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NOT YET RECRUITING
NCT07794774
PHASE3

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

View on ClinicalTrials.gov

Summary

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.

Official 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

197

Start Date

2026-09-28

Completion Date

2029-02-21

Last Updated

2026-08-31

Healthy Volunteers

No

Conditions

Interventions

DRUG

Berobenatide

Subcutaneous Injection

OTHER

Placebo

Subcutaneous Injection

Locations (6)

Manda Memorial Hospital

Sapporo, Hokkaido, Japan

Medical Corporation Heishinkai OCROM Clinic

Suita, Osaka, Japan

Tokyo Center Clinic

Chuo-ku, Tokyo, Japan

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, Japan

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Medical Corporation Heishinkai ToCROM Clinic

Shinjuku-ku, Tokyo, Japan