Skip to main content
Delfa

← All trials/NCT07794761

RecruitingPhase 3

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)

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

36

Recruiting sites

36

Estimated enrollment

180

Study population

Obesity / overweight

Eligibility highlights

•BMI 27-35

Primary endpoint

•Body weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07794761
Org study IDC6491027
Secondary IDVESPER-JWAlias Study Number

Timeline

Milestones

Study first posted2026-08-31actual
Study start2026-10-02actual
Last update posted2026-11-05actual
Primary completion2029-03-14estimated
Study completion2029-03-14estimated

Assets

Investigational agents

MET097 / PF-08653944

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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).

Endpoints (38)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
9
Cardiometabolic biomarkers
9
Glycemic / diabetes
8
Other (unclassified)
7
Safety / tolerability / PK
5

Weight & body composition

9 endpoints
Primary/protocol endpoint

Percent change from baseline in body weight

Time frame:Baseline, Week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

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, improvement

Secondary/protocol endpoint

Change from baseline in visceral fat area

Time frame:Baseline, Week 72

change from baseline, improvement

Glycemic / diabetes

8 endpoints
Secondary/protocol endpoint

Change from Baseline in Fasting Plasma Glucose

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

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, improvement

Secondary/protocol endpoint

Change from Baseline in HbA1c

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

threshold achievement, improvement

Cardiometabolic biomarkers

9 endpoints
Secondary/protocol endpoint

Change from baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting Total Cholesterol

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting Low-density lipoprotein cholesterol

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting Very low-density lipoprotein cholesterol

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting High-density lipoprotein cholesterol

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting triglycerides

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in high-sensitivity C-reactive protein

Time frame:Baseline, Week 72

change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Time frame:Baseline, Week 72

event count, event

Secondary/protocol endpoint

Number of Participants with Serious Adverse Events (SAEs)

Time frame:Baseline, Week 72

event count, event

Secondary/protocol endpoint

Number of Participants with adverse events leading to discontinuation

Time frame:Baseline, Week 72

event count, event

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

event count, event

Secondary/protocol endpoint

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

Time frame:Baseline, Week 72

change from baseline, event

Other (unclassified)

7 endpoints
Secondary/protocol endpoint/low confidence

Change from baseline in IWQoL-Lite-CT total score

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in interleukin-6

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in interleukin-1 beta

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage of participants achieving the conversion to normoglycemia

Time frame:Baseline, Week 72

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.