DelfaGLP-1 Atlas

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RecruitingPhase 1, PHASE2

A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes

A PHASE 1/2A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MET233 CO-ADMINISTERED WITH MET097 IN ADULT PARTICIPANTS WITH OBESITY OR OVERWEIGHT INCLUDING PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS

Lead sponsor

Pfizer

Assets

MET097 / PF-08653944 / MET233

Listed sites

1

Recruiting sites

1

Enrollment

381

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI 27-38

Primary endpoint

•Occurrence of treatment-emergent adverse events (TEAEs)

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 IDNCT06924320
Org study IDMET233/097-24-101
Secondary IDC6511001Alias Study Number

Timeline

Milestones

Study start2025-03-06actual
Study first posted2025-04-11actual
Last update posted2026-06-01actual
Primary completion2026-09-15estimated
Study completion2026-09-15estimated

Assets

Investigational agents

MET097 / PF-08653944MET233

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Adult males or females aged 18 to 75 years (inclusive) at the time of screening.
•BMI ≥27.0 kg/m2 and ≤38.0 kg/m2 (inclusive) at Screening for Parts A, B, and C, and ≥30.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts D and E. Have a BMI ≥27.0 kg/m2 and ≤45.0 kg/m2 (inclusive) at Screening for Parts G.
•Participants must be in generally stable health, as determined by the investigator based on medical history, physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
–Participants must have no clinically significant diseases or clinically significant findings on the physical examination (including vital signs), laboratory evaluations, and electrocardiogram (ECG).
–Participants in Parts C must not have clinically significant diseases except type 2 diabetes mellitus (T2DM), sleep apnea, well-controlled hypertension, and/or dyslipidemia.
–Participants in Parts E and G must not have any clinically significant diseases except hypertension, dyslipidemia, and/or a clinical diagnosis of sleep apnea.
•Willing and able to comply with all scheduled study visits, procedures, and required assessments.
•Women of childbearing potential must be willing to comply with protocol-specified contraceptive requirements and must not plan to become pregnant during the study.

Exclusion criteria

•Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1. Unwillingness or inability to comply with protocol-specified contraceptive requirements.
•Clinically significant abnormalities in laboratory results in the opinion of the investigator, increase risk or interfere with study participation.
•Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration.
•Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.
•Estimated glomerular filtration rate (eGFR) <80 mL/min at the Screening visit.
•Diagnosis of Type 1 diabetes.
•For Part A, Part B, Part D, Part E and Part G: Diagnosis of T2DM or glycated hemoglobin (HbA1c) > 6.4% or fasting plasma glucose >126 mg/dL at the Screening visit or history of taking any medications to lower glucose.
•For Part A, Part B and Part D: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.
•Use of prohibited prescription or non-prescription medications, supplements, or investigational products within protocol-defined washout periods.
•History or presence of clinically significant gastrointestinal, endocrine, respiratory, renal, hepatic, hematologic, neurologic, cardiovascular, psychiatric, immunologic, or other systemic diseases, except where explicitly permitted by the protocol.
•Personal or family history of medullary thyroid carcinoma, multiple endocrine neoplasia syndrome, pancreatitis, or pancreatic cancer.
•History of acute or chronic pancreatitis or pancreatic cancer.
•Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.
•History of bariatric or weight-loss surgery.
•Clinically significant psychiatric illness that may interfere with study participation or safety.
•Screening assessments indicative of moderate to severe depression.
•History of drug or alcohol abuse or dependence within the past 2 years.

Endpoints (18)

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
12
Safety / tolerability / PK
5
Other (unclassified)
1

Weight & body composition

12 endpoints
Secondary/protocol endpoint

Part A: Percent change from baseline in body weight at Day 8

Time frame:Baseline, Day 8

percent change from baseline, improvement

Secondary/protocol endpoint

Part A: Percent change from baseline in body weight at all other postbaseline weight measurements

Time frame:Part A (Baseline, Day 85)

percent change from baseline, improvement

Secondary/protocol endpoint

Part B and Part C: Percent change from baseline in body weight at Day 85

Time frame:Baseline, Day 85

percent change from baseline, improvement

Secondary/protocol endpoint

Part B and Part C: Percent change from baseline in body weight at all other postbaseline weight measurements

Time frame:Part B and Part C (Baseline, Day 155)

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight at Day 106

Time frame:Baseline, Day 106

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight at all other postbaseline weight measurements

Time frame:Part B and Part C (Baseline through Day 155)

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight at Day 113 and after QM dosing regimen complete

Time frame:Part D (Baseline, Day 113 and Day 169)

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight at all other postbaseline weight measurements

Time frame:Part D (Baseline through Day 218)

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight after QW dosing regimen complete and after QM dosing regimen complete

Time frame:Part E (Baseline, Day 141 and Day 197)

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight at all other postbaseline weight measurements

Time frame:Part E (Baseline through Day 246)

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight after QW dosing regimen complete and after QM dosing regimen complete

Time frame:Part G (Baseline, Day 113 and Day 225)

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change from baseline in body weight at all other postbaseline weight measurements

Time frame:Part G (Baseline through Day 274)

percent change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Occurrence of treatment-emergent adverse events (TEAEs)

Time frame:Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

descriptive

Secondary/protocol endpoint

Area under the concentration versus time curve extrapolated to infinity (AUCinf)

Time frame:Part A (Baseline, Day 85)

concentration, descriptive

Secondary/protocol endpoint

Area under the concentration versus time curve during the dosing interval (AUCtau)

Time frame:Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

concentration, descriptive

Secondary/protocol endpoint

Maximum observed concentration (Cmax)

Time frame:Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

concentration, descriptive

Secondary/protocol endpoint

Time to maximum observed concentration (Tmax)

Time frame:Part A (Baseline, Day 85), Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

time to event, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Minimum observed concentration (Cmin)

Time frame:Part B (Baseline, Day 155), Part C (Baseline, Day 155), Part D (Baseline, Day 218), Part E (Baseline, Day 246), Part G (Baseline, Day 274)

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.