NCT07220642进行中（未招募）3 期
Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 76
- 主要终点
- Relative change in body weight
研究概览
简要总结
This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 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
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
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- •Female or male (sex at birth)
- •Age 18 years or above at the time of signing the informed consent
- •History of at least one self-reported unsuccessful dietary effort to lose body weight (a*)
- •Body mass index (BMI) greater than or equal to >= 30.0 kilogram per square meter (kg/m^2), or 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 (a*)
排除标准
- •History of type 1 or type 2 diabetes (a*)
- •Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a*)
- •Previous dosing of marketed or non-marketed amylin-based compounds (a*) (a*) - As declared by the participant, reported in the medical records or at the investigator's discretion.
研究组 & 干预措施
Cagrilintide
Experimental
Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.
干预措施: Cagrilintide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.
干预措施: Placebo (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 64)
Measured as percentage (%).
Number of participants with achievement of greater than or equals (>=) 5 percent (%) body weight reduction
时间窗: From baseline (week 0) to end of treatment (week 64)
Measured as count of participants.
次要结局
- Number of participants with achievement of greater than or equal to (>=) 10 percent (%) body weight reduction (yes/no)(From baseline (week 0) to end of treatment (week 64))
- Number of participants with achievement of >= 15 % body weight reduction (yes/no)(From baseline (week 0) to end of treatment (week 64))
- Relative change in visceral abdominal fat volume(From baseline (week 0) to end of treatment (week 64))
- Number of participants with achievement of >= 5 % body weight reduction (yes/no)(From baseline (week 0) to end of treatment (week 64))
- Relative change from baseline in ectopic fat percentage: Liver fat(From baseline (week 0) to end of treatment (week 64))
- Relative change from baseline in ectopic fat percentage: Pancreatic fat(From baseline (week 0) to end of treatment (week 64))
- Relative change from baseline in ectopic fat percentage: Thigh muscle fat(From baseline (week 0) to end of treatment (week 64))
- Relative to baseline change in subcutaneous abdominal fat volume to abdominal non-fat volume(From baseline (week 0) to end of treatment (week 64))
- Relative to baseline change in visceral abdominal fat volume to abdominal non-fat volume(From baseline (week 0) to end of treatment (week 64))
- Relative to baseline change in subcutaneous fat (percent relative to total thigh volume)(From baseline (week 0) to end of treatment (week 64))
- Relative to baseline change in intramuscular fat (percent relative to total thigh volume)(From baseline (week 0) to end of treatment (week 64))
- Relative to baseline change in intermuscular fat (percent relative to total thigh volume)(From baseline (week 0) to end of treatment (week 64))
- Relative to baseline change in contractile thigh muscle (percent relative to total thigh volume)(From baseline (week 0) to end of treatment (week 64))
- Relative to baseline change in total thigh muscle volume to total thigh fat volume(From baseline (week 0) to end of treatment (week 64))
- Relative to baseline change in contractile thigh muscle volume to total thigh fat volume(From baseline (week 0) to end of treatment (week 64))
- Relative to baseline change in contractile thigh muscle volume to inter and intramuscular thigh fat volume(From baseline (week 0) to end of treatment (week 64))
- Relative change from baseline in total fat volume to total lean volume(From baseline (week 0) to end of treatment (week 64))
- Change in waist circumference(From baseline (week 0) to end of treatment (week 64))
- Number of participants with achievement of >= 10 % body weight reduction(From baseline (week 0) to end of treatment (week 64))
- Number of participants with achievement of >= 15 % body weight reduction(From baseline (week 0) to end of treatment (week 64))
- Change in body weight(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline in triglycerides(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)(From baseline (week 0) to end of treatment (week 64))
- 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 64))
- Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score(From baseline (week 0) to end of treatment (week 64))
- Change in SF-36v2® mental component summary score(From baseline (week 0) to end of treatment (week 64))
- Change in IWQOL-Lite-CT total score(From baseline (week 0) to end of treatment (week 64))
- Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT Physical Function score (yes/no)(From baseline (week 0) to end of treatment (week 64))
- Change in Systolic Blood Pressure (SBP)(From baseline (week 0) to end of treatment (week 64))
- Change in Diastolic Blood Pressure (DBP)(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline of total cholesterol(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline of High-Density Lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline of Low-Density Lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline of Very Low-Density Lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline of non-HDL cholesterol(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline of free fatty acids(From baseline (week 0) to end of treatment (week 64))
- Change in glycated haemoglobin (HbA1c) percentage-points (%-points)(From baseline (week 0) to end of treatment (week 64))
- Change in HbA1c millimoles per mole (mmol/mol)(From baseline (week 0) to end of treatment (week 64))
- Change in Fasting Plasma Glucose (FPG) millimoles per litre (mmol/L)(From baseline (week 0) to end of treatment (week 64))
- Change in FPG milligrams per deciliter (mg/dL)(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline in fasting serum insulin(From baseline (week 0) to end of treatment (week 64))
- Number of treatment emergent adverse events (TEAEs)(From baseline (week 0) to end of study (week 71))
- Number of treatment emergent serious adverse events (TESAEs)(From baseline (week 0) to end of study (week 71))
研究者
研究点 (76)
Loading locations...
相似试验
已完成
3 期
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose WeightObesityNCT06388187Novo Nordisk A/S300
已完成
3 期
A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose WeightObesity or OverweightNCT05813925Novo Nordisk A/S331
已完成
3 期
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose WeightObesity or OverweightNCT05996848Novo Nordisk A/S300
进行中（未招募）
3 期
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With ObesityObesityNCT06780449Novo Nordisk A/S400
已完成
3 期
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose WeightOverweightObesityType 2 Diabetes MellitusNCT05394519Novo Nordisk A/S1,200