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RecruitingNCT07794761Updated Nov 5, 2026

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 interventional study of Berobenatide and Placebo in Obesity, sponsored by Pfizer. Recruiting at 36 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Nov 5, 2026Now RecruitingSite recruiting status changed+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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 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.

02

Conditions studied

  • Obesity

Keywords

  • obesity
  • overweight
  • obesity disease
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 180 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged ≥18 years.
  • 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

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Treatment Arm 2

    Participants will receive berobenatide solution for injection as subcutaneous injection.

    Drug: Berobenatide

  • Placebo comparator
    Placebo

    Participants will receive placebo solution for injection as subcutaneous injection.

    Other: Placebo

  • Experimental
    Treatment Arm 3

    Participants will receive berobenatide solution for injection as subcutaneous injection.

    Drug: Berobenatide

  • Experimental
    Treatment Arm 1

    Participants will receive berobenatide solution for injection as subcutaneous injection.

    Drug: Berobenatide

Interventions

  • DrugBerobenatide

    Solution for injection

    Also known as: MET097, PF-08653944

  • OtherPlacebo

    Solution for injection

06

What researchers measure

Primary outcomes

  1. Percent change from baseline in body weight

    Time frame: Baseline, Week 72

Secondary outcomes

  1. Change from baseline in waist circumference

    Time frame: Baseline, Week 72

  2. Percentage of Participants achieving ≥10% of body weight reduction from baseline

    Time frame: Baseline, Week 72

  3. Percentage of Participants achieving ≥15% of body weight reduction from baseline

    Time frame: Baseline, Week 72

  4. Percentage of Participants achieving ≥20% of body weight reduction from baseline

    Time frame: Baseline, Week 72

  5. Percentage of Participants achieving ≥5% of body weight reduction from baseline

    Time frame: Baseline, Week 72

  6. Change from baseline in body weight

    Time frame: Baseline, Week 72

  7. Change from baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 72

  8. Change from baseline in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, Week 72

  9. 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

  10. Change from baseline in IWQoL-Lite-CT total score

    Time frame: Baseline, Week 72

  11. Change from baseline in IWQoL-Lite-CT Physical composite score

    Time frame: Baseline, Week 72

  12. Change from baseline in IWQoL-Lite-CT Psychosocial composite score

    Time frame: Baseline, Week 72

  13. Change from Baseline in Fasting Plasma Glucose

    Time frame: Baseline, Week 72

  14. Change from Baseline in Fasting Insulin

    Time frame: Baseline, Week 72

  15. Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)

    Time frame: Baseline, Week 72

  16. 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

  17. Change from Baseline in HbA1c

    Time frame: Baseline, Week 72

  18. Change from baseline in Fasting Total Cholesterol

    Time frame: Baseline, Week 72

  19. Change from baseline in Fasting Low-density lipoprotein cholesterol

    Time frame: Baseline, Week 72

  20. Change from baseline in Fasting Very low-density lipoprotein cholesterol

    Time frame: Baseline, Week 72

  21. Change from baseline in Fasting Non-High-density lipoprotein cholesterol

    Time frame: Baseline, Week 72

  22. Change from baseline in Fasting High-density lipoprotein cholesterol

    Time frame: Baseline, Week 72

  23. Change from baseline in Fasting triglycerides

    Time frame: Baseline, Week 72

  24. Change from baseline in high-sensitivity C-reactive protein

    Time frame: Baseline, Week 72

  25. Change from baseline in interleukin-6

    Time frame: Baseline, Week 72

  26. Change from baseline in interleukin-1 beta

    Time frame: Baseline, Week 72

  27. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Baseline, Week 72

  28. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Baseline, Week 72

  29. Number of Participants with adverse events leading to discontinuation

    Time frame: Baseline, Week 72

  30. Number of Participants with Adverse Events of Special Interest (AESIs)

    Time frame: Baseline, Week 72

  31. Number of participants with absolute and change from baseline in laboratory measurements

    Time frame: Baseline, Week 72

  32. Change from baseline in visceral fat area

    Time frame: Baseline, Week 72

  33. Percentage of participants achieving the conversion to normoglycemia

    Time frame: Baseline, Week 72

  34. Change from Baseline in Oral Glucose Tolerance Test (OGTT) 2h

    Time frame: Baseline, Week 72

  35. Percentage of participants achieving conversion from HbA1c ≥7% to HbA1c <7%

    Time frame: Baseline, Week 72

  36. Percentage of participants achieving conversion from >6.5% to HbA1c ≤6.5%

    Time frame: Baseline, Week 72

  37. Percentage of participants achieving conversion from HbA1c ≥5.7% to HbA1c <5.7%

    Time frame: Baseline, Week 72

07

Study locations

36 of 36 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Data sharing details ↗ · www.pfizer.com

