A Study of Tirzepatide in Participants With Impaired Liver Function

Hepatic Insufficiency Clinical Trial

Official title:

A Single Dose Pharmacokinetic Study of Tirzepatide in Subjects With Varying Degrees of Hepatic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940742
• Other study ID #: 17102
• Secondary ID: I8F-MC-GPGQ
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

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

External Links

•   A Study of Tirzepatide in Participants With Impaired Liver Function