A Clinical Study Testing Enicepatide in Participants Living With Overweight or Obesity and Cardiovascular Disease (Enith-MACE)
2026年11月2日 更新者：Hoffmann-La Roche
A Phase III, Randomized, Double-Blind, Placebo-controlled, Trial to Evaluate the Efficacy and Safety of Enicepatide in Participants With Overweight or Obesity and Cardiovascular Disease
The purpose of this study is to evaluate the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), as a therapy to reduce the risk of major adverse cardiovascular events (MACE) in adults living with overweight or obesity and established cardiovascular disease (CVD), with or without type 2 diabetes mellitus (T2DM).
研究概览
研究类型
介入性
注册 (估计的)
8200
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry
研究联系人备份
- 姓名：Reference Study ID Number: WC46385 https://forpatients.roche.com/ No attachments to email below
- 电话号码：888-662-6728 (U.S. Only)
- 邮箱：global-roche-genentech-trials@gene.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Body Mass Index (BMI) ≥25.0 kilograms per meter square (kg/m2)
- Have established and stable cardiovascular disease (CVD)
- Participants should be treated with stable (per investigator judgment) background therapy for CVD, such as hyperlipidemia and T2DM (if relevant), as per local and international guidelines, excluding use of GLP-1 RA-based therapies
- For participants with T2DM: HbA1c ≤10% based on central laboratory assessment at Screening
Exclusion Criteria:
- History of type 1 diabetes mellitus, or any lifetime history of ketoacidosis or hyperosmolar state/coma within 12 months prior to Screening
- Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study per investigator judgment
- Any preplanned major medical procedure or surgery at the time of Screening including planning to have a surgical, endoscopic, or device treatment for obesity
- Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
- Chronic dialysis (e.g., chronic hemodialysis, chronic peritoneal dialysis)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Arm 1: Placebo
Participants will receive volume-matched placebo. |
Participants will receive volume-matched placebo as per the schedule described in the protocol. |
|
实验性的：Arm 2: Enicepatide
Participants will receive enicepatide. |
Participants will receive enicepatide as per the schedule described in the protocol.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to First Occurrence of Any Component of 5-point (5P) MACE
大体时间：From randomization up to 4.2 years
|
The components of this composite 5P MACE endpoint consist of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for heart failure (HHF) or urgent heart failure (HF) visit, or urgent coronary revascularization. |
From randomization up to 4.2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to First Occurrence of Any Component of 3-point (3P) MACE
大体时间：From randomization up to 4.2 years
|
The components of this composite 3P MACE endpoint consist of CV death, non-fatal MI or non-fatal stroke. |
From randomization up to 4.2 years
|
|
Time to New-Onset T2DM
大体时间：From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
|
Total Occurrence of All-Cause Hospitalization
大体时间：From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Time to Death From Any Cause
大体时间：From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Time to CV Death
大体时间：From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Incidence and Severity of Adverse Events
大体时间：From baseline up to 4.2 years
|
From baseline up to 4.2 years
|
|
|
Time to First Occurrence of Any Component of 4-point (4P) MACE
大体时间：From randomization up to 4.2 years
|
The components of this composite 4P MACE endpoint consist of CV death, non-fatal MI, non-fatal stroke, or HHF or urgent HF visit. |
From randomization up to 4.2 years
|
|
Time to First Occurrence of HHF, Urgent HF Visit, or CV Death
大体时间：From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
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Time to First Occurrence of HHF, Urgent HF Visit, or All-Cause Mortality
大体时间：From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
|
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the Short Form 36 Health Survey Version 2.0 (SF-36 V2) Acute Form Physical Functioning Domain Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Physical Domain Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Bodily Pain Domain Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form General Health Domain Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Vitality Domain Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
|
|
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Social Functioning Domain Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Role-Emotional Domain Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Health Domain Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
|
|
Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Physical Component Summary Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in HRQoL as Assessed by the SF-36 V2 Acute Form Mental Component Summary Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
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Change From Baseline in Health Status as Assessed by the EuroQol-5 Dimensions 5-Level (EQ-5D-5L) Score
大体时间：From baseline through Week 48
|
From baseline through Week 48
|
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Time To First Occurrence of Sustained ≥40% Estimated Glomerular Filtration Rate (eGFR) Decline From Baseline, End Stage Kidney Disease (ESKD), or Renal Death
大体时间：From randomization up to 4.2 years
|
From randomization up to 4.2 years
|
|
|
Change From Baseline in Body Weight
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Waist Circumference
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Waist-to-Height Ratio
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Systolic Blood Pressure
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Diastolic Blood Pressure
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Heart Rate
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
|
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Change From Baseline in Double Product
大体时间：From baseline through the end of study (up to 4.2 years)
|
Double product is defined as heart rate multiplied by systolic blood pressure. |
From baseline through the end of study (up to 4.2 years)
|
|
Change From Baseline in Pulse Pressure
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Mean Arterial Pressure
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
|
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Change From Baseline in Total Cholesterol
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
|
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Change From Baseline in Non-High-Density Lipoprotein (HDL)
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Low-Density Lipoprotein (LDL)
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
|
|
Change From Baseline in HDL
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
|
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Change From Baseline in Triglycerides (TG)
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
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Change From Baseline in Very-low-Density Lipoprotein (vLDL)
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
|
|
Change From Baseline in Hemoglobin A1c (HbA1c)
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
|
|
Change From Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
|
|
Change From Baseline in N-Terminal pro-B-Type Natriuretic Peptide (NT-proBNP)
大体时间：From baseline through the end of study (up to 4.2 years)
|
From baseline through the end of study (up to 4.2 years)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年1月6日
初级完成 (估计的)
2031年3月20日
研究完成 (估计的)
2031年4月17日
研究注册日期
首次提交
2026年11月2日
首先提交符合 QC 标准的
2026年11月2日
首次发布 (实际的)
2026年11月5日
研究记录更新
最后更新发布 (实际的)
2026年11月5日
上次提交的符合 QC 标准的更新
2026年11月2日
最后验证
2026年10月1日
更多信息
与本研究相关的术语
其他研究编号
- WC46385
- 2026-526958-14-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.