A Study of Tirzepatide in Participants With Impaired Liver Function

• Status: Completed
• Trial end date: 2020-09-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Tirzepatide

Criteria

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