DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07595549

Not yet recruitingPhase 3

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

954

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-30

Primary endpoint

•Body weight

Identifiers

Registered as

NCT IDNCT07595549
Org study IDC6491013
Secondary ID2026-525318-75-00CTIS (EU)
Secondary IDVESPER-6Alias Study Number

Timeline

Milestones

Study first posted2026-05-19actual
Last update posted2026-05-27actual
Study start2026-06-30estimated
Primary completion2028-05-04estimated
Study completion2028-06-21estimated

Assets

Investigational agents

MET097 / PF-08653944

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Aged ≥18 years.
•BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to <30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.

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 (37)

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
11
Cardiometabolic biomarkers
9
Other (unclassified)
6
Glycemic / diabetes
4
Safety / tolerability / PK
4
Patient-reported / QoL
3

Weight & body composition

11 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 body weight

Time frame:Baseline, Week 72

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 ≥5% of body weight reduction from baseline

Time frame:Baseline, Week 72

threshold achievement, 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 with a waist-to-height ratio of <0.53

Time frame:Baseline, Week 72

threshold achievement, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight in participants with type 2 diabetes

Time frame:Baseline, Week 72

percent 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

Percentage of Participants achieving ≥25% of body weight reduction from baseline

Time frame:Baseline, Week 72

threshold achievement, improvement

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Change from Baseline in Fasting Glucose

Time frame:Basline, 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

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

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

Change from baseline in Short Form 36 health survey (SF-36) domain scales and component summary scales

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Control of Eating Questionnaire (CoEQ) subscales

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Food Noise Questionnaire (FNQ) total score

Time frame:Baseline, Week 72

change from baseline, improvement

Safety / tolerability / PK

4 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 avents 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

Other (unclassified)

6 endpoints
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

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 July 1, 2026 snapshot.