A Study of Tirzepatide in Participants With Impaired Liver Function
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Intervention: Tirzepatide
Intervention description: Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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