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

NCT07874633 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: C6491029
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Obesity; Overweight

Keywords

Obesity; Overweight; Weight Management; Weight Reduction; Body Weight; Chronic Weight Management; Adults With Obesity; Adults With Overweight; Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in body weight

  Baseline, Week 48

Secondary Outcomes (39)

• Percent change from baseline in body weight in participants without T2D

  Baseline, Week 48

• Change from baseline in body weight

  Baseline, 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo by Subcutaneous Injection.

Other: Placebo

Treatment Arm 1

EXPERIMENTAL

Participants will receive Berobenatide by Subcutaneous Injection.

Drug: Berobenatide

Treatment Arm 2

EXPERIMENTAL

Participants will receive Berobenatide by Subcutaneous Injection.

Drug: Berobenatide

Treatment Arm 3

EXPERIMENTAL

Participants will receive Berobenatide by Subcutaneous Injection.

Drug: Berobenatide

Treatment Arm 4

EXPERIMENTAL

Participants will receive Berobenatide by Subcutaneous Injection.

Drug: Berobenatide

Interventions

Berobenatide DRUG

By Subcutaneous Injection

Also known as: PF-08653944

Treatment Arm 1; Treatment Arm 2; Treatment Arm 3; Treatment Arm 4

Placebo OTHER

By Subcutaneous Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

The Second People's Hospital of Hefei

Hefei, Anhui, 230011, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Links

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

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss; Body Weight; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

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: September 29, 2026
• First Posted: October 15, 2026
• Study Start: October 15, 2026
• Primary Completion (Estimated): June 6, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)