Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c. (CagriSema s.c.) Once Weekly for Weight Management and Long-term Weight Maintenance in Participants With Obesity
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 609
- 试验地点
- 47
- 主要终点
- Relative change in body weight
研究概览
简要总结
This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.
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
Participants in the main phase will be randomised in double blinded manner to receive either CagriSema or matching placebo. In the extension phase, eligible participants will be re-randomised and enter the open label extension phase. 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 (sex at birth).
- •Age 18 years or above at the time of signing the informed consent.
- •BMI ≥ 30.0 kilogram per square meter (kg/m^2) at screening.
- •Participant has a wish to lose at least 25% of body weight within 80 weeks from randomisation.
排除标准
- •Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening.
- •History of type 1 or type 2 diabetes.
研究组 & 干预措施
CagriSema
Participants will receive CagriSema subcutaneously once weekly in a dose escalation manner (dose increases every 4 weeks) for up to 16 weeks followed by CagriSema maintenance dose subcutaneously once weekly for 64 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive 1 of the 3 dose levels of CagriSema for 80 weeks.
干预措施: CagriSema (Cagrilintide B and Semaglutide I) (Drug)
Placebo
Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks.
干预措施: CagriSema (Cagrilintide B and Semaglutide I) (Drug)
Placebo
Participants will receive placebo matched to CagriSema subcutaneously once weekly for 80 weeks in the main phase of the study. Participants randomised to this arm will be included in the extension phase to receive CagriSema with flexible dose escalation for 80 weeks.
干预措施: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I) (Drug)
结局指标
主要结局
Relative change in body weight
时间窗: From baseline (week 0) to week 80
Measured as percentage change.
次要结局
- Ratio to baseline in lipids: HDL(From baseline (week 0) to week 80)
- Number of participants who achieve ≥ 15% weight reduction(From baseline (week 0) to week 80)
- Relative change in body weight in women(From baseline (week 0) to week 80)
- Number of participants who achieve ≥ 30% weight reduction(From baseline (week 0) to week 80)
- Number of participants who achieve normal body mass index (BMI) (18.5 kilograms per meter square (kg/m^2) less than or equal to (≤ ) BMI < 25 kg/m^2)(From baseline (week 0) to week 80)
- Number of participants who achieve BMI < 30 kg/m^2(From baseline (week 0) to week 80)
- Change in waist circumference(From baseline (week 0) to week 80)
- Change in systolic blood pressure(From baseline (week 0) to week 80)
- Ratio to baseline in C-reactive protein (CRP)(From baseline (week 0) to week 80)
- Ratio to baseline in lipids: non-high density lipoprotein (HDL) cholesterol(From baseline (week 0) to week 80)
- Ratio to baseline in lipids: triglycerides(From baseline (week 0) to week 80)
- Change in impact of weight on quality of life-lite for clinical trials (IWQOL-Lite-CT) physical function score(From baseline (week 0) to week 80)
- Change in short form (SF)-36v2 physical function(From baseline (week 0) to week 80)
- Change in IWQOL-Lite-CT physical function for subgroup with poor physical functioning at baseline (according to patient global impression of status [PGI-S])(From baseline (week 0) to week 80)
- Change in SF-36v2 physical function for subgroup with poor physical functioning at baseline (according to PGI-S)(From baseline (week 0) to week 80)
- Number of participants who achieve ≥ 5% weight reduction(From baseline (week 0) to week 80)
- Number of participants who achieve ≥ 10% weight reduction(From baseline (week 0) to week 80)
- Change in waist to height ratio(From baseline (week 0) to week 80)
- Change in waist to hip ratio(From baseline (week 0) to week 80)
- Number of participants with reduction in weight category(From baseline (week 0) to week 80)
- Change in diastolic blood pressure(From baseline (week 0) to week 80)
- Ratio to baseline in lipids: total cholesterol(From baseline (week 0) to week 80)
- Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to week 80)
- Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to week 80)
- Ratio to baseline in lipids: free fatty acids(From baseline (week 0) to week 80)
- Change in control of eating questionnaire (CoEQ): craving control score(From baseline (week 0) to week 80)
- Change in CoEQ: positive mood score(From baseline (week 0) to week 80)
- Change in CoEQ: craving for sweets score(From baseline (week 0) to week 80)
- Change in CoEQ: craving for savoury score(From baseline (week 0) to week 80)
- Change in CoEQ: hunger score(From baseline (week 0) to week 80)
- Change in CoEQ: satiety score(From baseline (week 0) to week 80)
- Change in IWQOL-Lite-CT: physical score(From baseline (week 0) to week 80)
- Change in IWQOL-Lite-CT: psychosocial score(From baseline (week 0) to week 80)
- Change in IWQOL-Lite-CT: total score(From baseline (week 0) to week 80)
- Change in SF-36v2 health survey acute: physical component summary score(From baseline (week 0) to week 80)
- Change in SF-36v2 health survey acute: mental component summary(From baseline (week 0) to week 80)
- Number of treatment emergent adverse events (TEAEs)(From baseline (week 0) to week 80)
- Number of treatment emergent serious adverse events (TESAEs)(From baseline (week 0) to week 80)
- Number of participants who achieve greater than or equals (≥) 20% weight reduction(From baseline (week 0) to week 80)
- Number of participants who achieve ≥ 25% weight reduction(From baseline (week 0) to week 80)