ObesityPhase 3NCT07794761
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 study testing Berobenatide in people with Obesity, run by Pfizer at 34 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Berobenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 34 sitesJapan
- Study dates
- 2 Oct 2026to 14 Mar 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
Japan34 sites, 34 recruiting
- Not yet recruiting
Yamasaki Family Clinic
Amagasaki, Hyōgo, 660- 0861
- Not yet recruiting
Tokuyama Clinic
Chiba, Chiba, 261-0004
- Recruiting
Doujin Memorial Foundation Meiwa Hospital
Chiyoda-ku, Tokyo, 101-0041
- Recruiting
AIC Yaesu Clinic
Chuo-ku, Tokyo, 103-0027
- Not yet recruiting
Aic Yaesu Clinic
Chuo-ku, Tokyo, 103-0027
- Recruiting
Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0027
- Not yet recruiting
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027
- Not yet recruiting
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
- Recruiting
Tokyo Asbo Clinic
Chuo-ku, Tokyo, 104-0031
- Not yet recruiting
Tenjin Sogo Clinic
Fukuoka, Fukuoka, 810-0021
- Not yet recruiting
Medical Corporation BOOCS BOOCS CLINIC FUKUOKA
Fukuoka, Fukuoka, 812-0025
- Not yet recruiting
Keikokai Medical Corporation P-one Clinic
Hachiōji, Tokyo, 192-0071
- Recruiting
Medical Corp. Seikoukai New Medical Research System Clinic
Hachioji-shi, Tokyo, 192-0046
- Recruiting
Hachioji Clinic Shincho
Hachioji-shi, Tokyo, 192-0065
- Recruiting
Oishi Clinic
Kasuya-gun, Fukuoka, 811-2310
- Not yet recruiting
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Matsuyama, Ehime, 790-0034
- Not yet recruiting
Matsuyama Shimin Hospital
Matsuyama, Ehime, 790-0067
- Not yet recruiting
Patient First Clinic Ginza-Shimbashi
Minato-ku, Tokyo, 105-0004
- Not yet recruiting
Yokoi Clinic
Minoh, Osaka, 562-0003
- Not yet recruiting
Minami Akatsuka Clinic
Mito, Ibaraki, 311-4153
- Not yet recruiting
Nishiyamado Keiwa Hospital
Naka, Ibaraki, 311-0133
- Recruiting
Shimamura Memorial Hospital
Nerima-ku, Tokyo, 177-0051
- Not yet recruiting
Kanemura Clinic
Osaka-shi Ikuno-ku, Osaka, 544-0004
- Recruiting
Manda Memorial Hospital
Sapporo, Hokkaido, 060-0062
- Recruiting
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008
- Recruiting
Seeds Clinic Shinjuku-Sanchome, Eijinkai Medical Corporation
Shinjuku-ku, Tokyo, 160-0022
- Recruiting
Higashi-Shinjuku Clinic, Keikokai Medical Corp.
Shinjuku-ku, Tokyo, 169-0072
- Not yet recruiting
Soka Sugiura Internal medicine Clinic
Soka-shi, Saitama, 340-0015
- Recruiting
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, 565-0853
- Not yet recruiting
Olive Takamatsu Medical Clinic
Takamatsu, Kagawa-ken, 760-0076
- Recruiting
Nihonbashi Sakura Clinic
Tokyo, 103-0025
- Recruiting
Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, 171-0021
- Recruiting
MI Clinic, Medical Corporation Jinsenkai
Toyonaka-shi, Osaka, 560-0004
- Not yet recruiting
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
Yokohama, Kanagawa, 231-0023
About this study
Official title: 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)
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:
Read more
- 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.
- Conditions
- Obesity
- Being tested
- Berobenatide, Placebo
- Keywords
- obesity, overweight, obesity disease
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerobenatideDrug
Also called MET097, PF-08653944
Solution for injection
PlaceboOther
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 2 | Experimental | Participants will receive berobenatide solution for injection as subcutaneous injection. Receives: Drug: Berobenatide |
| Placebo | Placebo comparator | Participants will receive placebo solution for injection as subcutaneous injection. Receives: Other: Placebo |
| Treatment Arm 3 | Experimental | Participants will receive berobenatide solution for injection as subcutaneous injection. Receives: Drug: Berobenatide |
| Treatment Arm 1 | Experimental | Participants will receive berobenatide solution for injection as subcutaneous injection. Receives: Drug: Berobenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in body weight
Measured: Baseline, Week 72
Secondary outcomes (37)
Change from baseline in waist circumference
Measured: Baseline, Week 72
Percentage of Participants achieving ≥10% of body weight reduction from baseline
Measured: Baseline, Week 72
Percentage of Participants achieving ≥15% of body weight reduction from baseline
Measured: Baseline, Week 72
Percentage of Participants achieving ≥20% of body weight reduction from baseline
Measured: Baseline, Week 72
Percentage of Participants achieving ≥5% of body weight reduction from baseline
Measured: Baseline, Week 72
Change from baseline in body weight
Measured: Baseline, Week 72
Change from baseline in Systolic Blood Pressure (SBP)
Measured: Baseline, Week 72
Change from baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline, Week 72
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
Measured: Baseline, Week 72
Change from baseline in IWQoL-Lite-CT total score
Measured: Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Physical composite score
Measured: Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Psychosocial composite score
Measured: Baseline, Week 72
Change from Baseline in Fasting Plasma Glucose
Measured: Baseline, Week 72
Change from Baseline in Fasting Insulin
Measured: Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)
Measured: Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)
Measured: Baseline, Week 72
Change from Baseline in HbA1c
Measured: Baseline, Week 72
Change from baseline in Fasting Total Cholesterol
Measured: Baseline, Week 72
Change from baseline in Fasting Low-density lipoprotein cholesterol
Measured: Baseline, Week 72
Change from baseline in Fasting Very low-density lipoprotein cholesterol
Measured: Baseline, Week 72
Change from baseline in Fasting Non-High-density lipoprotein cholesterol
Measured: Baseline, Week 72
Change from baseline in Fasting High-density lipoprotein cholesterol
Measured: Baseline, Week 72
Change from baseline in Fasting triglycerides
Measured: Baseline, Week 72
Change from baseline in high-sensitivity C-reactive protein
Measured: Baseline, Week 72
Change from baseline in interleukin-6
Measured: Baseline, Week 72
Change from baseline in interleukin-1 beta
Measured: Baseline, Week 72
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline, Week 72
Number of Participants with Serious Adverse Events (SAEs)
Measured: Baseline, Week 72
Number of Participants with adverse events leading to discontinuation
Measured: Baseline, Week 72
Number of Participants with Adverse Events of Special Interest (AESIs)
Measured: Baseline, Week 72
Number of participants with absolute and change from baseline in laboratory measurements
Measured: Baseline, Week 72
Change from baseline in visceral fat area
Measured: Baseline, Week 72
Percentage of participants achieving the conversion to normoglycemia
Measured: Baseline, Week 72
Change from Baseline in Oral Glucose Tolerance Test (OGTT) 2h
Measured: Baseline, Week 72
Percentage of participants achieving conversion from HbA1c ≥7% to HbA1c <7%
Measured: Baseline, Week 72
Percentage of participants achieving conversion from >6.5% to HbA1c ≤6.5%
Measured: Baseline, Week 72
Percentage of participants achieving conversion from HbA1c ≥5.7% to HbA1c <5.7%
Measured: Baseline, Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start2 Oct 2026
- Primary completion14 Mar 2029 (estimated)
- Study completion14 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794761
- Sponsor's protocol ID
- C6491027
- Other IDs
- VESPER-JW
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.