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NCT Number: NCT07794774

A Study to Learn About Safety and Effects of Once-monthly Treatment With Berobenatide in Adults With Obesity Disease in Japan (VESPER-JM)

The purpose of this clinical study is to learn about safety and effects of berobenatide (PF-08653944) in adults with obesity disease, a condition in which a person has too much body fat, which can harm their health and increase the risk of other medical problems. Some participants in this study may also have type 2 diabetes, a condition in which the body does not use insulin properly, causing blood sugar levels to become too high.

This study is seeking participants in Japan who:

* Have obesity disease. * May have type 2 diabetes. * Meet the study-specific age, weight, and health requirements.

About 197 adults will take part in this study. Participants will be randomly assigned to receive either berobenatide or a placebo. A placebo looks like the study medicine but does not contain any active medicine.

Berobenatide or placebo will be given as an injection under the skin of the abdomen (belly area). The study will compare the experiences of people receiving berobenatide with those receiving placebo to determine whether berobenatide can help people lose weight. The study will also assess the safety of berobenatide and its effects on body weight and other health measures.

People will take part in this study for about 21 months. During this time, they will have about 16 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 Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight 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

Manda Memorial Hospital, Sapporo, Hokkaido, 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: ≥27.0 kg/m2 to <35.0 kg/m2 with ≥2 obesity-related health disorders or BMI of ≥35.0 kg/m2 with ≥1 obesity-related health disorder. The participant must have at least one of either hypertension, dyslipidemia or glucose intolerance (T2D and impaired glucose tolerance etc.) as an obesity-related health disorder.

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

Berobenatide

Drug

Subcutaneous Injection

Other names: MET097, PF-08653944

Placebo

Other

Subcutaneous Injection

Primary outcomes

  1. Percent change from baseline in body weight

    Time frame: Baseline, Week 72

Secondary outcomes

  1. Change from baseline in waist circumference

    Time frame: Baseline, Week 72

  2. Percentage of participants achieving ≥10% of body weight reduction from baseline

    Time frame: Baseline, Week 72

  3. Percentage of participants achieving ≥15% of body weight reduction from baseline

    Time frame: Baseline, Week 72

  4. Percentage of participants achieving ≥20% of body weight reduction from baseline

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  6. Change from baseline in body weight

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  9. 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

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

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

    Time frame: Baseline, Week 72

  13. Change from baseline in fasting glucose

    Time frame: Baseline, 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. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Week 72

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

    Time frame: Week 72

  29. Number of participants with adverse events leading to discontinuation

    Time frame: Week 72

  30. Number of participants with Adverse Events of Special Interest (AESIs)

    Time frame: Week 72

  31. Number of participants with absolute and change from baseline in laboratory measurements

    Time frame: Week 72

  32. Change from baseline in visceral fat area

    Time frame: Baseline, Week 72

  33. Percentage of participants achieving visceral fat area <100 cm2

    Time frame: Week 72

  34. Percentage of participants achieving the conversion to normoglycemia

    Time frame: Week 72

  35. Change from baseline in Oral Glucose Tolerance Test (OGTT) 2h

    Time frame: Baseline, Week 72

  36. Percentage of participants achieving conversion from HbA1c ≥7% to HbA1c <7%

    Time frame: Week 72

  37. Percentage of participants achieving conversion from HbA1c ≥5.7% to HbA1c <5.7%

    Time frame: 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 BEROBENATIDE IN ADULTS WITH OBESITY DISEASE IN JAPAN (VESPER-JM)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 31, 2026
Registry last updated
Aug 31, 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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