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

StatusNot Yet Recruiting
PhasePhase 3
SponsorPfizer
Started

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Record History

  1. Minor Trial sites expanded: 11 → 28 locations
  2. Minor Trial sites expanded: 6 → 11 locations
  3. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
438 trials monitored
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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.
Trial Details
NCT Number NCT07794774
Lead Sponsor Pfizer
Conditions
(from sponsor)
Obesity
Related terms Obesity, Overweight
Enrollment 197 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov