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

Part of paid clinical trials in Miami, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT05936138
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Renal Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • LY3502970 — DRUG
    Administered orally.

Study Details

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.

Key Dates

Start date
Jul 13, 2023
Status verified
Jun 2026
Primary completion
Apr 11, 2024
Completion
Apr 11, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3502970 (Normal Renal Function)
    A single oral dose of 1 milligram (mg) LY3502970 was administered to participants with normal renal function \[defined as an estimated glomerular filtration rate (eGFR: ≥ 90 milliliters per minute (mL/min), and without a diagnosis of type 2 diabetes mellitus (T2D)\] on day 1.
  • Experimental: LY3502970 (Severe Renal Impairment)
    A single oral dose of 1 mg LY3502970 was administered to participants with severe renal function \[defined as an eGFR: 15-29 mL/min and not requiring hemodialysis, with a diagnosis of T2D\] on day 1.
  • Experimental: LY3502970 (End-Stage Renal Disease)
    A single oral dose of 1 mg LY3502970 was administered to participants with end stage renal disease \[defined as an eGFR: less than 15 mL/min or requiring hemodialysis, with a diagnosis of T2D\] on day 1.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY3502970 [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours postdose ]

Locations (4)

FacilityCityStateZIPSite coordinators
Advanced Pharma CR, LLCMiamiFlorida33147-
Clinical Pharmacology of MiamiMiamiFlorida33014-
Orlando Clinical Research CenterOrlandoFlorida32809-
Alliance For multispecialty Research, LLCKnoxvilleTennessee37920-

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By research site
Advanced Pharma CR, LLC· Miami, FLClinical Pharmacology of Miami· Miami, FLOrlando Clinical Research Center· Orlando, FLAlliance For multispecialty Research, LLC· Knoxville, TN

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