DelfaGLP-1 Atlas

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CompletedPhase 1, PHASE2

This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity

A Phase 1/2 Randomized Placebo-Controlled Double-Blind Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Doses of MET097 in Adult Participants With Obesity and Overweight But Otherwise Healthy

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

3

Recruiting sites

—

Enrollment

120

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 27-38•eGFR ≥90•Healthy volunteers

Primary endpoint

•(Part C) Percent change from baseline in 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 IDNCT06857617
Org study IDMET097-23-101

Timeline

Milestones

Study start2024-04-01actual
Primary completion2025-01-03actual
Study first posted2025-03-04actual
Study completion2025-03-15actual
Last update posted2026-01-28actual

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 volunteersAccepted

Inclusion criteria

•Overweight/Obese but otherwise healthy adult male or female with a BMI within 27.0 kg/m2 to 38.0 kg/m2, inclusively
•At least 18 years of age but not older than 70 years of age
•Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator
•Estimated glomerular filtration rate (eGFR) ≥90 mL/min at the Screening visit

Exclusion criteria

•Female who is lactating or who is pregnant according to the pregnancy test at the Screening visit or prior to the first study drug administration
•Seated blood pressure higher than 160/95 mmHg at the Screening visit
•Elevated resting pulse greater than 100 beats per minute at Screening visit
•Presence of clinically significant ECG abnormalities
•Diagnosis of diabetes (type 1 or type 2)
•Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration
•Obesity induced by endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome).
•Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type

Endpoints (7)

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

Safety / tolerability / PK
6
Weight & body composition
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

(Part C) Percent change from baseline in body weight at Week 12 (Day 85).

Time frame:Day 1 (Week 0) to Day 85 (Week 12)

percent change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

(Part C) To characterize the maximum observed concentration (Cmax).

Time frame:Day 1 (Week 0) to Day 160 (Week 31)

concentration, descriptive

Secondary/protocol endpoint

(Part C) To characterize the time of maximum observed concentration (Tmax).

Time frame:Day 1 (Week 0) to Day 160 (Week 31)

concentration, descriptive

Secondary/protocol endpoint

(Part C) To characterize the area under the concentration versus time curve (AUC).

Time frame:Day 1 (Week 0) to Day 160 (Week 31)

concentration, descriptive

Secondary/protocol endpoint

(Part C) To characterize the elimination half-life (t1/2).

Time frame:Day 1 (Week 0) to Day 160 (Week 31)

concentration, descriptive

Secondary/protocol endpoint

(Part C) Occurrence of treatment-emergent adverse events (TEAEs) through Week 12.

Time frame:Day 1 (Week 0) to Day 85 (Week 12)

descriptive

Secondary/protocol endpoint

(Part C) Occurrence of TEAEs following the 13th dose.

Time frame:Day 85 (Week 12) to Day 160 (Week 31)

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.