A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly 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-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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Other: Placebo; Drug: Berobenatide

• Study Type: Interventional
• Enrollment (Estimated): 432
• 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
  • Anhui
    • Hefei, Anhui, China, 230011
      • Not yet recruiting
      • The Second People's Hospital of Hefei
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Not yet recruiting
      • Peking University People's Hospital
  • Guangdong
    • Huizhou, Guangdong, China, 516001
      • Not yet recruiting
      • Huizhou Central People's Hospital
  • Henan
    • Zhengzhou, Henan, China, 450014
      • Not yet recruiting
      • The Second Affiliated Hospital of Zhengzhou University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330038
      • Not yet recruiting
      • Jiangxi Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive matching placebo by Subcutaneous Injection.	Other: Placebo; By Subcutaneous Injection
Experimental: Treatment Arm 1; Participants will receive Berobenatide by Subcutaneous Injection.	Drug: Berobenatide; By Subcutaneous Injection; Other Names: PF-08653944
Experimental: Treatment Arm 2; Participants will receive Berobenatide by Subcutaneous Injection.	Drug: Berobenatide; By Subcutaneous Injection; Other Names: PF-08653944
Experimental: Treatment Arm 3; Participants will receive Berobenatide by Subcutaneous Injection.	Drug: Berobenatide; By Subcutaneous Injection; Other Names: PF-08653944
Experimental: Treatment Arm 4; Participants will receive Berobenatide by Subcutaneous Injection.	Drug: Berobenatide; By Subcutaneous Injection; Other Names: PF-08653944

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline in body weight	Baseline, Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Fasting triglycerides	Baseline, Week 48
Change from baseline in Systolic Blood Pressure (SBP)	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 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 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 Visual Analogue Scale (EQ-VAS)	Baseline, Week 48
Change from Baseline in Body mass index (BMI)	Baseline, Week 48
Percent change from baseline in body weight in participants without T2D	Baseline, Week 48
Change from baseline in body weight	Baseline, Week 48
Change from baseline in Non-high-density lipoprotein-cholesterol	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 Total Cholesterol	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 High-sensitivity C-reactive protein (hs-CRP)	Baseline, Week 48
Change from baseline in Interleukin (IL)-6	Baseline, Week 48
Change from baseline in IL-1 beta	Baseline, Week 48
Change from Baseline in HbA1c in participants with T2D	Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <7.0%	Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <6.5%	Baseline, Week 48
Percentage of participants with T2D at screening achieving HbA1c <5.7%	Baseline, Week 48
Change from baseline in IWQoL-Lite-CT total score	Baseline, Week 48
Change from baseline in EuroQoL5-Dimension 5-Level (EQ-5D-5L) index score	Baseline, Week 48
Incidence proportion of Treatment-emergent adverse event (TEAE)	Up to Week 55
Incidence proportion of Serious adverse event (SAE)	Up to Week 55
Incidence proportion of Adverse event (AE) leading to permanent discontinuation from study intervention or study	Up to Week 55
Incidence proportion of Adverse events of special interest (AESIs)	Up to Week 55
Incidence proportion of Clinical laboratory abnormalities	Up to Week 55

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• <p>To obtain contact information for a study center near you, click here.</p>

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2026
• Primary Completion (Estimated): June 6, 2028
• Study Completion (Estimated): August 15, 2028

Study Registration Dates

• First Submitted: September 29, 2026
• First Submitted That Met QC Criteria: October 9, 2026
• First Posted (Actual): October 15, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Body Weight; Metabolic Diseases; 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; Metabolic Diseases
• Other Study ID Numbers: C6491029

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