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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03940742
Other study ID # 17102
Secondary ID I8F-MC-GPGQ
Status Completed
Phase Phase 1
First received
Last updated
Start date July 22, 2019
Est. completion date September 22, 2020

Study information

Verified date June 1, 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date September 22, 2020
Est. primary completion date September 22, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tirzepatide
Administered SC

Locations

Country Name City State
United States New Orleans Center for Clinical Research New Orleans Louisiana
United States Orlando Clinical Research Center Orlando Florida
United States Orange County Research Center Tustin California

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-8]) of Tirzepatide Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-8]) of Tirzepatide. Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose
Primary PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide. Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose
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