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

Sponsor
Pfizer
Study ID
NCT07794774
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Berobenatide — DRUG
    Subcutaneous Injection
  • Placebo — OTHER
    Subcutaneous Injection

Study Details

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.

Key Dates

First listed
Aug 31, 2026
Start date
Sep 28, 2026
Status verified
Aug 2026
Primary completion
Feb 21, 2029
Completion
Feb 21, 2029

Study Design

Enrollment
197 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo
    Participants will receive placebo solution for injection as subcutaneous injection.
  • Experimental: Treatment Arm 1
    Participants will receive berobenatide solution for injection as subcutaneous injection.
  • Experimental: Treatment Arm 2
    Participants will receive berobenatide solution for injection as subcutaneous injection.
  • Experimental: Treatment Arm 3
    Participants will receive berobenatide solution for injection as subcutaneous injection.
  • Experimental: Treatment Arm 4
    Participants will receive berobenatide solution for injection as subcutaneous injection.

Primary Outcome Measure

Percent change from baseline in body weight [ Time Frame: Baseline, Week 72 ]

Central Contacts

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