VESPER-3

Active not recruitingPhase 2

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

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of Multiple Dose Regimens of Once-Weekly Switching to Once-Monthly MET097 in Participants With Obesity or Overweight (VESPER-3)

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

268

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 IDNCT06973720

Org study IDVESPER-3 (MET097-25-203)

Secondary IDC6491006Alias Study Number

Timeline

Milestones

Study start2025-04-07actual

Study first posted2025-05-15actual

Primary completion2025-12-16actual

Last update posted2026-05-29actual

Study completion2026-10-16estimated

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

3. 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

•Poorly controlled hypertension at, defined as any of the following:

–Mean seated systolic BP ≥160 mm Hg or mean seated diastolic BP ≥95 mm Hg at Screening visit

–A change in antihypertensive medications within 30 days of Screening visit

–Renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension at Screening; postural hypotension is defined as a sustained reduction of systolic blood pressure of at least 20 mmHg or diastolic blood pressure of 10 mmHg, with or without symptoms during the assessment, within three minutes of standing

•Thyroid-stimulating hormone (TSH) level lower than 0.4 mIU/L or higher than 6.0 mIU/L at the Screening visit. Note: participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 6 months

Endpoints (15)

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

10 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

Percent change from baseline in body weight at Week 64

Time frame:Baseline (Week 0) through Week 64 (Day 449)

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight at all other post-baseline weight measurements up to Week 64 other than Week 28

Time frame:Baseline (Week 0) through Week 24 (Day 169); Week 32 (Day 225) through Week 64 (Day 449)

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in absolute bodyweight (in kg) at all protocol-specified weekly and monthly post-baseline measurements

Time frame:Baseline (Week 0) through Week 64 (Day 449)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body mass index (BMI) at all protocol-specified weekly and monthly post-baseline measurements

Time frame:Baseline (Week 0) through Week 64 (Day 449)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference (in cm) at all protocol-specified weekly and monthly post-baseline measurements

Time frame:Baseline (Week 0) through Week 64 (Day 449)

change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight at post-treatment follow-up