NCT07564414招募中3 期
A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes
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
- 2,500
- 试验地点
- 539
- 主要终点
- Relative change in body weight
研究概览
简要总结
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •BMI≥ 35.0 kg/m^
- •Participants without T2D: No history of T2D and HbA1c < 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.
排除标准
- •A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records.
- •Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.
研究组 & 干预措施
Semaglutide
Active Comparator
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.
干预措施: Semaglutide (Drug)
Cagrisema - dose level 1
Experimental
Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.
干预措施: Cagrisema (Drug)
Cagrisema - dose level 2
Active Comparator
Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.
干预措施: Cagrisema (Drug)
结局指标
主要结局
Relative change in body weight
时间窗: From randomisation (week 0) to end of treatment (week 72)
Measured as percentage (%).
次要结局
- Relative change in body weight(From randomisation (week 0) to end of treatment (week 72))
- Change in Body Mass Index (BMI)(From randomisation (week 0) to end of treatment (week 72))
- Number of participants who achieve greater than or equal to (≥) 30% weight reduction(From randomisation (week 0) to end of treatment (week 72))
- Number of participants who achieve ≥25% weight reduction(From randomisation (week 0) to end of treatment (week 72))
- Number of participants who achieve greater ≥ 20% weight reduction(From randomisation (week 0) to end of treatment (week 72))
- Change in waist circumference(From randomisation (week 0) to end of treatment (week 72))
- Mean change in body weight(From randomisation (week 0) to end of treatment (week 72))
- Number of participants who achieve a BMI less than (<) 30 kg/m^2(From randomisation (week 0) to end of treatment (week 72))
- Number of participants who achieve BMI <27 kg/m^2(end of treatment (week 72))
- Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2(At end of treatment (week 72))
- Number of participants who achieve a waist-to-height ratio < 0.53(At end of treatment (week 72))
- Ratio to baseline : Total cholesterol(From baseline (week 0) to end of treatment (week 72))
- Ratio to baseline : High density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 72))
- Ratio to baseline : Low density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 72))
- Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol(From baseline (week 0) to end of treatment (week 72))
- Ratio to baseline : Triglycerides(From baseline (week 0) to end of treatment (week 72))
- Ratio to baseline: Free fatty acids(From baseline (week 0) to end of treatment (week 72))
- Ratio to baseline : Non-HDL cholesterol(From baseline (week 0) to end of treatment (week 72))
- Number of treatment-emergent adverse events (TEAEs)(From randomisation (week 0) to end of study (week 80))
- Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function(From randomisation (week 0) to end of treatment (week 72))
- Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function(From randomisation (week 0) to end of treatment (week 72))
- Change in glycated haemoglobin (HbA1c)(From randomisation (week 0) to end of treatment (week 72))
- Number of participants who achieve HbA1c <6.5%(At end of treatment (week 72))
- Number of participants who achieve normal HbA1c <5.7%(At end of treatment (week 72))
- Number of treatment-emergent serious adverse events (TESAEs)(From randomisation (week 0) to end of study (week 80))
研究者
研究点 (539)
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