2024-519531-41-00招募中3 期
Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity and type 2 diabetes
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 19
- 主要终点
- Relative change in body weight.
研究概览
简要总结
To confirm superiority on body weight reduction of cagrilintide s.c. 00 mg once weekly versus placebo, as adjunct to lifestyle intervention counselling, in participants with overweight or obesity, and type 2 diabetes. To confirm superiority of cagrilintide 00 mg versus placebo on achievement of ≥ 5% weight reduction.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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.
- •Body mass index (BMI) ≥ 27.0 kg/m
- •Diagnosed with type 2 diabetes ≥ 180 days before screening.
- •Treatment with either lifestyle intervention, or: a. 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. b. For up to 30% of participants the following concomitant medication is allowed: i. 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 and/or ii. Treatment with basal insulin minimum (0.25 U/kg/day or 20 U/day) stable for at least 90 days before screening.
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.
- •Previous dosing of marketed or non-marketed amylin-based compounds.
- •Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomised according to inclusion criteria 7bi.
结局指标
主要结局
Relative change in body weight.
Relative change in body weight.
Achievement of ≥ 5% body weight reduction.
Achievement of ≥ 5% body weight reduction.
次要结局
- Change in systolic blood pressure.
- Change in diastolic blood pressure.
- Achievement of ≥ 10% body weight reduction.
- Achievement of ≥ 15% body weight reduction.
- Change in waist circumference.
- Ratio to baseline in triglycerides.
- Ratio to baseline in hsCRP.
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score.
- Change in body weight.
- Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score.
- Change in SF-36v2® mental component summary score.
- Change in IWQOL-Lite-CT total score.
- Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score.
- Ratio to baseline of: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Free fatty acids CCI CCI
- Change in glycated haemoglobin (HbA1c).
- Change in fasting plasma glucose.
- Ratio to baseline in fasting serum insulin.
- Number of treatment emergent adverse events.
- Number of treatment emergent serious adverse events.
- Number of clinically significant hypoglycaemic episodes (level 2): <3.0 mmol/L [54 mg/dL], confirmed by BG meter
- Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (19)
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