.7 mg of cagrilintide and 1.7 mg of semaglutide from weeks 13-16) during the maintenance period for 52 weeks
干预措施: Semaglutide (Drug)
Semaglutide 2.4 mg
Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks
干预措施: Semaglutide (Drug)
Semaglutide 2.4 mg
Participants will receive semaglutide s.c. 2.4 mg and placebo matched to semaglutide OW after a dose escalation period of 16 weeks (0.25 mg for weeks 0-4, 0.5 mg for weeks 5-8, 1 mg for weeks 9-12 and 1.7 mg for weeks 13-16) during the maintenance period for 52 weeks
干预措施: Placebo Semaglutide (Drug)
结局指标
主要结局
Relative Change in Body Weight
时间窗: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%)
次要结局
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 15 Percent(From baseline (week 0) to end of treatment (week 68))
- Change in Waist Circumference Measured According to Japan Society for the Study of Obesity (JASSO) Guideline(From baseline (week 0) to end of treatment (week 68))
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 10 Percent(From baseline (week 0) to end of treatment (week 68))
- Change in Glycated Haemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 68))
- Change in Fasting Insulin(From baseline (week 0) to end of treatment (week 68))
- Change in Systolic Blood Pressure (SBP)(From baseline (week 0) to end of treatment (week 68))
- Change in Free fatty Acids(From baseline (week 0) to end of treatment (week 68))
- Change in Impact of Weight on Quality of Life-Lite for clinical trials (IWQOL-Lite-CT) Physical Function Score(From baseline (week 0) to end of treatment (week 68))
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 20 Percent(From baseline (week 0) to end of treatment (week 68))
- Change in VFA Measured by CT Scan in Subset of the Japanese Study Population(From baseline (week 0) to end of treatment (week 68))
- Relative Change in Body Weight(From baseline (week 0) to week 20)
- Change in Triglycerides(From baseline (week 0) to end of treatment (week 68))
- Change in Visceral Fat Area (VFA) Measured by CT Scan in Subset of the Japanese Study Population(From baseline (week 0) to end of treatment (week 68))
- Number of Participants Who Achieve (Yes/No): VFA lesser than 100 cm^2 (Only for Participants with VFA greater than or equal to 100 cm^2 at Baseline)(From baseline (week 0) to end of treatment (week 68))
- Number of Participants Who Achieve (Yes/No): Body Weight Reduction Greater Than or Equal to 25 Percent(From baseline (week 0) to end of treatment (week 68))
- Change in Body Weight(From baseline (week 0) to end of treatment (week 68))
- Change in Body Mass Index (BMI)(From baseline (week 0) to end of treatment (week 68))
- Change in Very Low-Density Lipoprotein (VLDL)(From baseline (week 0) to end of treatment (week 68))
- Change in Fasting Plasma Glucose (FPG)(From baseline (week 0) to end of treatment (week 68))
- Change in High-Density Lipoprotein (HDL) Cholesterol(From baseline (week 0) to end of treatment (week 68))
- Number of Treatment-Emergent Adverse Events (TEAEs)(From baseline (week 0) to end of study (week 75))
- Number of Serious Adverse Events (SAEs)(From baseline (week 0) to end of study (week 75))
- Change in Diastolic Blood Pressure (DBP)(From baseline (week 0) to end of treatment (week 68))
- Change in Total Cholesterol(From baseline (week 0) to end of treatment (week 68))
- Change in Low-Density Lipoprotein (LDL) Cholesterol(From baseline (week 0) to end of treatment (week 68))