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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of Tirzepatide in Participants With Impaired Liver Function

NCTNCT03940742 (opens ClinicalTrials.gov in a new tab)Other id17102Other idI8F-MC-GPGQ
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
32 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
22 Jul 2019
Primary completion
22 Sept 2020
Completion
22 Sept 2020
First posted
7 May 2019
Last update posted
24 Mar 2023
Conditions
Hepatic Insufficiency

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 1

    A Study of Tirzepatide in Participants With Impaired Liver Function

    NCT03940742

    22 Jul 2019 to 22 Sept 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug

Arms4

  • 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 outcomes2

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC\[0-∞\]) of Tirzepatide.

  2. PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

    Time frame · Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose

    Registry description

    PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose

Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide

GroupValue (nanogram*hour per milliliter (ng*h/mL))Spread
Control (Normal Hepatic Function)8430028
Mild Hepatic Impairment10200016
Moderate Hepatic Impairment8200029
Severe Hepatic Impairment7700033
Primary outcomeGeometric mean· Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose

PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

GroupValue (ng/mL)Spread
Control (Normal Hepatic Function)51028
Mild Hepatic Impairment50918
Moderate Hepatic Impairment51644
Severe Hepatic Impairment52123

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Control (Normal Hepatic Function)Participants with normal hepatic function received single subcutaneous dose of 5 mg tirzepatide.0 / 130 / 134 / 13
Mild Hepatic ImpairmentParticipants with mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.0 / 60 / 62 / 6
Moderate Hepatic ImpairmentParticipants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.0 / 60 / 62 / 6
Severe Hepatic ImpairmentParticipants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.0 / 71 / 72 / 7

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2022

Effects of Hepatic Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide.

Urva et al. 2022Clinical pharmacokineticscited by 28

PMID 35674880PMC9287213DOI 10.1007/s40262-022-01140-3PUB-35674880

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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