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NCT Number: NCT07792954

A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Weekly Compared to Placebo 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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second People's Hospital of Hefei, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Berobenatide

Drug

Solution for injection

Other names: PF-08653944

Placebo

Other

Solution for injection

Primary outcomes

  1. Percent Change From Baseline in Body Weight at Week 48

    Time frame: Baseline to Week 48

Secondary outcomes

  1. Change From Baseline in Body Weight at Week 48

    Time frame: Baseline to Week 48

  2. Percentage of Participants achieving ≥5% of body weight reduction from baseline

    Time frame: Baseline, Week 48

  3. Percentage of Participants achieving ≥10% of body weight reduction from baseline

    Time frame: Baseline, Week 48

  4. Percentage of Participants achieving ≥15% of body weight reduction from baseline

    Time frame: Baseline, Week 48

  5. Percentage of Participants achieving ≥20% of body weight reduction from baseline

    Time frame: Baseline, Week 48

  6. Change from baseline in waist circumference

    Time frame: Baseline, Week 48

  7. Change from baseline in Non-High-density lipoprotein cholesterol

    Time frame: Baseline, Week 48

  8. Change from baseline in Fasting triglycerides

    Time frame: Baseline, Week 48

  9. Change from baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 48

  10. Change from baseline in Short Form 36 health survey (SF-36) Physical Function domain score

    Time frame: Baseline, Week 48

  11. Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score

    Time frame: Baseline, Week 48

  12. Change from baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 48

  13. Change from baseline in Fasting Total Cholesterol

    Time frame: Baseline, Week 48

  14. Change from baseline in Low-density lipoprotein cholesterol

    Time frame: Baseline, Week 48

  15. Change from baseline in Very low-density lipoprotein cholesterol

    Time frame: Baseline, Week 48

  16. Change from baseline in High-density lipoprotein cholesterol

    Time frame: Baseline, Week 48

  17. Change from Baseline in HbA1c

    Time frame: Baseline, Week 48

  18. Change from baseline in Fasting Plasma Glucose

    Time frame: Baseline, Week 48

  19. Change from baseline in Fasting Insulin

    Time frame: Baseline, Week 48

  20. Change from baseline in hs-CRP (high-sensitivity C-reactive protein)

    Time frame: Baseline, Week 48

  21. Change from baseline in Interleukin-6 (IL-6)

    Time frame: Baseline, Week 48

  22. Change from baseline in IWQoL-Lite-CT Physical Composite

    Time frame: Baseline, Week 48

  23. Change from baseline in IWQoL-Lite-CT Psychosocial Composite

    Time frame: Baseline, Week 48

  24. Change from baseline in SF-36 domain scales and component summary scales

    Time frame: Baseline, Week 48

  25. Change from baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) index score

    Time frame: Baseline, Week 48

  26. Change from baseline in EuroQol Visual Analogue Scale (EQ-VAS)

    Time frame: Baseline, Week 48

  27. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Week 58

  28. Number of participants with Serious Adverse Events (SAE)

    Time frame: Up to Week 58

  29. Number of participants with AE leading to permanent discontinuation from study intervention or study

    Time frame: Up to Week 58

  30. Percentage of participants with T2D at screening achieving HbA1c <7.0%

    Time frame: Up to Week 48

  31. Percentage of participants with Type 2 diabetes (T2D) at screening achieving HbA1c <5.7%

    Time frame: Up to Week 48

  32. Change from Baseline in Body mass index (BMI)

    Time frame: Baseline, Week 48

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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