Clinical trial NCT05841277: A Study of LY3819469 in Participants With Impaired and Normal Renal Function
Official title: Pharmacokinetics of LY3819469 Following Subcutaneous Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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 it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3819469 will also be evaluated in these participants. The study will last up to 17 weeks including screening period.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)
* Men who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial

Participants with Normal Renal Function:

* Have estimated glomerular filtration rate (eGFR) determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) greater than or equal to 90 milliliter per minute (mL/min)

Participants with Renal Impairment:

* Severe renal impairment: Have eGFR determined by CKD-EPI of less than 30 mL/min and not requiring dialysis
* ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing

Exclusion Criteria:

* Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition
* Have any abnormality in the 12-lead electrocardiogram (ECG)
* Hemoglobin less than 8 grams per deciliter (g/dL) and clinically significant anemia symptoms
* Have known allergies to LY3819469, related compounds or any components of the formulation, or a history of significant atopy
* Have participated in any Lp(a) siRNA therapeutic clinical trial within the last 1 year

Primary outcomes:
measure: Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469
timeFrame: Predose up to 85 days postdose
measure: PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469
timeFrame: Predose up to 85 days postdose
measure: PK: Maximum observed concentration (Cmax) of LY3819469
timeFrame: Predose up to 85 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Floridian Clinical Research
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants
state: Florida
city: Saint Paul
country: United States
facility: Nucleus Networks
state: Minnesota
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: