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← All trials/NCT07876531

Not yet recruitingPhase 1

A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity

PHASE 1, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, PARALLEL GROUP, PK COMPARABILITY STUDY BETWEEN DIFFERENT DELIVERY SYSTEMS OF BEROBENATIDE IN ADULTS WITH OVERWEIGHT OR OBESITY

Lead sponsor

Pfizer

Asset

MET097 / PF-08653944

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

144

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 27-45

Primary endpoints

•AUC of Berobenatide•PK: Maximum Observed Concentration (Cmax) of Berobenatide

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07876531
Org study IDC6491017
Secondary ID2025
Secondary ID2025-524803-65-00CTIS (EU)

Timeline

Milestones

Study first posted2026-10-15actual
Last update posted2026-10-15actual
Study start2026-10-16estimated
Primary completion2027-04-06estimated
Study completion2027-04-06estimated

Assets

Investigational agents

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersAccepted

Eligibility criteria

Key Inclusion Criteria:

•Participants 18 years of age or older
•BMI of 27-45 kg/m2; and a total body weight >50 kg (110 lb)

Key Exclusion Criteria:

•Pregnant or breastfeeding women, or those planning pregnancy during the study
•History of other chronic disorders
•Personal or first-degree family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or suspected MTC
•Clinically significant gastric emptying abnormality or chronically taking drugs that directly affect gastrointestinal (GI) motility
•Acute GI symptoms at screening, Day -1, or prior to administration of study intervention

Endpoints (3)

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.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Berobenatide

Time frame:Up to 85 days

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Concentration (Cmax) of Berobenatide

Time frame:Up to 85 days

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Time frame:Up to 85 Days

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.