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A Study of Tirzepatide in Participants With Impaired Liver Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940742
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Hepatic Insufficiency Drug: Tirzepatide Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single Dose Pharmacokinetic Study of Tirzepatide in Subjects With Varying Degrees of Hepatic Impairment
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : August 18, 2020
Estimated Study Completion Date : August 18, 2020

Arm Intervention/treatment
Experimental: Tirzepatide Control
Tirzepatide administered subcutaneously (SC) to participants with normal hepatic function
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: Tirzepatide Mild
Tirzepatide administered SC to participants with mild hepatic impairment
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: Tirzepatide Moderate
Tirzepatide administered SC to participants with moderate hepatic impairment
Drug: Tirzepatide
Administered SC
Other Name: LY3298176

Experimental: Tirzepatide Severe
Tirzepatide administered SC to participants with severe hepatic impairment
Drug: Tirzepatide
Administered SC
Other Name: LY3298176




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide [ Time Frame: Predose through 336 hours postdose ]
    PK: AUC(0-∞) of Tirzepatide

  2. PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide [ Time Frame: Predose through 336 hours postdose ]
    PK: Cmax of Tirzepatide



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940742


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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United States, California
Orange County Research Center Recruiting
Tustin, California, United States, 92780
Contact    714-550-9990      
Principal Investigator: Joel M Neutel         
United States, Florida
Orlando Clinical Research Center Recruiting
Orlando, Florida, United States, 32809
Contact    407-240-7878      
Principal Investigator: Thomas C Marbury         
United States, Louisiana
New Orleans Center for Clinical Research Recruiting
New Orleans, Louisiana, United States, 70112
Contact    865-305-9100 ext 7      
Principal Investigator: William B. Smith         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03940742    
Other Study ID Numbers: 17102
I8F-MC-GPGQ ( Other Identifier: Eli Lilly and Company )
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases