Study S000520

A Phase 1, Multicenter, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05882032
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 29
Start: 2023-06-13
Primary completion: 2024-11-18
Lead sponsor: Eli Lilly and Company
Conditions: Healthy; Hepatic Insufficiency
Interventions: DRUG:LY3502970
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:J2A-MC-GZPB

Registered primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970 [Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1]
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970 [Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1]
PK: Maximum Observed Concentration (Cmax) of LY3502970 [Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1]

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