2023-509273-24-00已完成3 期
Efficacy and safety of cagrilintide s.c. in combination with semaglutide s.c. (CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) once-weekly in participants with overweight or obesity
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Achievement of ≥5% weight reduction
研究概览
简要总结
To confirm superiority on body weight reduction of CagriSema 00 mg/00 mg and CagriSema 00 mg/00 mg versus placebo as an adjunct to reduced-calorie diet and increased physical activity in participants with overweight or obesity.
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
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
- •a) BMI ≥30.0 kg/m2a or b) BMI ≥27.0 kg/m2a with the presence of at least one obesity-related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
排除标准
- •HbA1c ≥6.5% (48 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
cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide
Test
干预措施: cagrilintide semaglutide (Drug)
Placebo + Placebo
Placebo
干预措施: Placebo + Placebo (Drug)
结局指标
主要结局
Achievement of ≥5% weight reduction
Achievement of ≥5% weight reduction
Relative change in body weight
Relative change in body weight
次要结局
- Achievement of ≥10 % weight reduction
- Achievement of ≥15% weight reduction
- Achievement of ≥20% weight reduction
- Change in waist circumference
- Change in systolic blood pressure
- Ratio to baselin in lipids: Total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, Triglycerids, Free fatty acids
研究者
EU submission Hub
Scientific
Novo Nordisk A/S
研究点 (8)
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