A Study of Tirzepatide in Participants With Impaired Liver Function

Phase 1

Completed

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Moderate Hepatic Impairment	Tirzepatide	Participants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.
Severe Hepatic Impairment	Tirzepatide	Participants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.
Normal Hepatic Function	Tirzepatide	Participants with normal hepatic function received single subcutaneous dose of 5 milligrams (mg) tirzepatide.
Mild Hepatic Impairment	Tirzepatide	Participants with mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

Locations (3): Orange County Research Center
🇺🇸
Tustin, California, United States
New Orleans Center for Clinical Research
🇺🇸
New Orleans, Louisiana, United States
Orlando Clinical Research Center
🇺🇸
Orlando, Florida, United States