A Study of Tirzepatide in Participants With Impaired Liver Function

Part of paid clinical trials in Tustin, California.

Sponsor
Eli Lilly and Company
Study ID
NCT03940742
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants. The study will last about two months and will include five visits to the study center.

Key Dates

Start date
Jul 22, 2019
Status verified
Jun 2022
Primary completion
Sep 22, 2020
Completion
Sep 22, 2020

Study Design

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

Arms

  • Active Comparator: Normal Hepatic Function
    Participants with normal hepatic function received single subcutaneous dose of 5 milligrams (mg) tirzepatide.
  • Experimental: Mild Hepatic Impairment
    Participants with mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.
  • Experimental: Moderate Hepatic Impairment
    Participants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.
  • Experimental: Severe Hepatic Impairment
    Participants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.

Primary Outcome Measure

Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide [ Time Frame: Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose ]

Locations (3)

FacilityCityStateZIPSite coordinators
Orange County Research CenterTustinCalifornia92780-
Orlando Clinical Research CenterOrlandoFlorida32809-
New Orleans Center for Clinical ResearchNew OrleansLouisiana70112-

Find similar trials in Tustin, CA

By research site
Orange County Research Center· Tustin, CAOrlando Clinical Research Center· Orlando, FLNew Orleans Center for Clinical Research· New Orleans, LA

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