A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo in Chinese Adults With Overweight or Obesity
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-WEEKLY PF-08653944 IN CHINESE ADULTS WITH OVERWEIGHT OR OBESITY
1 other identifier
interventional
300
1 country
29
Brief Summary
Overweight and obesity are long-term health conditions that can increase the risk of serious health problems, including heart disease, type 2 diabetes, and other medical conditions. The purpose of this study is to learn whether berobenatide is safe and effective for adults in China who have overweight or obesity. Researchers will compare berobenatide with a placebo, which looks like the study treatment but does not contain active medicine. People may be able to participate if they are adults with obesity or if they have overweight together 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. The study treatment will be administered according to the study protocol, and participants will be monitored throughout the study to assess changes in body weight and overall health, as well as any side effects that may occur. During participation, participants will attend study visits and complete study-related assessments. Researchers will collect information about participants' health, body weight, and safety throughout the study. Details about the number of visits, study duration, and study procedures will be explained by the study team before participation. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Sep 2026
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2026
CompletedFirst Posted
Study publicly available on registry
August 28, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2028
Study Completion
Last participant's last visit for all outcomes
May 23, 2028
August 28, 2026
August 1, 2026
1.5 years
August 25, 2026
August 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Body Weight at Week 48
Baseline to Week 48
Secondary Outcomes (32)
Change From Baseline in Body Weight at Week 48
Baseline to Week 48
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Baseline, Week 48
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Baseline, Week 48
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Baseline, Week 48
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Baseline, Week 48
- +27 more secondary outcomes
Study Arms (6)
Berobenatide Low Maintenance Dose
EXPERIMENTALParticipants will receive Berobenatide once weekly during a dose-escalation phase followed by a low maintenance dose during the maintenance phase.
Berobenatide Medium Maintenance Dose
EXPERIMENTALParticipants will receive Berobenatide once weekly during a dose-escalation phase followed by a medium maintenance dose during the maintenance phase.
Berobenatide High Maintenance Dose
EXPERIMENTALParticipants will receive Berobenatide once weekly during a dose-escalation phase followed by a high maintenance dose during the maintenance phase.
Placebo Matched to Low-Dose Berobenatide
PLACEBO COMPARATORParticipants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.
Placebo Matched to Medium-Dose Berobenatide
PLACEBO COMPARATORParticipants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.
Placebo Matched to High-Dose Berobenatide
PLACEBO COMPARATORParticipants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.
Interventions
Solution for injection
Solution for injection
Eligibility Criteria
You may qualify if:
- Adults ≥18 years of age.
- BMI ≥28 kg/m²; or BMI ≥24 kg/m² and \<28 kg/m² with at least one weight-related comorbidity.
- Participants with T2D must have HbA1c 6.5% to 10.0%.
- At least one prior unsuccessful dietary weight-loss attempt.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (29)
The Second People's Hospital of Hefei
Hefei, Anhui, 230011, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Beijing Pinggu Hospital
Beijing, Beijing Municipality, 101200, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Chongqing People's Hospital
Chongqing, Chongqing Municipality, 400013, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516001, China
Harrison International Peace Hospital
Hengshui, Hebei, 053000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Luoyang First People's Hospital
Luoyang, Henan, 471000, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471023, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014, China
Shiyan Taihe Hospital
Shiyan, Hubei, 442000, China
Wuhan Third Hospital
Wuhan, Hubei, 430060, China
Changzhou Second People's Hospital
Changzhou, Jiangsu, 213164, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330038, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337000, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
The Fifth People's Hospital of Shanghai
Shanghai, Shanghai Municipality, 200240, China
Pudong New Area People's Hospital Shanghai
Shanghai, Shanghai Municipality, 201299, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006, China
The first affiliated hospital of Ningbo university
Ningbo, Zhejiang, 315010, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2026
First Posted
August 28, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
March 14, 2028
Study Completion (Estimated)
May 23, 2028
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
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.