ClinicalTrials.gg
RecruitingNCT07794774Updated Nov 6, 2026

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 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 2026-11-06.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 6, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
197
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies testing berobenatide in Obesity — 10 open to participants now, 14 under way, 11 of them phase 3. berobenatide · Obesity.

Planned enrollment
13th of 20
197 · median 249
Started
2026
with 13 others
Phase 3
11 of 20
9 open now
Primary completion
2029-02
later than 12 of 13 live
Registered
12th of 20
by date
Lead sponsor
19 of 20
Pfizer

Among the 20 studies testing berobenatide in Obesity, this one is the 13th largest by planned enrollment, is one of 14 that started in 2026, is one of 11 in phase 3, reaches primary completion later than 12 of the 13 other live ones, and was the 12th registered.

By phase

20 studies; the count open now beside each. This study's row is marked.

Phase 3this study11 · 9 open
Phase 14 · 1 open
Phase 23 · 0 open
Phase 1/22 · 0 open

By the year they started

First in 2024; this study’s year is marked. 14 started in 2026.

Tested beside berobenatide

Size and results

Median enrollment 249 across the 20 interventional studies. Of the 6 that completed or were terminated, 1 (17%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 20 studies testing berobenatide in Obesity, or all of them as a file.
02

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.

03

Conditions studied

  • Obesity

Keywords

  • obesity
  • overweight
  • obesity disease
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
197 participants (estimated)

Study arms

  • Experimental
    Treatment Arm 1

    Participants will receive berobenatide solution for injection as subcutaneous injection.

    Drug: Berobenatide

  • Experimental
    Placebo

    Participants will receive placebo solution for injection as subcutaneous injection.

    Other: Placebo

  • Experimental
    Treatment Arm 2

    Participants will receive berobenatide solution for injection as subcutaneous injection.

    Drug: Berobenatide

  • Experimental
    Treatment Arm 3

    Participants will receive berobenatide solution for injection as subcutaneous injection.

    Drug: Berobenatide

  • Experimental
    Treatment Arm 4

    Participants will receive berobenatide solution for injection as subcutaneous injection.

    Drug: Berobenatide

Interventions

  • Subcutaneous Injection

    Also known as: MET097, PF-08653944

  • OtherPlacebo

    Subcutaneous 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 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: Week 72

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

    Time frame: Week 72

  29. Number of participants with adverse events leading to discontinuation

    Time frame: Week 72

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

    Time frame: Week 72

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

    Time frame: Week 72

  32. Change from baseline in visceral fat area

    Time frame: Baseline, Week 72

  33. Percentage of participants achieving visceral fat area <100 cm2

    Time frame: Week 72

  34. Percentage of participants achieving the conversion to normoglycemia

    Time frame: Week 72

  35. Change from baseline in Oral Glucose Tolerance Test (OGTT) 2h

    Time frame: Baseline, Week 72

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

    Time frame: Week 72

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

    Time frame: Week 72

07

Study locations

34 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

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 6, 2026
Sites
25 sites added. 28 sites changed recruiting status (27 now recruiting, 1 now not yet recruiting)
Show 28 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→Not yet 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
  • Aic Yaesu Clinic · Chuo-ku, Japanno status→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
Show 25 added (25 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 · Mihama-ku, Japan
  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism · Matsuyama, Japan
  • Matsuyama Shimin Hospital · Matsuyama, Japan
  • Fukuoka Diagnostic Imaging Clinic Me-Well · Fukuoka, Japan
  • Mito Saiseikai General Hospital · Mito, Japan
  • Olive Takamatsu Medical Clinic · Takamatsu, Japan
  • Saiyu Soka Hospital · Soka-shi, Japan
  • Doujin Memorial Foundation Meiwa Hospital · Chiyoda-ku, Japan
across 2 updates, Sep 25, 2026 – Nov 6, 2026
Start date
Sep 28, 2026→Sep 29, 2026 (actual)
Nov 6, 2026
Show all 2 updates
  1. Nov 6, 2026
    Not yet recruiting→Recruiting
    8 sites added. 28 sites changed recruiting status (27 now recruiting, 1 now not yet recruiting)
    Show 28 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→Not yet 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
    • Aic Yaesu Clinic · Chuo-ku, Japanno status→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
    Show 8 added (8 Japan)
    • Tokuyama Clinic · Mihama-ku, Japan
    • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism · Matsuyama, Japan
    • Matsuyama Shimin Hospital · Matsuyama, Japan
    • Fukuoka Diagnostic Imaging Clinic Me-Well · Fukuoka, Japan
    • Mito Saiseikai General Hospital · Mito, Japan
    • Olive Takamatsu Medical Clinic · Takamatsu, Japan
    • Saiyu Soka Hospital · Soka-shi, Japan
    • Doujin Memorial Foundation Meiwa Hospital · Chiyoda-ku, Japan
    Start date Sep 28, 2026→Sep 29, 2026 (now actual)
    + 1 other change: verification date
  2. 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
NCT07794774
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Aug 31, 2026
Start date
Sep 29, 2026
Primary completion
Feb 21, 2029 (estimated)
Completion
Feb 21, 2029 (estimated)
Last update
Nov 6, 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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Studies of the drug tested here: Berobenatide

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