DelfaGLP-1 Atlas

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RecruitingPhase 3

A Study to Learn About the Study Medicine (PF-08653944) in People With Obesity or Overweight and Type 2 Diabetes (T2D)

EVALUATING THE EFFICACY AND SAFETY OF MET097, A FULLY-BIASED ULTRA LONG-ACTING GLP-1RA, IN PEOPLE WITH OVERWEIGHT OR OBESITY AND TYPE 2 DIABETES: A PHASE 3, MULTI-CENTER RANDOMIZED PLACEBO-CONTROLLED TRIAL (VESPER-5)

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

183

Recruiting sites

47

Enrollment

999

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c ≥6.5%

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 IDNCT07400653
Org study IDC6491008
Secondary ID2025-523975-48-00CTIS (EU)
Secondary IDVESPER-5 (MET097-25-302)Alias Study Number

Timeline

Milestones

Study first posted2026-02-10actual
Study start2026-02-24actual
Last update posted2026-05-18actual
Primary completion2027-10-12estimated
Study completion2028-05-16estimated

Assets

Investigational agents

MET097 / PF-08653944

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Provision of signed and dated informed consent form (ICF)
•Male or female adults, aged ≥18 years
•Have a BMI at Screening of ≥27.0 kg/m2
•Have T2DM for at least 6 months before Screening based on participant reported history or documentation of the disease diagnostic criteria
•Have HbA1c value between ≥6.5% (48 mmol/mol) and ≤10.0% (86.0 mmol/mol) at Screening with stable therapy for at least 90 days prior to Screening/Visit 1. T2DM may be treated with:

--Diet and exercise alone or in combination with: Any oral antidiabetic therapy per local labeling EXCEPT DPP-4 inhibitors. Participant may NOT be on GLP-1 agonists or insulin

•Participants must be motivated and willing to:
–Self-inject study medication (or be aided by caregiver if needed),
–Perform finger-stick glucose monitoring as required.
•Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

•Female who is breastfeeding, or who is pregnant
•Unwilling or unable to follow contraceptive requirements
•Diagnosis of Type 1 diabetes, or any other types of diabetes except T2DM.
•Severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to Screening
•Poorly controlled hypertension
•Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
•Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) intended to promote weight loss
•Are receiving or have received within 3 months prior to screening chronic (>2 weeks or 14 days) systemic glucocorticoid therapy

Endpoints (33)

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

Cardiometabolic biomarkers
9
Weight & body composition
8
Glycemic / diabetes
6
Safety / tolerability / PK
6
Patient-reported / QoL
4

Weight & body composition

8 endpoints
Primary/protocol endpoint

Percent Change from baseline in body weight

Time frame:Baseline, Week 64

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in body weight

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants achieving ≥5% of body weight reduction from baseline

Time frame:Baseline, Week 64 and 84

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants achieving ≥10% of body weight reduction from baseline

Time frame:Baseline, Week 64 and 84

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants achieving ≥15% of body weight reduction from baseline

Time frame:Baseline, Week 64 and 84

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants achieving ≥20% of body weight reduction from baseline

Time frame:Baseline, Week 64 and 84

threshold achievement, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight

Time frame:Baseline, Week 84

percent change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Glycemic / diabetes

6 endpoints
Secondary/protocol endpoint

Change in HbA1c (%) from baseline

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <7%

Time frame:Week 64 and Week 84

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c ≤6.5%

Time frame:Week 64 and Week 84

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c <5.7%

Time frame:Week 64 and Week 84

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Fasting Glucose

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Fasting insulin

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Cardiometabolic biomarkers

9 endpoints
Secondary/protocol endpoint

Change from baseline in Fasting triglycerides

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Total Cholesterol

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Low-density lipoprotein cholesterol

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Very low-density lipoprotein cholesterol

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in High-density lipoprotein cholesterol

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Diastolic Blood Pressure (DBP)

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in high-sensitivity C-reactive protein

Time frame:Baseline, Week 64 and 84

percent change from baseline, improvement

Patient-reported / QoL

4 endpoints
Secondary/protocol endpoint

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

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Control of Eating Questionnaire (CoEQ)

Time frame:Baseline, Week 64 and 84

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Food Noise Questionnaire (FNQ)

Time frame:Baseline, Week 64 and 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

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.