A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function

June 9, 2022 updated by: Eli Lilly and Company

Pharmacokinetics of Tirzepatide Following Administration to Subjects With Impaired Renal Function

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 kidney function compared to healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Florida
      • Miami, Florida, United States, 33014
        • Clinical Pharmacology of Miami
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center
    • North Carolina
      • High Point, North Carolina, United States, 27265
        • High Point Clinical Trials Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All Participants:

    • 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 renal function, assessed by estimated glomerular filtration rate (eGFR) ≥90 milliliters per minute (mL/min) at screening

  • Participants with Renal Impairment or ESRD:

    -- Males or females with stable mild to severe renal impairment, assessed by eGFR or with ESRD (having received hemodialysis for at least 3 months)

  • Participants with Type 2 Diabetes Mellitus (T2DM) and Renal Impairment or ESRD:

    • Have T2DM controlled with diet or exercise alone or stable on metformin for at least 8 weeks
    • Taking stable doses of over-the-counter or prescription medications (eg, antihypertensive agents, aspirin, lipid-lowering agents) for treatment of concurrent medical conditions are permitted to participate providing they have been stable on their treatment regimen for at least 4 weeks
    • Have a hemoglobin A1c (HbA1c) ≥7.0% and ≤11.0% at screening

Exclusion Criteria:

  • All Participants:

    • Women of childbearing potential
    • 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 serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× the upper limit of normal (ULN) or total bilirubin (TBL) >1.5× ULN
    • 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 Renal Impairment or ESRD:

    • Have hemoglobin <8.5 grams per deciliter (g/dL) or significant active hematological disease from causes other than underlying renal disease.
    • Have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before LY3298176 administration

  • Participants with T2DM and Renal Impairment or ESRD:

    • Have taken any glucose-lowering medications other than metformin, including insulin, in the past 3 months before screening
    • Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide - Control
Group 1 - Tirzepatide 5 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function.
Drug: Tirzepatide
Administered SC.
Other Names:
  • LY3298176
Experimental: Tirzepatide - Mild Renal Impairment
Group 2 - Tirzepatide 5mg administered SC to participants with mild renal impairment.
Drug: Tirzepatide
Administered SC.
Other Names:
  • LY3298176
Experimental: Tirzepatide - Moderate Renal Impairment
Group 3 - Tirzepatide 5mg administered SC to participants with moderate renal impairment.
Drug: Tirzepatide
Administered SC.
Other Names:
  • LY3298176
Experimental: Tirzepatide - Severe Renal Impairment
Group 4 - Tirzepatide 5mg administered SC to participants with severe renal impairment.
Drug: Tirzepatide
Administered SC.
Other Names:
  • LY3298176
Experimental: Tirzepatide - End Stage Renal Disease (ESRD)
Group 5 - Tirzepatide 5mg administered SC to participants with ESRD.
Drug: Tirzepatide
Administered SC.
Other Names:
  • LY3298176

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Tlast (AUC[0-tlast])
Time Frame: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC[0-tlast]) of Tirzepatide was evaluated.
Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
PK: Maximum Concentration of Tirzepatide
Time Frame: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
Cmax is the maximum observed concentration of Tirzepatide.
Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC[0-inf])
Time Frame: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Tirzepatide was evaluated.
Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2018

Primary Completion (Actual)

August 19, 2019

Study Completion (Actual)

August 19, 2019

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

March 23, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17021
  • I8F-MC-GPGG (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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