RecruitingPhase 1

A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function

A Phase 1, Multicenter, Parallel-Design, Single Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Eloralintide in Participants With Severe Renal Impairment and End Stage Renal Disease (ESRD) Compared With Participants With Normal Renal Function

Lead sponsor

Eli Lilly and Company

Asset

Eloralintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

Estimated enrollment

Study population

Healthy volunteers, Renal impairment

Eligibility highlights

•BMI 19-40•HbA1c ≤6.5%•eGFR ≥90•Healthy volunteers

Primary endpoints

•AUC From Zero to Infinity AUC(0-∞) of LY3841136•PK: Maximum Observed Drug Concentration (Cmax) of LY3841136

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 IDNCT07426380

Org study ID27752

Secondary IDJ3R-MC-YDAJEli Lilly and Company

Timeline

Milestones

Study first posted2026-02-23actual

Study start2026-02-24actual

Last update posted2026-03-13actual

Primary completion2026-10estimated (month precision)

Study completion2026-10estimated (month precision)

Assets

Investigational agents

Eloralintide

Who this study enrolls

Healthy volunteersRenal impairment

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Have a body weight of 55 kilograms (kg) or more and a body mass index (BMI) within the range of 19.0 to 40.0 kilograms per square meter (kg/m²), inclusive

•Have no significant history of spontaneous or ethanol-induced hypoglycemia

Additional Inclusion Criteria for Group 1

•Are healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) of at least 90 milliliters per minute (mL/min)

•Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening

Additional Inclusion Criteria for Groups 2 and 3

•Have stable severe renal impairment, assessed by eGFR less than 30 mL/min at screening or with end-stage renal disease (ESRD) who have been on a stable hemodialysis (HD) schedule for at least 3 months prior to planned dosing

•Have acceptable blood pressure and pulse rate

•If participants have Type 2 Diabetes Mellitus (T2DM), they must have a HbA1c equal to or less than 10.0% at screening

Exclusion criteria

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

•Have a current, functioning organ transplant. Nonfunctional renal allografts may be considered

•Have significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational product; or interfering with the interpretation of data

Groups 2 and 3

•Are receiving continuous HD or peritoneal dialysis.

•Have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before eloralintide administration

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 From Zero to Infinity AUC(0-∞) of LY3841136

Time frame:Predose on Day 1 up to Day 71

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Drug Concentration (Cmax) of LY3841136

Time frame:Predose on Day 1 up to Day 71

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.