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Active not recruitingPhase 1

A Study of LY3537031 in Overweight, Obese, and Healthy Participants

A Multiple-Ascending Dose Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of LY3537031 in Overweight and Obese Participants and Healthy Volunteers

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

5

Recruiting sites

-

Estimated enrollment

302

Study population

Obesity / overweight

Eligibility highlights

-

Primary endpoint

•One or More Treatment Emergent Adverse Events (TEAEs)

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 IDNCT06606106
Org study ID27199
Secondary IDJ2S-MC-GZMDEli Lilly and Company

Timeline

Milestones

Study start2024-09-05actual
Study first posted2024-09-20actual
Last update posted2026-09-30actual
Primary completion2026-11estimated (month precision)
Study completion2026-11estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age22 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Have a BMI within the range of:
-Parts A and D: 27.0 to 45.0 kilogram per square meter (kg/m²)
-Parts B and C: 22.0 to 26.9 kg/m²
•Parts B and C: Weigh 60 kg (80 pounds (lbs)) or more at screening
•Have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening
•Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.

Exclusion criteria

•Have undergone any form of bariatric surgery
•Participants who are lactating
•Have taken medications that promote weight loss within 90 days before screening
•Have a serum calcitonin level (at screening) of greater than or equal to 35 nanograms per liter (ng/L) (35 picograms per milliliter (pg/mL), 10.2 picomoles per liter (pmol/L))

Endpoints (12)

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
Glycemic / diabetes
5
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Pharmacodynamic (PD): Change from Baseline in Body Weight

Time frame:Baseline up to Week 56

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

PD: Change from Baseline in Fasting Glucose

Time frame:Baseline up to Week 56

change from baseline, improvement

Secondary/protocol endpoint

PD: Change from Baseline in Oral Glucose Tolerance Test (OGTT) Results

Time frame:Baseline up to Week 56

change from baseline, improvement

Secondary/protocol endpoint

PD: Change from Baseline in AUC of Glucose

Time frame:Baseline Up to Week 56

change from baseline, improvement

Secondary/protocol endpoint

PD: Change from Baseline in Insulin Levels

Time frame:Baseline Up to Week 56

change from baseline, improvement

Secondary/protocol endpoint

PD: Change from Baseline in Connecting Peptide (C-peptide) Levels

Time frame:Baseline Up to Week 56

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline to Study Completion (Up to 56 Weeks)

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3537031

Time frame:Predose on Day 1 through Week 56

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:Predose on Day 1 through Week 56

concentration, descriptive

Secondary/protocol endpoint

PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying

Time frame:Baseline up to Week 56

change from baseline, event

Secondary/protocol endpoint

PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying

Time frame:Baseline Up to Week 56

change from baseline, event

Secondary/protocol endpoint

PD: Change from Baseline in Time to Peak Drug Concentration (Tmax) of Acetaminophen to Assess the Delay in Gastric Emptying

Time frame:Baseline Up to Week 56

change from baseline, 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.