Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,400
- 试验地点
- 250
- 主要终点
- CagriSema versus placebo: Relative change in body weight
研究概览
简要总结
This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms.
Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 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
- 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
- •Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
排除标准
- •- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus
研究组 & 干预措施
Placebo s.c.
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.
干预措施: Placebo cagrilintide (Drug)
Cagrisema
Participants will receive cagrilintide and semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.
干预措施: Cagrilintide (Drug)
Semaglutide
Participants will receive semaglutide s.c.and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.
干预措施: Placebo cagrilintide (Drug)
Semaglutide
Participants will receive semaglutide s.c.and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.
干预措施: Semaglutide (Drug)
Cagrisema
Participants will receive cagrilintide and semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.
干预措施: Semaglutide (Drug)
Cagrilintide
Participants will receive cagrilintide s.c. and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.
干预措施: Placebo semaglutide (Drug)
Cagrilintide
Participants will receive cagrilintide s.c. and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.
干预措施: Cagrilintide (Drug)
Placebo s.c.
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.
干预措施: Placebo semaglutide (Drug)
结局指标
主要结局
CagriSema versus placebo: Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%)
CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction
时间窗: From baseline (week 0) to end of treatment (week 68)
Measured as count of participants
次要结局
- CagriSema versus placebo: Achievement of >= 25% weight reduction(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Achievement of >= 30% weight reduction(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus semaglutide and cagrilintide: Change in SBP(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Ratio to baseline in Free fatty acids(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus semaglutide and cagrilintide: Ratio to baseline in total cholesterol(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus semaglutide and cagrilintide: Ratio to baseline in VLDL(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Relative change in body weight (Measured in kilograms (kg))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Relative change in body weight (Measured in percentage (%))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as kilograms (kg))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as %-points)(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in percentage (%))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in percentage (%))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in IWQOL-Lite-CT - Physical Function Score(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in IWQOL-Lite-CT - Psychosocial Score(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Achievement of at least 14.6- point increase (yes/no) in IWQOL-Lite-CT Physical Function score(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in IWQOL-Lite-CT - Total Score(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo, semaglutide and cagrilintide: Change in body weight(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo, semalutide and cagrilintide: Change in body mass index (BMI)(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo, semaglutide and cagrilintide: Improvement in weight category(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in Glycated Haemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in HbA1c(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in Fasting Plasma Glucose (FPG) (mmol/L).(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in FPG (mg/dL)(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Achievement of >= 20% weight reduction(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Ratio to baseline in fasting serum insulin(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Relative change in body weight(From baseline (week 0) to week 20)
- CagriSema versus placebo: Change in waist circumference(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in Diastolic Blood Pressure (DBP)(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in systolic blood pressure (SBP)(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Ratio to baseline in total cholesterol(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Ratio to baseline in Triglycerides(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus semaglutide and cagrilintide: Change in waist circumference(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus semaglutide and cagrilintide: Ratio to baseline in HDL(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus semaglutide and cagrilintide: Ratio to baseline in LDL(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Triglycerides(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Free fatty acids(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Absolute change in body weight (Measured in kilograms (kg))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Absolute change in body weight (Measured in percentage (%))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as percentage (%))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as kilograms (kg))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as percentage (%))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as percentage (%))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as percentage (%))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as %-points)(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in kilograms (kg))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in kilograms (kg))(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score(From baseline (week 0) to end of treatment (week 68))
- Change in Control of Eating (COEQ): Craving Control Score(From baseline (week 0) to end of treatment (week 68))
- Change in COEQ: Craving for Savoury food score(From baseline (week 0) to end of treatment (week 68))
- Change in COEQ: Hunger score(From baseline (week 0) to end of treatment (week 68))
- Change in COEQ: Craving for Sweets Score(From baseline (week 0) to end of treatment (week 68))
- Change in COEQ: Positive Mood score(From baseline (week 0) to end of treatment (week 68))
- Change in COEQ: Satiety score(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Change in IWQOL-Lite-CT Physical Function score(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score(From baseline (week 0) to end of treatment (week 68))
- CagriSema versus placebo, semalutide and cagrilintide: Ratio to baseline C-reactive protein (CRP)(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-main part (week 75))
- Number of Treatment Emergent Serious adverse events (TESAEs)(From baseline (week 0) to end of study-main part (week 75))
- CagriSema versus placebo: Relative change in body weight(From baseline (week 0) to week 8)