09

Updates

3 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 15, 2026
Sites
26 sites added, 2 sites removed. 32 sites changed recruiting status (31 now recruiting, 1 now not yet recruiting)
Show 32 sites
  • Tenjin Sogo Clinic · Fukuoka, Japanno status→Recruiting
  • Medical Corporation BOOCS BOOCS CLINIC FUKUOKA · Fukuoka, Japanno status→Recruiting
  • Oishi Clinic · Kasuya-gun, Japanno status→Recruiting
  • Manda Memorial Hospital · Sapporo, Japanno status→Recruiting
  • Yamasaki Family Clinic · Amagasaki, Japanno status→Recruiting
  • Minami Akatsuka Clinic · Mito, Japanno status→Recruiting
  • Nishiyamado Keiwa Hospital · Naka, Japanno status→Recruiting
  • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic · Yokohama, Japanno status→Recruiting
  • Yokoi Clinic · Minoh, Japanno status→Recruiting
  • Kanemura Clinic · Osaka-shi Ikuno-ku, Japanno status→Recruiting
  • Medical Corporation Heishinkai OCROM Clinic · Suita, Japanno status→Recruiting
  • MI Clinic, Medical Corporation Jinsenkai · Toyonaka-shi, Japanno status→Recruiting
  • Soka Sugiura Internal medicine Clinic · Soka-shi, Japanno status→Recruiting
  • Doujin Memorial Foundation Meiwa Hospital · Chiyoda-ku, Japanno status→Recruiting
  • Aic Yaesu Clinic · Chuo-ku, Japanno status→Not yet recruiting
  • Tokyo Center Clinic · Chuo-ku, Japanno status→Recruiting
  • Tokyo-Eki Center-building Clinic · Chuo-ku, Japanno status→Recruiting
  • Fukuwa Clinic · Chuo-ku, Japanno status→Recruiting
  • Tokyo Asbo Clinic · Chuo-ku, Japanno status→Recruiting
  • Medical Corp. Seikoukai New Medical Research System Clinic · Hachioji-shi, Japanno status→Recruiting
  • Hachioji Clinic Shincho · Hachioji-shi, Japanno status→Recruiting
  • Keikokai Medical Corporation P-one Clinic · Hachiōji, Japanno status→Recruiting
  • Patient First Clinic Ginza-Shimbashi · Minato-ku, Japanno status→Recruiting
  • Shimamura Memorial Hospital · Nerima-ku, Japanno status→Recruiting
  • Medical Corporation Heishinkai ToCROM Clinic · Shinjuku-ku, Japanno status→Recruiting
  • Seeds Clinic Shinjuku-Sanchome, Eijinkai Medical Corporation · Shinjuku-ku, Japanno status→Recruiting
  • Higashi-Shinjuku Clinic, Keikokai Medical Corp. · Shinjuku-ku, Japanno status→Recruiting
  • Ikebukuro Metropolitan Clinic · Toshima-ku, Japanno status→Recruiting
  • Nihonbashi Sakura Clinic · Tokyo, Japanno status→Recruiting
  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism · Matsuyama, JapanNot yet recruiting→Recruiting
  • …and 2 more on the registry record
Show 26 added (26 Japan)
  • Tenjin Sogo Clinic · Fukuoka, Japan
  • Medical Corporation BOOCS BOOCS CLINIC FUKUOKA · Fukuoka, Japan
  • Yamasaki Family Clinic · Amagasaki, Japan
  • Minami Akatsuka Clinic · Mito, Japan
  • Nishiyamado Keiwa Hospital · Naka, Japan
  • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic · Yokohama, Japan
  • Yokoi Clinic · Minoh, Japan
  • Kanemura Clinic · Osaka-shi Ikuno-ku, Japan
  • MI Clinic, Medical Corporation Jinsenkai · Toyonaka-shi, Japan
  • Soka Sugiura Internal medicine Clinic · Soka-shi, Japan
  • Aic Yaesu Clinic · Chuo-ku, Japan
  • Tokyo Asbo Clinic · Chuo-ku, Japan
  • Medical Corp. Seikoukai New Medical Research System Clinic · Hachioji-shi, Japan
  • Hachioji Clinic Shincho · Hachioji-shi, Japan
  • Keikokai Medical Corporation P-one Clinic · Hachiōji, Japan
  • Patient First Clinic Ginza-Shimbashi · Minato-ku, Japan
