A Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight (ZYNERGY)
2026年9月7日 更新者：Hoffmann-La Roche
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Petrelintide Co-Administered With RO7795068 in Adults With Obesity or Overweight
The main purpose of this study is to evaluate the safety and efficacy of the co-administration of petrelintide and enicepatide compared with placebo, petrelintide monotherapy, and enicepatide monotherapy in participants with obesity or overweight with at least one weight-related comorbidity.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
486
阶段
- 阶段2
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: CC46372 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
- 成人
- 年长者
接受健康志愿者
不
描述
Key Inclusion Criteria:
- Male or female participants with Body Mass Index (BMI) ≥ 30 kg/m² OR BMI ≥ 27 kg/m² to < 30 kg/m² with at least one weight-related comorbidity
- History of at least one self-reported unsuccessful dietary effort to lose body weight
Key Exclusion Criteria:
- HbA1c ≥ 48 mmol/mol (6.5%) at screening
- History of Type 1 or Type 2 Diabetes
- Self-reported change in body weight > 5 kg within 90 days prior to screening
- Previous or planned obesity treatment with surgery (excluding liposuction, cryolipolysis, or abdominoplasty if performed > 1 year prior to or during screening)
- Previous or planned endoscopic and/or device-based obesity treatment or removal or device within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal endoluminal liner)
- Treatment with any GLP-1 receptor agonist, GLP-1/GIP receptor agonist (or any other GLP-1 based treatment) within 180 days prior to or during screening
- Current or previous treatment with petrelintide or any other amylin analog
- Obesity induced by Cushing syndrome or a diagnosis of monogenetic or syndromic forms of obesity
- History of severe psychiatric disorders
- History of any hematologic conditions that may interfere with HbA1c measurement
- Known history or presence of pancreatitis
- Known clinically significant gastric emptying abnormality or chronic treatment that affects GI motility
- New York Heart Association Functional Classification IV heart failure
- Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required
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 |
|---|---|
|
实验性的：Arm 1: Petrelintide + Enicepatide Dosing Regimen 1
|
Petrelintide will be administered subcutaneously to participants once weekly
其他名称：
Enicepatide will be administered subcutaneously to participants once weekly
其他名称：
|
|
实验性的：Arm 2: Petrelintide + Enicepatide Dosing Regimen 2
|
Petrelintide will be administered subcutaneously to participants once weekly
其他名称：
Enicepatide will be administered subcutaneously to participants once weekly
其他名称：
|
|
实验性的：Arm 3: Petrelintide + Enicepatide Dosing Regimen 3
|
Petrelintide will be administered subcutaneously to participants once weekly
其他名称：
Enicepatide will be administered subcutaneously to participants once weekly
其他名称：
|
|
实验性的：Arm 4: Petrelintide-matching Placebo + Enicepatide
|
Enicepatide will be administered subcutaneously to participants once weekly
其他名称：
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
|
|
实验性的：Arm 5: Petrelintide + Enicepatide-matching Placebo
|
Petrelintide will be administered subcutaneously to participants once weekly
其他名称：
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly
|
|
安慰剂比较：Arm 6: Petrelintide-matching Placebo + Enicepatide-matching Placebo
|
Matching placebo to Petrelintide will be administered subcutaneously to participants once weekly
Matching placebo to Enicepatide will be administered subcutaneously to participants once weekly
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Percentage Change in Body Weight between Arms 1 and 6
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Percentage Change in Body Weight between Arms 2, 3 and Arm 6
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Percentage Change in Body Weight between Arms 1, 2, 3 and Arms 4, 5
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Percentage of Participants Achieving Body Weight Loss
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Body Weight (kilograms [kg])
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Body Mass Index (kilograms per square meter [kg/m²])
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Waist Circumference (centimeter [cm])
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Hemoglobin A1c (HbA1c) (percentage-points)
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Fasting Insulin
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Fasting Glucose
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Systolic Blood Pressure
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Diastolic Blood Pressure
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in High-Density Lipoprotein (HDL) Cholesterol
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Low-Density Lipoprotein (LDL) Cholesterol
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Very-Low-Density Lipoprotein (VLDL) Cholesterol
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Non-HDL Cholesterol
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Total Cholesterol
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Free Fatty Acids
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in Triglycerides
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Change in High-Sensitivity C-reactive Protein (hsCRP)
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
|
Number of Participants with Adverse Events (AEs)
大体时间：From Baseline to Week 40
|
From Baseline to Week 40
|
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)
2026年9月30日
初级完成 (估计的)
2027年11月12日
研究完成 (估计的)
2028年1月31日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月15日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月7日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
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.