2024-519530-24-00招募中3 期
Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 16
- 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. 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（18-64 Years, 65+ 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) ≥ 30.0 kg/m2, or BMI ≥ 27.0 kg/m2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
排除标准
- •History of type 1 or type 2 diabetes.
- •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.
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
- 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.
- Change in systolic blood pressure.
- Change in diastolic blood pressure.
- 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.
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (16)
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