A Study of LY3473329 in Participants With Impaired and Normal Renal Function

NCT05778864 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18638J2O-MC-EKBE
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 4

Brief Summary

The main purpose of this study is to assess the amount of study drug (LY3473329) 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 LY3473329 will also be evaluated in these participants. The study will last up to 8 weeks including screening period.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329

  PK: AUC0-∞ of LY3473329

  Predose up to 34 days postdose

• PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329

  PK: AUC0-tlast of LY3473329

  Predose up to 34 days postdose

• PK: Maximum observed concentration (Cmax) of LY3473329

  PK: Cmax of LY3473329

  Predose up to 34 days postdose

Study Arms (5)

LY3473329 (Control)

EXPERIMENTAL

LY3473329 administered orally to participants with normal renal function

Drug: LY3473329

LY3473329 (Mild Renal Impairment)

EXPERIMENTAL

LY3473329 administered orally to participants with mild renal impairment

Drug: LY3473329

LY3473329 (Moderate Renal Impairment)

EXPERIMENTAL

LY3473329 administered orally to participants with moderate renal impairment

Drug: LY3473329

LY3473329 (Severe Renal Impairment)

EXPERIMENTAL

LY3473329 administered orally to participants with severe renal impairment

Drug: LY3473329

LY3473329 (End-Stage Renal Disease)

EXPERIMENTAL

LY3473329 administered orally to participants with end-stage renal disease

Drug: LY3473329

Interventions

LY3473329 DRUG

Administered orally.

LY3473329 (Control); LY3473329 (End-Stage Renal Disease); LY3473329 (Mild Renal Impairment); LY3473329 (Moderate Renal Impairment); LY3473329 (Severe Renal Impairment)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, women of childbearing potential (WOCP) who agree to use highly effective or effective methods of contraception, and women not of childbearing potential (WNOCBP) may participate in this trial
• Have clinical laboratory test results within the normal reference range for the population

You may not qualify if:

• Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study
• Have any abnormality in the 12-lead electrocardiogram (ECG), blood pressure and/or pulse rate that, in the opinion of the investigator, increases the risks associated with participating in the study
• Hemoglobin less than 8 grams/deciliter (g/dL) and/or clinically significant anemia symptoms
• Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age
• Smoke more than 10 cigarettes per day or the equivalent
• Have donated blood of more than 500 milliliter (mL) within 3 months prior to screening

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, 32132, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33417, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 21, 2023
• Study Start: March 17, 2023
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)