VESPER-1

CompletedPhase 2

A Phase 2b Study to Examine the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of 28 Weeks to Investigate the Safety and Efficacy of Once-Weekly MET097 in Adults With Obesity or Overweight Followed by a 32-Week Extension (VESPER-1)

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

239

actual

Study population

Obesity / overweight

Key I/E criterion

—

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 IDNCT06712836

Org study IDVESPER-1 (MET097-24-201)

Secondary IDC6491004Alias Study Number

Timeline

Milestones

Study start2024-10-09actual

Study first posted2024-12-02actual

Primary completion2025-07-03actual

Study completion2026-04-30actual

Last update posted2026-05-29actual

Assets

Investigational agents

MET097 / PF-08653944

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Body mass index (BMI) at Screening of:

–BMI ≥30 kg/m2 and ≤50.0 kg/m2 (can have the weight-related co-morbidities listed below)

–BMI ≥27.0 kg/m2 to <30.0 kg/m2 with at least one of the following weight-related co-morbidities:

1. Hypertension: on blood pressure (BP)-lowering medication or having systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg at Screening

2. Dyslipidemia: on lipid-lowering medication or having low-density lipoprotein cholesterol (LDL-C) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein-cholesterol (HDL-C) <40 mg/dL (1.0 mmol/L) for men or HDL-C <50 mg/dL (1.3 mmol/L) for women at Screening

Stable body weight (increase or decrease ≤5 kg) within 3 months prior to Screening

Exclusion criteria

•Diagnosis of diabetes (T1DM or T2DM) or glycated hemoglobin A1c (HbA1c) ≥ 6.5% or fasting plasma glucose >125 mg/dL.

•Estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m2

•History of pancreatitis

•Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

•History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years

•Any lifetime history of a suicide attempt.

Endpoints (14)

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

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

8 endpoints

Primary/protocol endpoint

Percent change from baseline in body weight at Week 28

Time frame:Baseline (Week 0) through Week 28 (Day 197)

percent change from baseline, improvement

Secondary/protocol endpoint

Weight reduction (weight loss) from baseline that is ≥ 5%

Time frame:Baseline (Week 0) through Week 28 (Day 197)

threshold achievement, improvement

Secondary/protocol endpoint

Weight reduction (weight loss) from baseline that is ≥ 10%

Time frame:Baseline (Week 0) through Week 28 (Day 197)

threshold achievement, improvement

Secondary/protocol endpoint

Weight reduction (weight loss) from baseline that is ≥ 15%

Time frame:Baseline (Week 0) through Week 28 (Day 197)

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body weight (kg)

Time frame:Baseline (Week 0) through Week 28 (Day 197)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body mass index (BMI)

Time frame:Baseline (Week 0) through Week 28 (Day 197)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference

Time frame:Baseline (Week 0) through Week 28 (Day 197)

change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight at all protocol-specified post-baseline measurements during the exploratory extension study

Time frame:Week 28 to Week 60

percent change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Occurrence of treatment emergent adverse events (TEAEs)

Time frame:Baseline (Week 0) through Week 37 (Day 265)

descriptive

Secondary/protocol endpoint

Area under the concentration versus time curve during the dosing interval (AUC(0-τ))

Time frame:Baseline (Week 0) through Week 31 (Day 220)

concentration, descriptive

Secondary/protocol endpoint

Maximum observed concentration (Cmax)

Time frame:Baseline (Week 0) through Week 31 (Day 220)

concentration, descriptive

Secondary/protocol endpoint

Time to maximum concentration (Tmax)

Time frame:Baseline (Week 0) through Week 31 (Day 220)

time to event, event

Secondary/protocol endpoint

Occurrence of treatment emergent adverse events (TEAEs) during the exploratory extension study

Time frame:Week 28 to Week 60

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Minimum observed concentration (Cmin)

Time frame:Baseline (Week 0) through Week 28 (Day 197)

concentration, descriptive

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.