A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function

Part of paid clinical trials in Tustin, California.

Sponsor
Eli Lilly and Company
Study ID
NCT05611957
Phase
PHASE1
Status
Completed

Conditions

  • Healthy
  • Renal Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • LY3437943 — DRUG
    Administered SC.

Study Details

The main purpose of this study is to assess the amount of study drug 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 healthy participants. The study will last up to 5 weeks, excluding screening.

Key Dates

Start date
Nov 16, 2022
Status verified
Sep 2023
Primary completion
Sep 5, 2023
Completion
Sep 5, 2023

Study Design

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

Arms

  • Experimental: LY3437943 (Control)
    LY3437943 administered subcutaneous (SC) to participants with normal renal function
  • Experimental: LY3437943 (Severe Renal Impairment)
    LY3437943 administered SC to participants with severe renal impairment
  • Experimental: LY3437943 (End-Stage Renal Disease)
    LY3437943 administered SC to participants with end-stage renal disease

Primary Outcome Measure

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943 [ Time Frame: Predose up to 31 days postdose ]

Locations (4)

FacilityCityStateZIPSite coordinators
Orange County Research CenterTustinCalifornia92780-
Clinical Pharmacology of MiamiMiamiFlorida33014-3616-
Orlando Clinical Research CenterOrlandoFlorida32809-
Nucleus NetworksSaint PaulMinnesota55114-

Find similar trials in Tustin, CA

By research site
Orange County Research Center· Tustin, CAClinical Pharmacology of Miami· Miami, FLOrlando Clinical Research Center· Orlando, FLNucleus Networks· Saint Paul, MN

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