ObesityPhase 3NCT07794774
A Study to Learn About Safety and Effects of Once-monthly Treatment With Berobenatide in Adults With Obesity Disease in Japan (VESPER-JM)
A Phase 3 study testing Berobenatide in people with Obesity, run by Pfizer at 28 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 in which 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
- 197 participants
- Where
- 28 sitesJapan
- Study dates
- 28 Sep 2026to 21 Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
Japan28 sites
Yamasaki Family Clinic
Amagasaki, Hyōgo, 660- 0861
Aic Yaesu Clinic
Chuo-ku, Tokyo, 103-0027
Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0027
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
Tokyo Asbo Clinic
Chuo-ku, Tokyo, 104-0031
Tenjin Sogo Clinic
Fukuoka, Fukuoka, 810-0021
Medical Corporation BOOCS BOOCS CLINIC FUKUOKA
Fukuoka, Fukuoka, 812-0025
Keikokai Medical Corporation P-one Clinic
Hachiōji, Tokyo, 192-0071
Medical Corp. Seikoukai New Medical Research System Clinic
Hachioji-shi, Tokyo, 192-0046
Hachioji Clinic Shincho
Hachioji-shi, Tokyo, 192-0065
Oishi Clinic
Kasuya-gun, Fukuoka, 811-2310
Patient First Clinic Ginza-Shimbashi
Minato-ku, Tokyo, 105-0004
Yokoi Clinic
Minoh, Osaka, 562-0003
Minami Akatsuka Clinic
Mito, Ibaraki, 311-4153
Nishiyamado Keiwa Hospital
Naka, Ibaraki, 311-0133
Shimamura Memorial Hospital
Nerima-ku, Tokyo, 177-0051
Kanemura Clinic
Osaka-shi Ikuno-ku, Osaka, 544-0004
Manda Memorial Hospital
Sapporo, Hokkaido, 060-0062
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008
Seeds Clinic Shinjuku-Sanchome, Eijinkai Medical Corporation
Shinjuku-ku, Tokyo, 160-0022
Higashi-Shinjuku Clinic, Keikokai Medical Corp.
Shinjuku-ku, Tokyo, 169-0072
Soka Sugiura Internal medicine Clinic
Soka-shi, Saitama, 340-0015
Medical Corporation Heishinkai OCROM Clinic
Suita, Osaka, 565-0853
Nihonbashi Sakura Clinic
Tokyo, 103-0025
Ikebukuro Metropolitan Clinic
Toshima-ku, Tokyo, 171-0021
MI Clinic, Medical Corporation Jinsenkai
Toyonaka-shi, Osaka, 560-0004
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-MONTHLY BEROBENATIDE IN ADULTS WITH OBESITY DISEASE IN JAPAN (VESPER-JM)
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:
Read more
- 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.
- 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
Subcutaneous Injection
PlaceboOther
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Experimental | Participants will receive placebo solution for injection as subcutaneous injection. Receives: Other: Placebo |
| Treatment Arm 1 | Experimental | Participants will receive berobenatide solution for injection as subcutaneous injection. Receives: Drug: Berobenatide |
| Treatment Arm 2 | Experimental | Participants will receive berobenatide solution for injection as subcutaneous injection. Receives: Drug: Berobenatide |
| Treatment Arm 3 | Experimental | Participants will receive berobenatide solution for injection as subcutaneous injection. Receives: Drug: Berobenatide |
| Treatment Arm 4 | 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 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: Week 72
Number of participants with Serious Adverse Events (SAEs)
Measured: Week 72
Number of participants with adverse events leading to discontinuation
Measured: Week 72
Number of participants with Adverse Events of Special Interest (AESIs)
Measured: Week 72
Number of participants with absolute and change from baseline in laboratory measurements
Measured: Week 72
Change from baseline in visceral fat area
Measured: Baseline, Week 72
Percentage of participants achieving visceral fat area <100 cm2
Measured: Week 72
Percentage of participants achieving the conversion to normoglycemia
Measured: 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: Week 72
Percentage of participants achieving conversion from HbA1c ≥5.7% to HbA1c <5.7%
Measured: 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 start28 Sep 2026 (estimated)
- Primary completion21 Feb 2029 (estimated)
- Study completion21 Feb 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
- 197 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
- NCT07794774
- Sponsor's protocol ID
- C6491033
- Other IDs
- VESPER-JM
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 25 Sep 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07794774
- Acronym / sponsor ID
- C6491033
- Conditions
- Obesity
- Keywords
- obesity, overweight, obesity disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 197 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 21 Feb 2029 (estimated)
- Study completion
