A Study of Tirzepatide in Participants With Impaired Liver Function

NCT03940742 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17102I8F-MC-GPGQ
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatic Insufficiency

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide

  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

• 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

Study Arms (4)

Normal Hepatic Function

ACTIVE COMPARATOR

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

Drug: Tirzepatide

Mild Hepatic Impairment

EXPERIMENTAL

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

Drug: Tirzepatide

Moderate Hepatic Impairment

EXPERIMENTAL

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

Drug: Tirzepatide

Severe Hepatic Impairment

EXPERIMENTAL

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

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

Mild Hepatic Impairment; Moderate Hepatic Impairment; Normal Hepatic Function; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Orange County Research Center

Tustin, California, 92780, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

New Orleans Center for Clinical Research

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

• Urva S, Quinlan T, Landry J, Ma X, Martin JA, Benson CT. Effects of Hepatic Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide. Clin Pharmacokinet. 2022 Jul;61(7):1057-1067. doi: 10.1007/s40262-022-01140-3. Epub 2022 Jun 8.

  PMID: 35674880 DERIVED

Related Links

• A Study of Tirzepatide in Participants With Impaired Liver Function

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 7, 2019
• Study Start: July 22, 2019
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: March 24, 2023
• Results First Posted: March 24, 2023

Record last verified: 2022-06-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)