A Study of Tirzepatide in Participants With Impaired Liver Function

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03940742
Collaborator
(none)
32
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Single Dose Pharmacokinetic Study of Tirzepatide in Subjects With Varying Degrees of Hepatic Impairment
Actual Study Start Date :
Jul 22, 2019
Actual Primary Completion Date :
Sep 22, 2020
Actual Study Completion Date :
Sep 22, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide Control

Tirzepatide administered subcutaneously (SC) to participants with normal hepatic function

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
  • Experimental: Tirzepatide Mild

    Tirzepatide administered SC to participants with mild hepatic impairment

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176
  • Experimental: Tirzepatide Moderate

    Tirzepatide administered SC to participants with moderate hepatic impairment

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176
  • Experimental: Tirzepatide Severe

    Tirzepatide administered SC to participants with severe hepatic impairment

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176
  • Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide [Predose through 336 hours postdose]

      PK: AUC(0-∞) of Tirzepatide

    2. PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide [Predose through 336 hours postdose]

      PK: Cmax of Tirzepatide

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    All Participants:
    • Women of childbearing potential are excluded from the study.

    • Women not of childbearing potential may participate and include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or postmenopausal

    • Are between the body mass index (BMI) of 19.0 and 40.0 kilograms per meter squared (kg/m²), inclusive, at screening

    Healthy Participants:
    • Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function
    Participants with Impaired Liver Function:
    • Males or females with chronic mild, moderate and severe liver impairment, assessed by Child-Pugh scoring

    • Have type 2 diabetes mellitus (T2DM) controlled with diet or exercise alone or on stable doses of metformin for at least 8 weeks

    • Have a hemoglobin A1c (HbA1c) ≥6.0% and ≤11.0% at screening

    Exclusion Criteria:
    All Participants:
    • Have known allergies to tirzepatide or related compounds

    • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2

    • Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors

    Participants with Impaired Liver Function:
    • Have hemoglobin <8.5 grams per deciliter (g/dL)

    • Have kidney function that is significantly impaired at screening

    • Have taken any glucose-lowering medications other than metformin, including insulin, in the past 3 months before screening

    • Have brain function impaired significantly due to liver condition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Orange County Research Center Tustin California United States 92780
    2 Orlando Clinical Research Center Orlando Florida United States 32809
    3 New Orleans Center for Clinical Research New Orleans Louisiana United States 70112

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03940742
    Other Study ID Numbers:
    • 17102
    • I8F-MC-GPGQ
    First Posted:
    May 7, 2019
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2020