- 21 Feb 2029 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Experimental | Other: PlaceboParticipants will receive placebo solution for injection as subcutaneous injection. |
| Treatment Arm 1 | Experimental | Drug: BerobenatideParticipants will receive berobenatide solution for injection as subcutaneous injection. |
| Treatment Arm 2 | Experimental | Drug: BerobenatideParticipants will receive berobenatide solution for injection as subcutaneous injection. |
| Treatment Arm 3 | Experimental | Drug: BerobenatideParticipants will receive berobenatide solution for injection as subcutaneous injection. |
| Treatment Arm 4 | Experimental | Drug: BerobenatideParticipants will receive berobenatide solution for injection as subcutaneous injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BerobenatideAlso: MET097, PF-08653944Subcutaneous Injection | Drug | Treatment Arm 1, Treatment Arm 2, Treatment Arm 3, Treatment Arm 4 |
| PlaceboSubcutaneous Injection | Other | Placebo |
Primary outcome
Percent change from baseline in body weight
Time frame: Baseline, Week 72
37 secondary outcomes
Change from baseline in waist circumference
Time frame: Baseline, Week 72
Percentage of participants achieving ≥10% of body weight reduction from baseline
Time frame: Baseline, Week 72
Percentage of participants achieving ≥15% of body weight reduction from baseline
Time frame: Baseline, Week 72
Percentage of participants achieving ≥20% of body weight reduction from baseline
Time frame: Baseline, Week 72
Percentage of participants achieving ≥5% of body weight reduction from baseline
Time frame: Baseline, Week 72
Change from baseline in body weight
Time frame: Baseline, Week 72
Change from baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 72
Change from baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 72
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score
Time frame: Baseline, Week 72
Change from baseline in IWQoL-Lite-CT total score
Time frame: Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Physical composite score
Time frame: Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Psychosocial composite score
Time frame: Baseline, Week 72
Change from baseline in fasting glucose
Time frame: Baseline, Week 72
Change from baseline in fasting insulin
Time frame: Baseline, Week 72
Change from baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)
Time frame: Baseline, Week 72
Change from baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)
Time frame: Baseline, Week 72
Change from baseline in HbA1c
Time frame: Baseline, Week 72
Change from baseline in fasting total cholesterol
Time frame: Baseline, Week 72
Change from baseline in fasting low-density lipoprotein cholesterol
Time frame: Baseline, Week 72
Change from baseline in fasting very low-density lipoprotein cholesterol
Time frame: Baseline, Week 72
Change from baseline in fasting non-high-density lipoprotein cholesterol
Time frame: Baseline, Week 72
Change from baseline in fasting high-density lipoprotein cholesterol
Time frame: Baseline, Week 72
Change from baseline in fasting triglycerides
Time frame: Baseline, Week 72
Change from baseline in high-sensitivity C-reactive protein
Time frame: Baseline, Week 72
Change from baseline in interleukin-6
Time frame: Baseline, Week 72
Change from baseline in interleukin-1 beta
Time frame: Baseline, Week 72
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Week 72
Number of participants with Serious Adverse Events (SAEs)
Time frame: Week 72
Number of participants with adverse events leading to discontinuation
Time frame: Week 72
Number of participants with Adverse Events of Special Interest (AESIs)
Time frame: Week 72
Number of participants with absolute and change from baseline in laboratory measurements
Time frame: Week 72
Change from baseline in visceral fat area
Time frame: Baseline, Week 72
Percentage of participants achieving visceral fat area <100 cm2
Time frame: Week 72
Percentage of participants achieving the conversion to normoglycemia
Time frame: Week 72
Change from baseline in Oral Glucose Tolerance Test (OGTT) 2h
Time frame: Baseline, Week 72
Percentage of participants achieving conversion from HbA1c ≥7% to HbA1c <7%
Time frame: Week 72
Percentage of participants achieving conversion from HbA1c ≥5.7% to HbA1c <5.7%
Time frame: Week 72
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Berobenatide in people with Obesity, run by Pfizer at 28 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in body weight (time frame: Baseline, Week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.