LY3819469 for Renal Function

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

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new medication called LY3819469. It aims to see how much of the drug gets into the blood and how quickly it is removed in people with kidney problems compared to those without. The study will also check if the drug is safe and well-tolerated.

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.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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