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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Placebo; Drug: Berobenatide

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Japan
  • Tokyo, Japan, 103-0025
    • Nihonbashi Sakura Clinic
  • Fukuoka
    • Kasuya-gun, Fukuoka, Japan, 811-2310
      • Oishi Clinic
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0062
      • Manda Memorial Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 101-0041
      • Doujin Memorial Foundation Meiwa Hospital
    • Chuo-ku, Tokyo, Japan, 103-0027
      • Tokyo-Eki Center-building Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Chuo-ku, Tokyo, Japan, 103-0027
      • Tokyo Center Clinic
    • Nerima-ku, Tokyo, Japan, 177-0051
      • Shimamura Memorial Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-0008
      • Medical Corporation Heishinkai ToCROM Clinic
    • Shinjuku-ku, Tokyo, Japan, 169-0072
      • Higashi-Shinjuku Clinic, Keikokai Medical Corp.
    • Toshima-ku, Tokyo, Japan, 171-0021
      • Ikebukuro Metropolitan Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm 1; Participants will receive berobenatide solution for injection as subcutaneous injection.	Drug: Berobenatide; Solution for injection; Other Names: PF-08653944; MET097
Experimental: Treatment Arm 2; Participants will receive berobenatide solution for injection as subcutaneous injection.	Drug: Berobenatide; Solution for injection; Other Names: PF-08653944; MET097
Experimental: Treatment Arm 3; Participants will receive berobenatide solution for injection as subcutaneous injection.	Drug: Berobenatide; Solution for injection; Other Names: PF-08653944; MET097
Placebo Comparator: Placebo; Participants will receive placebo solution for injection as subcutaneous injection.	Other: Placebo; Solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline in body weight	Baseline, Week 72

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Fasting Insulin	Baseline, Week 72
Change from Baseline in HbA1c	Baseline, Week 72
Change from baseline in body weight	Baseline, Week 72
Change from baseline in waist circumference	Baseline, Week 72
Percentage of Participants achieving ≥5% of body weight reduction from baseline	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
Change from baseline in Systolic Blood Pressure (SBP)	Baseline, Week 72
Change from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trial (IWQoL-Lite-CT) Physical Function composite score	Baseline, Week 72
Change from baseline in Diastolic Blood Pressure (DBP)	Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment insulin sensitivity as a percentage of normal (HOMA2-%S)	Baseline, Week 72
Change from Baseline in revised Homeostatic Model Assessment beta-cell function as a percentage of a normal reference population (HOMA2-%B)	Baseline, Week 72
Change from baseline in Fasting Total Cholesterol	Baseline, Week 72
Change from baseline in Fasting Low-density lipoprotein cholesterol	Baseline, Week 72
Change from baseline in Fasting Very low-density lipoprotein cholesterol	Baseline, Week 72
Change from baseline in Fasting Non-High-density lipoprotein cholesterol	Baseline, Week 72
Change from baseline in Fasting High-density lipoprotein cholesterol	Baseline, Week 72
Change from baseline in Fasting triglycerides	Baseline, Week 72
Change from baseline in high-sensitivity C-reactive protein	Baseline, Week 72
Change from baseline in interleukin-6	Baseline, Week 72
Change from baseline in interleukin-1 beta	Baseline, Week 72
Change from baseline in IWQoL-Lite-CT total score	Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Physical composite score	Baseline, Week 72
Change from baseline in IWQoL-Lite-CT Psychosocial composite score	Baseline, Week 72
Number of Participants with Adverse Events of Special Interest (AESIs)	Baseline, Week 72
Change from baseline in visceral fat area	Baseline, Week 72
Change from Baseline in Fasting Plasma Glucose	Baseline, Week 72
Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Baseline, Week 72
Number of Participants with Serious Adverse Events (SAEs)	Baseline, Week 72
Number of Participants with adverse events leading to discontinuation	Baseline, Week 72
Number of participants with absolute and change from baseline in laboratory measurements	Baseline, Week 72
Percentage of participants achieving the conversion to normoglycemia	Baseline, Week 72
Change from Baseline in Oral Glucose Tolerance Test (OGTT) 2h	Baseline, Week 72
Percentage of participants achieving conversion from HbA1c ≥7% to HbA1c <7%	Baseline, Week 72
Percentage of participants achieving conversion from >6.5% to HbA1c ≤6.5%	Baseline, Week 72
Percentage of participants achieving conversion from HbA1c ≥5.7% to HbA1c <5.7%	Baseline, Week 72

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Estimated): September 28, 2026
• Primary Completion (Estimated): March 14, 2029
• Study Completion (Estimated): March 14, 2029

Study Registration Dates

• First Submitted: August 26, 2026
• First Submitted That Met QC Criteria: August 26, 2026
• First Posted (Actual): August 31, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 3, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: obesity; overweight; obesity disease
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: C6491027; VESPER-JW (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes