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Monoclonal Antibodies

LY3819469 for Renal Function

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 85 days postdose
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, the study aims to evaluate the general safety and tolerability of LY3819469 in participants which typically includes monitoring for any adverse reactions that may arise during the course.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 85 days postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 85 days postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469
PK: Maximum observed concentration (Cmax) of LY3819469
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: LY3819469 (Severe Renal Impairment)Experimental Treatment1 Intervention
LY3819469 administered SC to participants with severe renal impairment
Group II: LY3819469 (End-Stage Renal Disease)Experimental Treatment1 Intervention
LY3819469 administered SC to participants with end-stage renal disease (ESRD)
Group III: LY3819469 (Control)Experimental Treatment1 Intervention
LY3819469 administered subcutaneously (SC) to participants with normal renal function
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3819469
2023
Completed Phase 1
~120

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for kidney failure, such as ACE inhibitors, ARBs, and immunosuppressants, work by reducing proteinuria and controlling blood pressure to slow the progression of kidney damage. The study of pharmacokinetics, like in the trial of LY3819469, is essential for understanding how these drugs are processed in patients with impaired renal function. This knowledge helps in adjusting dosages to ensure the medications are effective while minimizing the risk of toxicity, which is particularly important for maintaining the health and safety of kidney failure patients.
Optimal Mode of clearance in critically ill patients with Acute Kidney Injury (OMAKI)--a pilot randomized controlled trial of hemofiltration versus hemodialysis: a Canadian Critical Care Trials Group project.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,657 Previous Clinical Trials
3,224,864 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,380 Previous Clinical Trials
423,718 Total Patients Enrolled

Media Library

LY3819469 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05841277 — Phase 1
Kidney Failure Research Study Groups: LY3819469 (Control), LY3819469 (Severe Renal Impairment), LY3819469 (End-Stage Renal Disease)
Kidney Failure Clinical Trial 2023: LY3819469 Highlights & Side Effects. Trial Name: NCT05841277 — Phase 1
LY3819469 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05841277 — Phase 1
~10 spots leftby Oct 2025