NCT07220759进行中（未招募）3 期
Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes
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
- 330
- 试验地点
- 67
- 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 and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant 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. 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) >= 27.0 kilogram per square meter (kg/m^2).
- •Diagnosed with type 2 diabetes >= 180 days before screening.(a*)
- •Treatment with either lifestyle intervention(a*), or:
- •Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a*)
- •For up to 30% of participants the following concomitant medication is allowed:
- •Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a*) and/or
- •Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day [U/day]) stable for at least 90 days before screening.(a*)
排除标准
- •Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a*)
- •Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomized according to inclusion criteria 7bi.(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
Placebo
Placebo Comparator
Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.
干预措施: Placebo (matched to Cagrilintide) (Drug)
Cagrilintide
Experimental
Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.
干预措施: Cagrilintide (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 (%) of body weight.
次要结局
- Number of participants with achievement of >= 10% 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))
- Change in glycated haemoglobin (HbA1c)(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))
- Number of participants with 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 64))
- Ratio to baseline in lipids: free fatty acids(From baseline (week 0) to end of treatment (week 64))
- Change in fasting plasma glucose (FPG) in millimole per liter (mmol/L)(From baseline (week 0) to end of treatment (week 64))
- Change in FPG in milligram 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(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))
- Number of clinically significant hypoglycaemic episodes (level 2):<3.0 mmol/L [54 mg/dL], confirmed by blood glucose meter(From baseline (week 0) to end of study (week 71))
- Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold(From baseline (week 0) to end of study (week 71))
- Change in waist circumference(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline in lipids: 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 body weight(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))
- 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 in lipids: total cholesterol(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline in lipids: high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 64))
- Ratio to baseline in lipids: non-HDL cholesterol(From baseline (week 0) to end of treatment (week 64))
研究者
研究点 (67)
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