  • Seeds Clinic Shinjuku-Sanchome, Eijinkai Medical Corporation · Shinjuku-ku, Japan
  • Tokuyama Clinic · Chiba, Japan
  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism · Matsuyama, Japan
  • Matsuyama Shimin Hospital · Matsuyama, Japan
  • Olive Takamatsu Medical Clinic · Takamatsu, Japan
  • AIC Yaesu Clinic · Chuo-ku, Japan
  • Tokuyama Clinic · Mihama-ku, Japan
  • Fukuoka Diagnostic Imaging Clinic Me-Well · Fukuoka, Japan
  • Mito Saiseikai General Hospital · Mito, Japan
  • Saiyu Soka Hospital · Soka-shi, Japan
Show 2 removed
  • Tokuyama Clinic · Chiba, Japan
  • Aic Yaesu Clinic · Chuo-ku, Japan
across 3 updates, Sep 25, 2026 – Nov 5, 2026
Start date
Sep 28, 2026→Oct 2, 2026 (actual)
Oct 15, 2026
Show all 3 updates
  1. Nov 5, 2026
    4 sites added, 2 sites removed. 16 sites changed recruiting status (16 now recruiting)
    Show 16 sites
    • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism · Matsuyama, JapanNot yet recruiting→Recruiting
    • Matsuyama Shimin Hospital · Matsuyama, JapanNot yet recruiting→Recruiting
    • Tenjin Sogo Clinic · Fukuoka, JapanNot yet recruiting→Recruiting
    • Medical Corporation BOOCS BOOCS CLINIC FUKUOKA · Fukuoka, JapanNot yet recruiting→Recruiting
    • Yamasaki Family Clinic · Amagasaki, JapanNot yet recruiting→Recruiting
    • Minami Akatsuka Clinic · Mito, JapanNot yet recruiting→Recruiting
    • Nishiyamado Keiwa Hospital · Naka, JapanNot yet recruiting→Recruiting
    • Olive Takamatsu Medical Clinic · Takamatsu, JapanNot yet recruiting→Recruiting
    • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic · Yokohama, JapanNot yet recruiting→Recruiting
    • Yokoi Clinic · Minoh, JapanNot yet recruiting→Recruiting
    • Kanemura Clinic · Osaka-shi Ikuno-ku, JapanNot yet recruiting→Recruiting
    • Soka Sugiura Internal medicine Clinic · Soka-shi, JapanNot yet recruiting→Recruiting
    • Tokyo-Eki Center-building Clinic · Chuo-ku, JapanNot yet recruiting→Recruiting
    • Fukuwa Clinic · Chuo-ku, JapanNot yet recruiting→Recruiting
    • Keikokai Medical Corporation P-one Clinic · Hachiōji, JapanNot yet recruiting→Recruiting
    • Patient First Clinic Ginza-Shimbashi · Minato-ku, JapanNot yet recruiting→Recruiting
    Show 4 added (4 Japan)
    • Tokuyama Clinic · Mihama-ku, Japan
    • Fukuoka Diagnostic Imaging Clinic Me-Well · Fukuoka, Japan
    • Mito Saiseikai General Hospital · Mito, Japan
    • Saiyu Soka Hospital · Soka-shi, Japan
    Show 2 removed
    • Tokuyama Clinic · Chiba, Japan
    • Aic Yaesu Clinic · Chuo-ku, Japan
    + 1 other change: verification date
  2. Oct 15, 2026
    Not yet recruiting→Recruiting
    5 sites added. 29 sites changed recruiting status (15 now recruiting, 14 now not yet recruiting)
    Show 29 sites
    • Tenjin Sogo Clinic · Fukuoka, Japanno status→Not yet recruiting
    • Medical Corporation BOOCS BOOCS CLINIC FUKUOKA · Fukuoka, Japanno status→Not yet recruiting
    • Oishi Clinic · Kasuya-gun, Japanno status→Recruiting
    • Manda Memorial Hospital · Sapporo, Japanno status→Recruiting
    • Yamasaki Family Clinic · Amagasaki, Japanno status→Not yet recruiting
    • Minami Akatsuka Clinic · Mito, Japanno status→Not yet recruiting
    • Nishiyamado Keiwa Hospital · Naka, Japanno status→Not yet recruiting
    • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic · Yokohama, Japanno status→Not yet recruiting
    • Yokoi Clinic · Minoh, Japanno status→Not yet recruiting
