Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 36
- 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 with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.
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.
- •Body mass index (BMI) greater than or equal to (>=) 35.0 kilograms per meter square (kg/m^2).
排除标准
- •Glycated haemoglobin (HbA1c) >= 6.5 percent (48 millimoles 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 once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year.
干预措施: Cagrilintide (Drug)
CagriSema
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) after a dose escalation period of 16 weeks during the maintenance period for 88 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for one year.
干预措施: Semaglutide (Drug)
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year.
干预措施: Placebo cagrilintide (Drug)
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously once weekly for 104 weeks. Participants randomised to this arm will be included in the extension phase for one year.
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 week 104
Measured in percentage (%).
次要结局
- Number of participants who achieve greater than or equal to (>=) 20 percent body weight reduction(From baseline (week 0) to week 104)
- Number of participants who achieve >= 25 percent body weight reduction(From baseline (week 0) to week 104)
- Number of participants who achieve >= 30 percent body weight reduction(From baseline (week 0) to week 104)
- Change in waist circumference(From baseline (week 0) to week 104)
- Change in waist to height ratio(From baseline (week 0) to week 104)
- Change in Systolic Blood Pressure (SBP)(From baseline (week 0) to week 104)
- Ratio to Baseline in Lipids: Total Cholesterol(From baseline (week 0) to week 104)
- Ratio to Baseline in Lipids: High Density Lipoprotein (HDL) Cholesterol(From baseline (week 0) to week 104)
- Ratio to Baseline in Lipids: Low Density Lipoprotein (LDL) Cholesterol(From baseline (week 0) to week 104)
- Ratio to Baseline in Lipids: Very Low Density Lipoprotein (VLDL) Cholesterol(From baseline (week 0) to week 104)
- Ratio to Baseline in Lipids: Triglycerides(From baseline (week 0) to week 104)
- Ratio to Baseline in Lipids: Free fatty acids(From baseline (week 0) to week 104)
- Ratio to Baseline in Lipids: Non-HDL cholesterol(From baseline (week 0) to week 104)
- Change in Body Mass Index (BMI)(From baseline (week 0) to week 104)
- Number of participants who achieve BMI less than 30 kg/m^2(At week 104)
- Change in Glycated Haemoglobin (HbA1c) (percentage points)(From baseline (week 0) to week 104)
- Change in HbA1c (millimoles per mole [mmol/mol])(From baseline (week 0) to week 104)
- Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])(From baseline (week 0) to week 104)
- Change in FPG (milligrams per deciliter [mg/dL])(From baseline (week 0) to week 104)
- Number of participants who achieve HbA1c less than (<) 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline(From baseline (week 0) to week 104)
- Number of participants who achieve HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline(From baseline (week 0) to week 104)
- Time to HbA1c < 5.7 percent and FPG < 100 mg/dL with prediabetes at baseline(From baseline (week 0) to week 104)
- Time to HbA1c >= 6.5 percent or FPG >= 126 mg/dL with prediabetes at baseline(From baseline (week 0) to week 104)
- Number of participants who develop HbA1c >= 5.7 percent or FPG greater than (>) 100 mg/dL with normoglycemia at baseline(From baseline (week 0) to week 104)
- Number of participants who develop type 2 diabetes (T2D) as per American Diabetes Association (ADA) guideline(From baseline (week 0) to week 104)
- Time to T2D diagnosis as per ADA guideline(From baseline (week 0) to week 104)
- Change in American College of Cardiology/American Heart Association (ACC/AHA) 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk score(From baseline (week 0) to week 104)
- Number of participants who improve in >= 1 pre-existing cardiometabolic obesity related com-plication (ORC) (hypertension, prediabetes, or dyslipidaemia)(From baseline (week 0) to week 104)
- Ratio to baseline in C-reactive protein (CRP)(From baseline (week 0) to week 104)
- Change in total fat mass by dual energy X-ray absorption (DXA) absolute to total body mass (kilogram [kg])(From baseline (week 0) to week 104)
- Change in total fat mass by DXA relative to total body mass (kg)(From baseline (week 0) to week 104)
- Change in total fat mass by DXA absolute to total body mass (percentage points)(From baseline (week 0) to week 104)
- Change in total fat mass by DXA relative to total body mass (percentage points)(From baseline (week 0) to week 104)
- Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage)(From baseline (week 0) to week 104)
- Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage)(From baseline (week 0) to week 104)
- Change in visceral fat mass by DXA, relative to baseline in visceral fat mass region (percentage points)(From baseline (week 0) to week 104)
- Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (percentage points)(From baseline (week 0) to week 104)
- Change in lean body mass by DXA absolute to total body mass (kg)(From baseline (week 0) to week 104)
- Change in lean body mass by DXA relative to total body mass (kg)(From baseline (week 0) to week 104)
- Change in lean body mass by DXA absolute to total body mass (percentage points)(From baseline (week 0) to week 104)
- Change in lean body mass by DXA relative to total body mass (percentage points)(From baseline (week 0) to week 104)
- Change in Short Form (SF)-36 Physical functioning score(From baseline (week 0) to week 104)
- 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 104)
- Change in IWQOL-Lite-CT: Physical Score(From baseline (week 0) to week 104)
- Change in IWQOL-Lite-CT: Psychosocial score(From baseline (week 0) to week 104)
- Change in IWQOL-Lite-CT: Total score(From baseline (week 0) to week 104)
- CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Serious Adverse Events (TESAEs)(From baseline (week 0) to week 104)
- CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TEAEs(From week 104 to end of study (week 162))
- Change in Impact of Weight on Daily Activities Questionnaire (IWDAQ) Composite score(From baseline (week 0) to week 104)
- Change in Control of Eating questionnaire (CoEQ): Craving Control score(From baseline (week 0) to week 104)
- Change in CoEQ: Positive Mood score(From baseline (week 0) to week 104)
- Change in CoEQ: Craving for Sweets score(From baseline (week 0) to week 104)
- Change in CoEQ: Craving for Savoury score(From baseline (week 0) to week 104)
- Change in CoEQ: Hunger score(From baseline (week 0) to week 104)
- Change in CoEQ: Satiety score(From baseline (week 0) to week 104)
- CagriSema s.c. 2.4 mg/2.4 mg versus placebo: Number of Treatment Emergent Adverse Events (TEAEs)(From baseline (week 0) to week 104)
- CagriSema s.c. 2.4 mg/2.4 mg versus CagriSema s.c. dose tapering algorithm: Number of TESAEs(From week 104 to end of study (week 162))
- CagriSema 2.4 mg/2.4 mg: Number of TEAEs(From week 104 to end of study (week 162))
- CagriSema 2.4 mg/2.4 mg: Number of TESAEs(From week 104 to end of study (week 162))