A Study of LY3502970 in Participants With Normal and Impaired Renal Function

A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment

The main purpose of this study is to assess the amount of study drug (LY3502970) 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 LY3502970 will also be evaluated in these participants. The study will last up to 6 weeks including screening period.

Study Overview

• Status: Completed
• Conditions: Healthy; Renal Insufficiency
• Intervention / Treatment: Drug: LY3502970

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: ClinicalTrials.gov@lilly.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33147
      • Advanced Pharma CR, LLC
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
      • Principal Investigator: Alexander Prezioso
      • Contact: Phone Number: 305-817-2900
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
      • Principal Investigator: Thomas C Marbury
      • Contact: Phone Number: 407-475-0227
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research, LLC
      • Principal Investigator: William B. Smith
      • Contact: Phone Number: +1 865-305-9100 x2246

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive.
• Men and women who agree to use highly effective or effective methods of contraception may participate in this trial.

Participants with Normal Renal Function:

• Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min)

Participants with Renal Impairment:

• Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis.
• ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing.

Exclusion Criteria:

• Have a current, functioning organ transplant. Non-functional renal allografts may be allowed.
• Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications.
• Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy.
• Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study.
• Have a history or presence of chronic or acute pancreatitis

Participants with Renal Impairment:

• Have hemoglobin <8.5 g/dL.
• Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3502970 (Severe Renal Impairment); LY3502970 administered orally to participants with severe renal impairment	Drug: LY3502970; Administered orally.
Experimental: LY3502970 (End-Stage Renal Disease); LY3502970 administered orally to participants with end-stage renal disease (ESRD)	Drug: LY3502970; Administered orally.
Experimental: LY3502970 (Control); LY3502970 administered orally to participants with normal renal function	Drug: LY3502970; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970	PK: (AUC0-∞) of LY3502970	Predose up to 12 days postdose
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970	PK: AUC0-tlast of LY3502970	Predose up to 12 days postdose
PK: Maximum observed concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 12 days postdose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Actual): April 11, 2024
• Study Completion (Actual): April 11, 2024

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: 18633; J2A-MC-GZPC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No