DelfaGLP-1 Atlas

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VESPER-2

CompletedPhase 2

A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM

A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight, and Type 2 Diabetes Mellitus (VESPER-2)

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

29

Recruiting sites

—

Enrollment

133

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 27-50•HbA1c ≥7%

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 IDNCT06897202
Org study IDVESPER-2 (MET097-24-202)
Secondary IDC6491005Pfizer

Timeline

Milestones

Study start2025-03-14actual
Study first posted2025-03-26actual
Primary completion2025-12-29actual
Study completion2026-03-18actual
Last update posted2026-05-29actual

Assets

Investigational agents

MET097 / PF-08653944

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•BMI ≥27.0 kg/m2 to ≤50.0 kg/m2 at screening
•Type 2 diabetes mellitus (*T2DM) for at least 3 months before screening
•Glycated hemoglobin (HbA1c) value between ≥7.0% (53.0 mmol/mol) and ≤10.5% (91.3 mmol/mol) at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1 (diet and exercise alone or in combination with metformin monotherapy and/or SGLT-2)
•Stable body weight (increase or decrease ≤5 kg) within 3 months prior to screening

Exclusion criteria

•Female who is lactating or who is pregnant
•Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2
•Fasting triglycerides ≥ 5.6 mmol/L (≥500 mg/dL)
•Poorly controlled hypertension
•History of stroke
•Significant cardiovascular disease including but not limited to unstable angina or valvular heart disease or has a history of myocardial infarction, coronary artery bypass graft, percutaneous coronary artery re-vascularization, or congestive heart failure
•Diagnosis of Type 1 diabetes (history of ketoacidosis, hyperosmolar state/coma, or any other types of diabetes except T2DM)
•History of acute or chronic 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
•Relevant surgical history including all bariatric or weight loss surgeries
•SGLT2 inhibitors and/or metformin
•Had 1 or more episodes of hypoglycemia

Endpoints (21)

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

Glycemic / diabetes
8
Safety / tolerability / PK
5
Weight & body composition
4
Other (unclassified)
3
Cardiometabolic biomarkers
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percent change from baseline in body weight at Week 28 (Day 197)

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

Glycemic / diabetes

8 endpoints
Secondary/protocol endpoint

Change in glycated hemoglobin A1c (HbA1c)

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

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (FPG)

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

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting serum insulin

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

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in C-peptide

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

change from baseline, improvement

Secondary/protocol endpoint

Occurrence of HbA1c <7.0% (53.0 mmol/mol)

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

descriptive

Secondary/protocol endpoint

Occurrence of HbA1c ≤6.5% (47.5 mmol/mol)

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

descriptive

Secondary/protocol endpoint

Occurrence of HbA1c <5.7% (38.8 mmol/mol)

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

descriptive

Secondary/protocol endpoint

Occurrence of hypoglycemia according to American Diabetes Association classifications [ADA 2024]

Time frame:Baseline (Week 0) through Week 39 (Day 274)

descriptive

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change from baseline in high-sensitivity C-reactive Protein [hsCRP]

Time frame:Baseline (Week 0) through Week 39 (Day 274)

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 39 (Day 274)

descriptive

Secondary/protocol endpoint

Occurrence of anti-drug antibodies

Time frame:Baseline (Week 0) through Week 39 (Day 274)

descriptive

Secondary/protocol endpoint

Characterize the maximum observed concentration (Cmax)

Time frame:Baseline (Week 0) through Week 39 (Day 274)

concentration, descriptive

Secondary/protocol endpoint

Characterize the area under the concentration versus time curve (AUC)

Time frame:Baseline (Week 0) through Week 39 (Day 274)

concentration, descriptive

Secondary/protocol endpoint

Characterize the time to maximum concentration (Tmax)

Time frame:Baseline (Week 0) through Week 39 (Day 274)

time to event, event

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Change from baseline in serum albumin

Time frame:Baseline (Week 0) through Week 39 (Day 274)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in transthyretin [pre-albumin]

Time frame:Baseline (Week 0) through Week 39 (Day 274)

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Characterize the minimum observed concentration (Cmin)

Time frame:Baseline (Week 0) through Week 39 (Day 274)

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.