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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Other: Placebo; Drug: Berobenatide

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• China
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Anhui
    • Hefei, Anhui, China, 230011
      • The Second People's Hospital of Hefei
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital
    • Beijing, Beijing Municipality, China, 102218
      • Beijing Tsinghua Changgung Hospital
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital
    • Beijing, Beijing Municipality, China, 101200
      • Beijing Pinggu Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 404000
      • Chongqing University Three Gorges Hospital
    • Chongqing, Chongqing Municipality, China, 400013
      • Chongqing People's Hospital
  • Guangdong
    • Huizhou, Guangdong, China, 516001
      • Huizhou Central People's Hospital
  • Hebei
    • Hengshui, Hebei, China, 053000
      • Harrison International Peace Hospital
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Hospital of Harbin Medical University
  • Henan
    • Luoyang, Henan, China, 471000
      • Luoyang First People's Hospital
    • Luoyang, Henan, China, 471023
      • The First Affiliated Hospital of Henan University of Science &Technology
    • Zhengzhou, Henan, China, 450014
      • The Second Affiliated Hospital of Zhengzhou University
  • Hubei
    • Shiyan, Hubei, China, 442000
      • Shiyan Taihe Hospital
    • Wuhan, Hubei, China, 430060
      • Wuhan Third Hospital
  • Jiangsu
    • Changzhou, Jiangsu, China, 213164
      • Changzhou Second People's Hospital
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Nanjing, Jiangsu, China, 210012
      • Nanjing First Hospital
    • Nantong, Jiangsu, China, 226001
      • Affiliated Hospital of Nantong University
    • Zhenjiang, Jiangsu, China, 212001
      • Affiliated Hospital of Jiangsu University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330038
      • Jiangxi Provincial People's Hospital
    • Pingxiang, Jiangxi, China, 337000
      • Pingxiang People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130022
      • The Second Hospital of Jilin University
  • Shaanxi
    • Xi'an, Shaanxi, China, 400016
      • The First Affiliated Hospital of Xi'an Medical University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200072
      • Shanghai Tenth People's Hospital
    • Shanghai, Shanghai Municipality, China, 200240
      • The Fifth People's Hospital of Shanghai
    • Shanghai, Shanghai Municipality, China, 201299
      • Pudong New Area People's Hospital Shanghai
    • Shanghai, Shanghai Municipality, China, 200031
      • Zhongshan Hospital,Fudan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Hangzhou First People's Hospital
    • Ningbo, Zhejiang, China, 315010
      • The First Affiliated Hospital of Ningbo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Berobenatide Low Maintenance Dose; Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a low maintenance dose during the maintenance phase.	Drug: Berobenatide; Solution for injection; Other Names: PF-08653944
Experimental: Berobenatide Medium Maintenance Dose; Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a medium maintenance dose during the maintenance phase.	Drug: Berobenatide; Solution for injection; Other Names: PF-08653944
Experimental: Berobenatide High Maintenance Dose; Participants will receive Berobenatide once weekly during a dose-escalation phase followed by a high maintenance dose during the maintenance phase.	Drug: Berobenatide; Solution for injection; Other Names: PF-08653944
Placebo Comparator: Placebo Matched to Low-Dose Berobenatide; Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.	Other: Placebo; Solution for injection
Placebo Comparator: Placebo Matched to Medium-Dose Berobenatide; Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.	Other: Placebo; Solution for injection
Placebo Comparator: Placebo Matched to High-Dose Berobenatide; Participants will receive placebo administered once weekly throughout the dose-escalation phase and maintenance phase.	Other: Placebo; Solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Body Weight at Week 48	Baseline to Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change from baseline in waist circumference	Baseline, Week 48
Change from baseline in Non-High-density lipoprotein cholesterol	Baseline, Week 48
Change from baseline in Fasting triglycerides	Baseline, Week 48
Change from baseline in Systolic Blood Pressure (SBP)	Baseline, Week 48
Change from baseline in Short Form 36 health survey (SF-36) Physical Function domain score	Baseline, Week 48
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score	Baseline, Week 48
Change from baseline in Diastolic Blood Pressure (DBP)	Baseline, Week 48
Change from baseline in Fasting Total Cholesterol	Baseline, Week 48
Change from baseline in Low-density lipoprotein cholesterol	Baseline, Week 48
Change from baseline in Very low-density lipoprotein cholesterol	Baseline, Week 48
Change from baseline in High-density lipoprotein cholesterol	Baseline, Week 48
Change from Baseline in HbA1c	Baseline, Week 48
Change from baseline in Fasting Plasma Glucose	Baseline, Week 48
Change from baseline in Fasting Insulin	Baseline, Week 48
Change from baseline in hs-CRP (high-sensitivity C-reactive protein)	Baseline, Week 48
Change from baseline in Interleukin-6 (IL-6)	Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Physical Composite	Baseline, Week 48
Change from baseline in IWQoL-Lite-CT Psychosocial Composite	Baseline, Week 48
Change from baseline in SF-36 domain scales and component summary scales	Baseline, Week 48
Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score	Baseline, Week 48
Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)	Baseline, Week 48
Number of participants with Treatment Emergent Adverse Events (TEAEs)	Up to Week 58
Number of participants with Serious Adverse Events (SAE)	Up to Week 58
Number of participants with AE leading to permanent discontinuation from study intervention or study	Up to Week 58
Percentage of participants with T2D at screening achieving HbA1c <7.0%	Up to Week 48
Percentage of participants with Type 2 diabetes (T2D) at screening achieving HbA1c <5.7%	Up to Week 48
Change from Baseline in Body mass index (BMI)	Baseline, Week 48

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 14, 2028
• Study Completion (Estimated): May 23, 2028

Study Registration Dates

• First Submitted: August 25, 2026
• First Submitted That Met QC Criteria: August 25, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Body Weight; Weight Reduction; Weight Management; Chronic Weight Management; Adults With Obesity; Adults With Overweight
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss; Body Weight
• Other Study ID Numbers: C6491018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes