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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEli Lilly and Company

About this trial

The purpose of the study is to assess the amount of Eloralintide (LY3841136) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants. The study drug will be administered subcutaneously (SC) (under the skin).

For each participant, the study will last about 14 weeks, excluding screening.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Are receiving continuous HD or peritoneal dialysis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY3841136

    Drug

    Administered SC

Treatment groups

28 Participants
are divided into 3 treatment groups
Group A: Eloralintide (Group 1)Experimental treatment 1 intervention
Group B: Eloralintide (Groups 2 and 3)Experimental treatment 1 intervention
Group C: Eloralintide (Group 3)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

PK: Maximum Observed Drug Concentration (Cmax) of LY3841136

Time frame
Predose on Day 1 up to Day 71

Secondary outcomes

Other outcomes

Sponsors and contacts

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