jRCT2031220734已完成不适用
Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in East Asian participants with overweight or obesity(NN9838-4762) (REDEFINE 5)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 主要终点
- body weight reduction
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female
- •Age >=18 years at the time of signing informed consent
- •a) BMI >=27.0 kg/m2 with >=2 obesity-related complications or
- •b) BMI >=35.0 kg/m2 with >=1 obesity-related complication. At least one complication should be hypertension, dyslipidaemia or T2D.
- •Diabetes-related for participant with T2D
- •Diagnosed with T2D >= 180 days before screening
- •HbA1c 7.0-10.0%(53-86 mmol/mol))(both inclusive) as measured by central laboratory at screening
- •Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OAD)s (metformin, alfa-glucosidase inhibitors [AGI], glinides, sodium-glucose co-transporter 2 inhibitor [SGLT2i]), thiazolidinediones, or sulphonylureas [SU] as a single agent or in combination) according to local label
- •Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening.
排除标准
- •Obesity-related
- •Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
- •Glycaemia-related for participant without T2D
- •HbA1c >=6.5% (48 mmol/mol) as measured by the central laboratory at screening
- •History of type 1 or type 2 diabetes
- •Diabetes-related for participant with T2D
- •Renal impairment with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as measured by central laboratory at screening
- •Clinically significant or severe hypoglycaemia within 6 months of screening or history of hypoglycaemia unawareness
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
结局指标
主要结局
body weight reduction
To confirm superiority on body weight reduction of CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg as adjuncts to a reduced-calorie diet and increased physical activity in East Asian participants with obesity or overweight
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
1 期
A research study to see how well CagriSema helps people losing weight in people who have a body weight above the healthy range and type 2 diabetesOverweight, Obesity and Diabetes Mellitus, Type 2MedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2021-005121-24-IEovo Nordisk A/S1,200
进行中（未招募）
3 期
Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesityObesityJPRN-jRCT2051220121Oyatani Akihito250
进行中（未招募）
1 期
A research study to see how well CagriSema helps people losing weight in people who have a body weight above the healthy range and type 2 diabetesOverweight, Obesity and Diabetes Mellitus, Type 2MedDRA version: 24.1Level: PTClassification code 10033307Term: OverweightSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 20.0Level: PTClassification code 10029883Term: ObesitySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2021-005121-24-HUovo Nordisk A/S1,200
进行中（未招募）
3 期
A research study to see how well CagriSema helps people with type 2 diabetes and excess body weight lose weightCTRI/2023/04/051486ovo Nordisk AS
进行中（未招募）
3 期
A research study to see how well CagriSema helps people with excess body weight lose weightCTRI/2022/12/048201ovo Nordisk AS