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New treatment option for Kidney Disease
Official title A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function
ClinicalTrials.gov ID: NCT07426380
What this study is testing
What is LY3841136?
LY3841136 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for kidney disease.
Also referred to as Eloralintide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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)...
- Have no significant history of spontaneous or ethanol-induced hypoglycemia Additional for Group 1
- Are healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated...
- Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening Additional 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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 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...
- Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening Additional 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami Lakes, Florida, United States; Orlando, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.