CompletedPhase 1

A Study of LY3537031 in Healthy Participants

A Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics 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 19-35

Primary endpoint

•One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator

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 IDNCT04648865

Org study ID17756

Secondary IDJ2S-MC-GZMAEli Lilly and Company

Timeline

Milestones

Study first posted2020-12-02actual

Study start2020-12-09actual

Primary completion2021-06-04actual

Study completion2021-06-04actual

Last update posted2021-06-21actual

Assets

Investigational agents

Brenipatide

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age20 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Are male or female not of childbearing potential

•Have a body mass index (BMI) between 19 and 35 kilograms per square meter (kg/m²) and a body weight ≥ 54 kilograms (kg)

•Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study

•Have veins suitable for blood sampling

Exclusion criteria

•Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

•Have a diagnosis or history of cancer or malignant disease within 5 years

•Have been treated with prescription and over-the-counter medications that promote weight loss within 3 months prior to screening

•Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive

•Have undergone any form of bariatric surgery

•Have previously completed or withdrawn from this study

•Are currently participating in or completed a clinical trial within the last 3 months

•Regularly use known drugs of abuse or with positive drug results

•Smoke >10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during CRU admission

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

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline through final follow-up at approximately Day 43

event count, event

Secondary/protocol endpoint

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

Time frame:Baseline through final follow-up at approximately Day 43

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Concentration (Cmax) of LY3537031

Time frame:Baseline through final follow-up at approximately Day 43

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.