A Study of Tirzepatide in Participants With Impaired Liver Function

Lilly

Status and phase: Completed; Phase 1

Conditions: Hepatic Insufficiency

Treatments: Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03940742

I8F-MC-GPGQ (Other Identifier)

17102

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

Normal Hepatic Function

Active Comparator group

Description:

Participants with normal hepatic function received single subcutaneous dose of 5 milligrams (mg) tirzepatide.

Treatment:

Drug: Tirzepatide

Mild Hepatic Impairment

Experimental group

Description:

Participants with mild hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.

Treatment:

Drug: Tirzepatide

Moderate Hepatic Impairment

Experimental group

Description:

Participants with moderate hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.

Treatment:

Drug: Tirzepatide

Severe Hepatic Impairment

Experimental group

Description:

Participants with severe hepatic impairment received single subcutaneous dose of 5 mg tirzepatide.

Treatment:

Drug: Tirzepatide