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NCT Number: NCT07595549

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.

About 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.

People will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Overweight and/or Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Corporation Heishinkai OCROM Clinic, Suita, Osaka, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged ≥18 years.
  • BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to <30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.

Exclusion criteria

  • Have a self-reported body weight change greater than 5% within 90 days prior to Screening.
  • Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.
  • History of acute or chronic pancreatitis.
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).

Treatment and study plan

PF-08653944

Drug

By Subcutaneous Injection

Placebo

Other

By Subcutaneous Injection

Primary outcomes

  1. Percent change from baseline in body weight

    Time frame: Baseline, Week 72

Secondary outcomes

  1. Change from baseline in body weight

    Time frame: Baseline, Week 72

  2. Change from baseline in waist circumference

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  7. Percentage of Participants with a waist-to-height ratio of <0.53

    Time frame: Baseline, Week 72

  8. Percent change from baseline in body weight in participants with type 2 diabetes

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  10. 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 72

  11. Percentage of Participants achieving ≥25% of body weight reduction from baseline

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  13. Change from Baseline in Fasting Glucose

    Time frame: Basline, Week 72

  14. Change from Baseline in Fasting insulin

    Time frame: Baseline, Week 72

  15. Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)

    Time frame: Baseline, Week 72

  16. Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)

    Time frame: Baseline, Week 72

  17. Change from Baseline in HbA1c

    Time frame: Baseline, Week 72

  18. Change from baseline in Fasting Total Cholesterol

    Time frame: Baseline, Week 72

  19. Change from baseline in Fasting Low-density lipoprotein cholesterol

    Time frame: Baseline, Week 72

  20. Change from baseline in Fasting Very low-density lipoprotein cholesterol

    Time frame: Baseline, Week 72

  21. Change from baseline in Fasting Non-High-density lipoprotein cholesterol

    Time frame: Baseline, Week 72

  22. Change from baseline in Fasting High-density lipoprotein cholesterol

    Time frame: Baseline, Week 72

  23. Change from baseline in Fasting triglycerides

    Time frame: Baseline, Week 72

  24. Change from baseline in high-sensitivity C-reactive protein

    Time frame: Baseline, Week 72

  25. Change from baseline in interleukin-6

    Time frame: Baseline, Week 72

  26. Change from baseline in interleukin-1 beta

    Time frame: Baseline, Week 72

  27. Change from baseline in IWQoL-Lite-CT total score

    Time frame: Baseline, Week 72

  28. Change from baseline in IWQoL-Lite-CT Physical composite score

    Time frame: Baseline, Week 72

  29. Change from baseline in IWQoL-Lite-CT Psychosocial composite score

    Time frame: Baseline, Week 72

  30. Change from baseline in Short Form 36 health survey (SF-36) domain scales and component summary scales

    Time frame: Baseline, Week 72

  31. Change from Baseline in Control of Eating Questionnaire (CoEQ) subscales

    Time frame: Baseline, Week 72

  32. Change from Baseline in Food Noise Questionnaire (FNQ) total score

    Time frame: Baseline, Week 72

  33. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Baseline, Week 72

  34. Number of Participants with Serious adverse events (SAEs)

    Time frame: Baseline, Week 72

  35. Number of Participants with adverse avents leading to discontinuation

    Time frame: Baseline, Week 72

  36. Number of Participants with Adverse Events of Special Interest (AESIs)

    Time frame: Baseline, Week 72

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 ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 19, 2026
Registry last updated
Jul 22, 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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