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A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity

2026年11月4日 更新者：Pfizer

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF 08653944 IN CHINESE ADULTS WITH OVERWEIGHT OR OBESITY

Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems. These problems include heart disease, type 2 diabetes (a condition that causes high blood sugar), and other medical conditions. The purpose of this study is to learn whether berobenatide (PF-08653944) is safe and effective for adults in China who are overweight or obese. Researchers will compare berobenatide with a placebo. A placebo looks like study treatment but does not contain active medicine.

About 432 adults will take part in this study. This study is seeking adults who

  • are obese
  • are overweight with certain weight-related health conditions. Some participants may also have type 2 diabetes. Specific eligibility requirements will be reviewed by the study doctor before enrollment.

Participants will be randomly assigned to receive either berobenatide or placebo. Study treatment will be administered as a shot under the skin. All participants will also receive lifestyle counseling throughout the study.

Researchers will monitor participants throughout the study. They will assess participants' body weight, overall health, and any reactions that may occur. During the study, participants will attend study visits and complete study-related assessments.

Participants may take part in the study for up to approximately 59 weeks. This period includes screening, treatment, and follow-up visits. The information learned from this study may help researchers better understand whether berobenatide could be a treatment option for adults living with overweight or obesity.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

432

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

学习地点

  • 中国
    • Anhui
      • Hefei、Anhui、中国、230011
        • 尚未招聘
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100044
        • 尚未招聘
        • Peking University People's Hospital
    • Guangdong
      • Huizhou、Guangdong、中国、516001
        • 尚未招聘
        • Huizhou Central People's Hospital
    • Henan
      • Zhengzhou、Henan、中国、450014
        • 尚未招聘
        • The Second Affiliated Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing、Jiangsu、中国、210011
        • 招聘中
        • The Second Affiliated Hospital of Nanjing Medical University
    • Jiangxi
      • Nanchang、Jiangxi、中国、330038
        • 尚未招聘
        • Jiangxi Provincial People's Hospital

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:

  • Adults ≥18 years of age.
  • BMI ≥28 kg/m²; or BMI ≥24 kg/m² and <28 kg/m² with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.
  • At least one prior unsuccessful dietary weight-loss attempt.

Exclusion Criteria:

  • Significant recent weight change (>5% within 3 months).
  • Type 1 diabetes mellitus.
  • History of pancreatitis.
  • Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple endocrine neoplasia type 2 (MEN2).
  • Recent bariatric surgery or obesity procedures.
  • Pregnancy or breastfeeding.

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：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo

Participants will receive matching placebo by Subcutaneous Injection.
其他：Placebo

By Subcutaneous Injection
实验性的：Treatment Arm 1

Participants will receive Berobenatide by Subcutaneous Injection.
药品：Berobenatide

By Subcutaneous Injection

其他名称：
  • PF-08653944
实验性的：Treatment Arm 2

Participants will receive Berobenatide by Subcutaneous Injection.
药品：Berobenatide

By Subcutaneous Injection

其他名称：
  • PF-08653944
实验性的：Treatment Arm 3

Participants will receive Berobenatide by Subcutaneous Injection.
药品：Berobenatide

By Subcutaneous Injection

其他名称：
  • PF-08653944
实验性的：Treatment Arm 4

Participants will receive Berobenatide by Subcutaneous Injection.
药品：Berobenatide

By Subcutaneous Injection

其他名称：
  • PF-08653944

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Percent change from baseline in body weight
大体时间：Baseline, Week 48
Baseline, Week 48

次要结果测量

结果测量
大体时间
Percentage of Participants achieving ≥5% of body weight reduction from baseline
大体时间：Baseline, Week 48
Baseline, Week 48
Percentage of Participants achieving ≥10% of body weight reduction from baseline
大体时间：Baseline, Week 48
Baseline, Week 48
Percentage of Participants achieving ≥15% of body weight reduction from baseline
大体时间：Baseline, Week 48
Baseline, Week 48
Percentage of Participants achieving ≥20% of body weight reduction from baseline
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in waist circumference
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Fasting triglycerides
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Systolic Blood Pressure (SBP)
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Diastolic Blood Pressure (DBP)
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Low-density lipoprotein cholesterol
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Very low-density lipoprotein cholesterol
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in High-density lipoprotein cholesterol
大体时间：Baseline, Week 48
Baseline, Week 48
Change from Baseline in HbA1c
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Physical Composite
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Psychosocial Composite
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in SF-36 domain scales and component summary scales
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)
大体时间：Baseline, Week 48
Baseline, Week 48
Change from Baseline in Body mass index (BMI)
大体时间：Baseline, Week 48
Baseline, Week 48
Percent change from baseline in body weight in participants without T2D
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in body weight
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Non-high-density lipoprotein-cholesterol
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Short-Form 36 health survey (SF-36) Physical Function domain score
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Total Cholesterol
大体时间：Baseline, Week 48
Baseline, Week 48
Change from Baseline in Fasting plasma glucose
大体时间：Baseline, Week 48
Baseline, Week 48
Change from Baseline in Fasting insulin
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in High-sensitivity C-reactive protein (hs-CRP)
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in Interleukin (IL)-6
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in IL-1 beta
大体时间：Baseline, Week 48
Baseline, Week 48
Change from Baseline in HbA1c in participants with T2D
大体时间：Baseline, Week 48
Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <7.0%
大体时间：Baseline, Week 48
Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <6.5%
大体时间：Baseline, Week 48
Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <5.7%
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in IWQoL-Lite-CT total score
大体时间：Baseline, Week 48
Baseline, Week 48
Change from baseline in EuroQoL5-Dimension 5-Level (EQ-5D-5L) index score
大体时间：Baseline, Week 48
Baseline, Week 48
Incidence proportion of Treatment-emergent adverse event (TEAE)
大体时间：Up to Week 55
Up to Week 55
Incidence proportion of Serious adverse event (SAE)
大体时间：Up to Week 55
Up to Week 55
Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study
大体时间：Up to Week 55
Up to Week 55
Incidence proportion of Adverse events of special interest (AESIs)
大体时间：Up to Week 55
Up to Week 55
Incidence proportion of Clinical laboratory abnormalities
大体时间：Up to Week 55
Up to Week 55

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。

赞助

Pfizer

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

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。

有用的网址

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 (实际的)

2026年10月28日

初级完成 (估计的)

2028年6月6日

研究完成 (估计的)

2028年8月15日

研究注册日期

首次提交

2026年9月29日

首先提交符合 QC 标准的

2026年10月9日

首次发布 (实际的)

2026年10月15日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • C6491029

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

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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

在美国制造并从美国出口的产品

是的

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.

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