A Study to Learn About Safety and Effects of Once-weekly Treatment With Berobenatide in Adults With Obesity Disease in Japan (VESPER-JW)
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-WEEKLY BEROBENATIDE IN ADULTS WITH OBESITY DISEASE IN JAPAN (VESPER-JW)
2 other identifiers
interventional
180
1 country
29
Brief 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 where a person has too much body fat, which can harm their health and increase the risk of other medical problems. Some people 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 180 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 22 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started Sep 2026
Typical duration for phase_3 obesity
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2026
CompletedFirst Posted
Study publicly available on registry
August 31, 2026
CompletedStudy Start
First participant enrolled
September 28, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 14, 2029
September 25, 2026
September 1, 2026
2.5 years
August 26, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change from baseline in body weight
Baseline, Week 72
Secondary Outcomes (37)
Change from baseline in waist circumference
Baseline, Week 72
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Baseline, Week 72
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Baseline, Week 72
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Baseline, Week 72
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Baseline, Week 72
- +32 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants will receive placebo solution for injection as subcutaneous injection.
Treatment Arm 1
EXPERIMENTALParticipants will receive berobenatide solution for injection as subcutaneous injection.
Treatment Arm 2
EXPERIMENTALParticipants will receive berobenatide solution for injection as subcutaneous injection.
Treatment Arm 3
EXPERIMENTALParticipants will receive berobenatide solution for injection as subcutaneous injection.
Interventions
Solution for injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (29)
Tenjin Sogo Clinic
Fukuoka, Fukuoka, 810-0021, Japan
Medical Corporation BOOCS BOOCS CLINIC FUKUOKA
Fukuoka, Fukuoka, 812-0025, Japan
Oishi Clinic
Kasuya-gun, Fukuoka, 811-2310, Japan
Manda Memorial Hospital
Sapporo, Hokkaido, 060-0062, Japan
Yamasaki Family Clinic
Amagasaki, Hyōgo, 660- 0861, Japan
Minami Akatsuka Clinic
Mito, Ibaraki, 311-4153, Japan
Nishiyamado Keiwa Hospital
Naka, Ibaraki, 311-0133, Japan
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
Yokohama, Kanagawa, 231-0023, Japan
Yokoi Clinic
Minoh, Osaka, 562-0003, Japan
Kanemura Clinic
Osaka-shi Ikuno-ku, Osaka, 544-0004, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, 565-0853, Japan
MI Clinic, Medical Corporation Jinsenkai
Toyonaka-shi, Osaka, 560-0004, Japan
Soka Sugiura Internal medicine Clinic
Soka-shi, Saitama, 340-0015, Japan
Doujin Memorial Foundation Meiwa Hospital
Chiyoda-ku, Tokyo, 101-0041, Japan
Aic Yaesu Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Tokyo Asbo Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Medical Corp. Seikoukai New Medical Research System Clinic
Hachioji-shi, Tokyo, 192-0046, Japan
Hachioji Clinic Shincho
Hachioji-shi, Tokyo, 192-0065, Japan
Keikokai Medical Corporation P-one Clinic
Hachiōji, Tokyo, 192-0071, Japan
Patient First Clinic Ginza-Shimbashi
Minato-ku, Tokyo, 105-0004, Japan
Shimamura Memorial Hospital
Nerima-ku, Tokyo, 177-0051, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008, Japan
Seeds Clinic Shinjuku-Sanchome, Eijinkai Medical Corporation
Shinjuku-ku, Tokyo, 160-0022, Japan
Higashi-Shinjuku Clinic, Keikokai Medical Corp.
Shinjuku-ku, Tokyo, 169-0072, Japan
Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, 171-0021, Japan
Nihonbashi Sakura Clinic
Tokyo, 103-0025, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2026
First Posted
August 31, 2026
Study Start
September 28, 2026
Primary Completion (Estimated)
March 14, 2029
Study Completion (Estimated)
March 14, 2029
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.