2025-524249-29-00招募中3 期
A placebo-controlled comparability study to compare two presentations 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
- 招募中
- 入组人数
- 171
- 试验地点
- 60
- 主要终点
- Relative change in body weight from baseline (week 0) to end of treatment (week 26)
研究概览
简要总结
1.To show weight-loss non-inferiority of s.c. cagrilintide D in CCI mg versus s.c. cagrilintide B in CCI mg, as adjunct to diet and physical activity counselling, in participants with overweight or obesity 2. To confirm weight loss superiority of s.c. cagrilintide D in CCI mg versus placebo, as adjunct to diet and physical activity counselling, 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
- •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.
- •Male or female (sex assigned at birth, inclusive of all gender identities).
- •Age 18 years or above at the time of signing the informed consent.
- •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 diabetes (T1D) or type 2 diabetes (T2D).
- •Previous dosing of marketed or non-marketed amylin-based compounds.
- •Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
研究组 & 干预措施
cagrilintide, cagrilintide, cagrilintide, cagrilintide
Comparator
干预措施: cagrilintide (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Relative change in body weight from baseline (week 0) to end of treatment (week 26)
Relative change in body weight from baseline (week 0) to end of treatment (week 26)
次要结局
- Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to end of study (week 33)
- Number of treatment emergent serious adverse events (TESAEs) from baseline (week 0) to end of study (week 33)
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (60)
Loading locations...
相似试验
招募中
3 期
Weight loss in people living with overweight or obesity following treatment with cagrilintide2024-519530-24-00Novo Nordisk A/S120
招募中
3 期
Weight loss in people living with overweight or obesity and type 2 diabetes following treatment with cagrilintide2024-519531-41-00Novo Nordisk A/S130
已完成
3 期
A research study to see how well CagriSema helps people with type 2 diabetes and excess body weight lose weight2023-506931-13-00Novo Nordisk A/S422
已完成
3 期
A research study to see how well different doses of CagriSema help people with excess body weight lose weightObesity2023-509273-24-00Novo Nordisk A/S100
已完成
1 期
A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body WeightObesityNCT07605052Novo Nordisk A/S50