CompletedPhase 1

A Study of How the Body Absorbs LY3537031

A Phase 1, 2-Part Study to Determine the Effect of Injection Site on the Relative Bioavailability of a Single Subcutaneous Dose of LY3537031 and to Evaluate the Pharmacokinetics of a Single Intravenous Dose of LY3537031 in Healthy Participants

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 18.5-35•Healthy volunteers

Primary endpoints

•AUC of LY3537031•Maximum Serum Observed Drug Concentration (Cmax) of LY3537031

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 IDNCT07202871

Org study ID27394

Secondary IDJ2S-MC-GZMNEli Lilly and Company

Timeline

Milestones

Study first posted2025-10-02actual

Study start2025-11-03actual

Primary completion2026-07-17actual

Study completion2026-07-17actual

Last update posted2026-07-23actual

Assets

Investigational agents

Brenipatide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age21 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Are overtly healthy as determined by medical evaluation including medical history and physical examination.

•Have a body weight of at least 45 kg.

•Have a Body Mass Index (BMI) within the range of 18.5 and 35.0 kg/m², inclusive

•Do not have skin aberrations that would preclude administration of the study drug at the planned injection sites.

Exclusion criteria

•Have significant history or current cardiovascular, respiratory, hepatic, renal, Gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.

•Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe post treatment hypersensitivity reactions, or have known allergies to LY3537031, Glucagon-Like Peptide-1 (GLP-1) analogs, or related compounds.

•Have undergone any form of bariatric surgery.

•Have a diagnosis or history of malignant disease within 5 years before screening, with the following (some exceptions are allowed)

•Have a history of or current acute or chronic pancreatitis, or elevation in serum lipase or amylase or both greater than 1.5× Upper Limit of Normal (ULN).

•Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, or any evidence for hepatic impairment.

•Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2.

Endpoints (2)

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

2 endpoints

Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3537031

Time frame:Day 1 Predose up to Day 64

concentration, descriptive

Primary/protocol endpoint

Pharmacokinetics (PK): Maximum Serum Observed Drug Concentration (Cmax) of LY3537031

Time frame:Day 1 Predose up to Day 64

concentration, descriptive

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.