    • Kanemura Clinic · Osaka-shi Ikuno-ku, Japanno status→Not yet recruiting
    • Medical Corporation Heishinkai OCROM Clinic · Suita, Japanno status→Recruiting
    • MI Clinic, Medical Corporation Jinsenkai · Toyonaka-shi, Japanno status→Recruiting
    • Soka Sugiura Internal medicine Clinic · Soka-shi, Japanno status→Not yet recruiting
    • Doujin Memorial Foundation Meiwa Hospital · Chiyoda-ku, Japanno status→Recruiting
    • Aic Yaesu Clinic · Chuo-ku, Japanno status→Not yet recruiting
    • Tokyo Center Clinic · Chuo-ku, Japanno status→Recruiting
    • Tokyo-Eki Center-building Clinic · Chuo-ku, Japanno status→Not yet recruiting
    • Fukuwa Clinic · Chuo-ku, Japanno status→Not yet recruiting
    • Tokyo Asbo Clinic · Chuo-ku, Japanno status→Recruiting
    • Medical Corp. Seikoukai New Medical Research System Clinic · Hachioji-shi, Japanno status→Recruiting
    • Hachioji Clinic Shincho · Hachioji-shi, Japanno status→Recruiting
    • Keikokai Medical Corporation P-one Clinic · Hachiōji, Japanno status→Not yet recruiting
    • Patient First Clinic Ginza-Shimbashi · Minato-ku, Japanno status→Not yet recruiting
    • Shimamura Memorial Hospital · Nerima-ku, Japanno status→Recruiting
    • Medical Corporation Heishinkai ToCROM Clinic · Shinjuku-ku, Japanno status→Recruiting
    • Seeds Clinic Shinjuku-Sanchome, Eijinkai Medical Corporation · Shinjuku-ku, Japanno status→Recruiting
    • Higashi-Shinjuku Clinic, Keikokai Medical Corp. · Shinjuku-ku, Japanno status→Recruiting
    • Ikebukuro Metropolitan Clinic · Toshima-ku, Japanno status→Recruiting
    • Nihonbashi Sakura Clinic · Tokyo, Japanno status→Recruiting
    Show 5 added (5 Japan)
    • Tokuyama Clinic · Chiba, Japan
    • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism · Matsuyama, Japan
    • Matsuyama Shimin Hospital · Matsuyama, Japan
    • Olive Takamatsu Medical Clinic · Takamatsu, Japan
    • AIC Yaesu Clinic · Chuo-ku, Japan
    Start date Sep 28, 2026→Oct 2, 2026 (now actual)
    + 1 other change: verification date
  3. Sep 25, 2026
    17 sites added
    Show 17 added (17 Japan)
    • Tenjin Sogo Clinic · Fukuoka, Japan
    • Medical Corporation BOOCS BOOCS CLINIC FUKUOKA · Fukuoka, Japan
    • Yamasaki Family Clinic · Amagasaki, Japan
    • Minami Akatsuka Clinic · Mito, Japan
    • Nishiyamado Keiwa Hospital · Naka, Japan
    • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic · Yokohama, Japan
    • Yokoi Clinic · Minoh, Japan
    • Kanemura Clinic · Osaka-shi Ikuno-ku, Japan
    • MI Clinic, Medical Corporation Jinsenkai · Toyonaka-shi, Japan
    • Soka Sugiura Internal medicine Clinic · Soka-shi, Japan
    • Aic Yaesu Clinic · Chuo-ku, Japan
    • Tokyo Asbo Clinic · Chuo-ku, Japan
    • Medical Corp. Seikoukai New Medical Research System Clinic · Hachioji-shi, Japan
    • Hachioji Clinic Shincho · Hachioji-shi, Japan
    • Keikokai Medical Corporation P-one Clinic · Hachiōji, Japan
    • Patient First Clinic Ginza-Shimbashi · Minato-ku, Japan
    • Seeds Clinic Shinjuku-Sanchome, Eijinkai Medical Corporation · Shinjuku-ku, Japan

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07794761
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Oct 2, 2026
Primary completion
Mar 14, 2029 (estimated)
Completion
Mar 14, 2029 (estimated)
Last update
Nov 5, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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