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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
ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing
Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 85 days postdose
Awards & highlights

Study Summary

This trial looks at the effects of a drug called LY3819469 on people with and without kidney problems. It'll assess safety, levels in the bloodstream, and how long it takes to get rid of. Trial length up to 17 weeks.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been receiving hemodialysis treatment regularly for at least 3 months before the study starts.
Select...
Your body mass index is between 19.0 and 42.0 kilograms per square meter.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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
~100

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,603 Previous Clinical Trials
3,199,602 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,336 Previous Clinical Trials
403,777 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this research project still open?

"Based on the clinicaltrials.gov data, this medical trial is no longer enrolling patients. It was initially posted on April 25th 2023 and its last update came a day prior to that date. Nevertheless, there are 954 other trials currently accepting participants at the moment."

Answered by AI

Is this trial open to participants under the age of 25?

"This trial's eligibility criteria require that all participants are between 18 to 85 years old. For those below and above this range, there are 62 trials for minors and 510 studies specifically targeting seniors."

Answered by AI

Has FDA clearance been granted for LY3819469 (Control)?

"Our safety rating for the control drug LY3819469 is 1 due to its Phase 1 status, which means there are limited data affirming both its efficacy and security."

Answered by AI

Who meets the qualifications for enrollment in this experiment?

"This medical trial is open to patients aged 18-85 with kidney failure. Currently, 28 individuals are being sought after for enrollment."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Floridian Clinical Research
Omega Research Consultants
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~15 spots leftby Mar 2025