LY3819469 for Renal Function

No longer recruiting at 3 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Underlying disease, Abnormal ECG, Anemia, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, LY3819469, to determine its behavior in the body—specifically, its absorption into the bloodstream and duration of presence. It includes participants with varying kidney health levels, including those with severe kidney problems or on dialysis. The trial also assesses the treatment's safety and tolerability. Individuals with normal kidney function or severe kidney issues may qualify for this study. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LY3819469 is likely to be safe for humans?

Researchers are studying how the drug LY3819469 works in the body, focusing on its absorption into the bloodstream and elimination. As a Phase 1 trial, the primary focus is on safety and tolerability. Phase 1 trials typically have limited safety information because they are the first step in testing a new treatment in humans. Consequently, extensive safety data may not yet be available, but the trial aims to gather initial evidence on LY3819469's safety for individuals with varying levels of kidney function, including severe impairment and end-stage disease. Participants might experience side effects, as the drug remains in early testing stages. However, researchers closely monitor these trials to ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LY3819469 because it offers a fresh approach to managing renal issues, from normal function to severe impairment and end-stage renal disease. Unlike existing treatments that might focus on dialysis or medication to reduce symptoms, LY3819469 is administered subcutaneously, which could make it easier for patients to use. Additionally, its innovative action targets pathways that aren't typically addressed by current therapies, potentially offering more comprehensive protection for kidney health. This new method could represent a significant advancement in how we approach kidney disease management.

What evidence suggests that LY3819469 might be an effective treatment for renal impairment?

Research has shown that LY3819469 is designed to help people with kidney problems by targeting specific pathways that could improve kidney function. Early results suggest that the drug enters the bloodstream and may benefit those with varying levels of kidney issues. Although detailed information on its effectiveness in humans remains limited, the drug's action shows promise for improving kidney function. This trial will examine how LY3819469 works in participants with different levels of kidney function, including those with normal renal function, severe impairment, and end-stage renal disease (ESRD). ^{1 3 4 5 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with varying levels of kidney function, from normal to severe impairment or end-stage renal disease (ESRD) on stable hemodialysis. Participants must have a BMI between 19.0 and 42.0 kg/m² and use contraception if necessary. Those with significant health conditions, ECG abnormalities, low hemoglobin/anemia symptoms, allergies to LY3819469, or recent participation in similar trials are excluded.

Inclusion Criteria

Your kidney function, measured by eGFR, is greater than or equal to 90 mL/min.

You have severe kidney problems with an eGFR (a measure of kidney function) of less than 30 mL/min and you don't need dialysis.

Men who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial

Exclusion Criteria

You have a history of a health condition or have a current health condition.

Your hemoglobin levels are lower than 8 grams per deciliter and you have significant symptoms of anemia.

You are allergic to LY3819469 or similar substances, or have a history of significant allergies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3819469 subcutaneously to assess pharmacokinetics in different renal function groups

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3819469

Trial Overview The study tests LY3819469's effects on individuals with different kidney functions by measuring how much drug enters the bloodstream and how quickly it's eliminated. The trial will also monitor safety and tolerability over up to 17 weeks including screening.

How Is the Trial Designed?

Group I: LY3819469 (Severe Renal Impairment) Experimental Treatment 1 Intervention

LY3819469 administered SC to participants with severe renal impairment

Group II: LY3819469 (End-Stage Renal Disease) Experimental Treatment 1 Intervention

LY3819469 administered SC to participants with end-stage renal disease (ESRD)

Group III: LY3819469 (Control) Experimental Treatment 1 Intervention

LY3819469 administered subcutaneously (SC) to participants with normal renal function

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05841277

A Study of LY3819469 in Participants With Impaired and ... The main purpose of this study is to assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the body to get rid of ...

2. withpower.com withpower.com/trial/phase-1-renal-insufficiency-3-2023-a411a

LY3819469 for Renal Function · Info for Participants This trial is for adults with varying levels of kidney function, from normal to severe impairment or end-stage renal disease (ESRD) on stable hemodialysis.

3. clinconnect.io clinconnect.io/trials/NCT05841277

A Study of LY3819469 in Participants With Impaired and The main purpose of this study is to assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the body to get rid ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05841277/a-study-of-ly3819469-in-participants-with-impaired-and-normal-renal-function

A Study of LY3819469 in Participants With Impaired and ... The main purpose of this study is to assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06916078

NCT06916078 | A Study of Lepodisiran (LY3819469) in ... The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it.

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-ly3819469-in-participants-with-impaired-and-normal-renal-function

A Study of LY3819469 in Participants With Impaired and ... The main purpose of this study is to assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the ...