DelfaGLP-1 Atlas

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VESPER-4

RecruitingPhase 3

Efficacy and Safety of MET097 Once-Weekly in People With Overweight or Obesity

Evaluating The Efficacy and Safety of MET097, a Fully-Biased, Ultra Long-Acting GLP-1RA, In People With Overweight or Obesity: A Phase 3, Multi-Center Randomized, Controlled Trial (VESPER-4)

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

195

Recruiting sites

31

Enrollment

3,501

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-30

Primary endpoint

•Body weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07311850
Org study IDVESPER-4 (MET097-25-301)
Secondary ID2025-523974-18-00CTIS (EU)
Secondary IDC6491007Alias Study Number

Timeline

Milestones

Study start2025-12-19actual
Study first posted2025-12-31actual
Last update posted2026-05-29actual
Primary completion2027-09-21estimated
Study completion2028-04-25estimated

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

•BMI ≥ 30 kg/m2 or BMI ≥ 27.0 kg/m2 to <30.0 kg/m2 and presence of at least 1 of the following weight- related comorbidities: Hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease)

Exclusion criteria

•Have any form of diabetes
•Have a self-reported body weight change > 5 kg (11 pounds) within 3 months prior to Screening
•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
•History of chronic pancreatitis or presence of acute pancreatitis within the past 180 days prior to the Screening visit; or active/current, symptomatic gallbladder disease

Endpoints (39)

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
13
Cardiometabolic biomarkers
11
Safety / tolerability / PK
6
Patient-reported / QoL
5
Glycemic / diabetes
3
Other (unclassified)
1

Weight & body composition

13 endpoints
Primary/protocol endpoint

Percent change from baseline in body weight

Time frame:Baseline (Day 0) to Week 64

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants who achieve ≥5% of reduction from baseline body weight

Time frame:Baseline (Day 0) to Week 64

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who achieve ≥10% of reduction from baseline body weight

Time frame:Baseline (Day 0) to Week 64

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who achieve ≥15% of reduction from baseline body weight

Time frame:Baseline (Day 0) to Week 64

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who achieve ≥20% of reduction from baseline body weight

Time frame:Baseline (Day 0) to Week 64

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Baseline (Day 0) to Week 84

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants who achieve ≥5% of reduction from baseline body weight

Time frame:Baseline (Day 0) to Week 84

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who achieve ≥10% of reduction from baseline body weight

Time frame:Baseline (Day 0) to Week 84

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who achieve ≥15% of reduction from baseline body weight

Time frame:Baseline (Day 0) to Week 84

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants who achieve ≥20% of reduction from baseline body weight

Time frame:Baseline (Day 0) to Week 84

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference (cm)

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Baseline (Day 0) to Week 64

change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight

Time frame:Baseline (Day 0) to Week 84

percent change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change from baseline in glycated hemoglobin (HbA1c)

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (FPG)

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting insulin

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Cardiometabolic biomarkers

11 endpoints
Secondary/protocol endpoint

Change from baseline in Fasting triglycerides

Time frame:Baseline (Day 0) to Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C) (mg/dL)

Time frame:Baseline (Day 0) to Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in systolic blood pressure

Time frame:Baseline (Day 0) to Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Fasting triglycerides

Time frame:Baseline (Day 0) to Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in non-high-density lipoprotein-cholesterol (non-HDL-C)

Time frame:Baseline (Day 0) to Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in systolic blood pressure (mmHg)

Time frame:Baseline (Day 0) to Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in total cholesterol

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in low-density lipoprotein-cholesterol (LDL-C)

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in very low-density lipoprotein-cholesterol (VLDL-C)

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in high-density lipoprotein-cholesterol (HDL-C)

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in high-sensitivity C-reactive protein (hs-CRP)

Time frame:Baseline (Day 0) to Week 64 and Week 84

percent change from baseline, improvement

Patient-reported / QoL

5 endpoints
Secondary/protocol endpoint

Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score

Time frame:Baseline (Day 0) to Week 64

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in the Short Form 36 health survey (SF-36) physical function domain score

Time frame:Baseline (Day 0) to Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in EuroQoL 5-Dimension 5-Level (EQ5D-5L)

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Control of Eating Questionnaire (CoEQ)

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Food Noise Questionnaire (FNQ)

Time frame:Baseline (Day 0) to Week 64 and Week 84

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame:Week 84

event count, event

Secondary/protocol endpoint

Number of Participants with Serious adverse events (SAEs)

Time frame:Week 84

event count, event

Secondary/protocol endpoint

Number of Participants with Adverse Events of Clinical Interest (AECIs

Time frame:Week 84

event count, event

Secondary/protocol endpoint

Number of Participants With Clinical Laboratory Abnormalities

Time frame:Week 84

event count, event

Secondary/protocol endpoint

Number of participants with anti-drug antibodies (ADAs)

Time frame:Week 84

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of PF-08653944

Time frame:Week 84

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline in DBP

Time frame:Baseline (Day 0) to Week 64 and Week 84

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.