Clinical Trials in Japan / NCT07794774
Starting soon Phase 3

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

NCT07794774 · tracked via the Priya Life Science Japan tracker
Sponsor
Phase
Phase 3
Started
2026-09-28
Last updated
2026-09-25

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Berobenatide →Placebo

Berobenatide: Subcutaneous Injection

Placebo: Subcutaneous Injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Tenjin Sogo Clinic Fukuoka Fukuoka
Medical Corporation BOOCS BOOCS CLINIC FUKUOKA Fukuoka Fukuoka
Oishi Clinic Kasuya-gun Fukuoka
Manda Memorial Hospital Sapporo Hokkaido
Yamasaki Family Clinic Amagasaki Hyōgo
Minami Akatsuka Clinic Mito Ibaraki
Nishiyamado Keiwa Hospital Naka Ibaraki
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic Yokohama Kanagawa
Yokoi Clinic Minoh Osaka
Kanemura Clinic Osaka-shi Ikuno-ku Osaka
Medical Corporation Heishinkai OCROM Clinic Suita Osaka
MI Clinic, Medical Corporation Jinsenkai Toyonaka-shi Osaka
Soka Sugiura Internal medicine Clinic Soka-shi Saitama
Aic Yaesu Clinic Chuo-ku Tokyo
Tokyo Center Clinic Chuo-ku Tokyo
Tokyo-Eki Center-building Clinic Chuo-ku Tokyo
Fukuwa Clinic Chuo-ku Tokyo
Tokyo Asbo Clinic Chuo-ku Tokyo
Medical Corp. Seikoukai New Medical Research System Clinic Hachioji-shi Tokyo
Hachioji Clinic Shincho Hachioji-shi Tokyo
Keikokai Medical Corporation P-one Clinic Hachiōji Tokyo
Patient First Clinic Ginza-Shimbashi Minato-ku Tokyo
Shimamura Memorial Hospital Nerima-ku Tokyo
Medical Corporation Heishinkai ToCROM Clinic Shinjuku-ku Tokyo
Seeds Clinic Shinjuku-Sanchome, Eijinkai Medical Corporation Shinjuku-ku Tokyo
Higashi-Shinjuku Clinic, Keikokai Medical Corp. Shinjuku-ku Tokyo
Ikebukuro Metropolitan Clinic Toshima-ku Tokyo
Nihonbashi Sakura Clinic Tokyo Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07794774 on ClinicalTrials.gov ↗ ← All trials in Japan