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A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482024
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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 kidney function compared to healthy participants.

Condition or disease Intervention/treatment Phase
Renal Insufficiency End Stage Renal Disease Drug: Tirzepatide Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of Tirzepatide Following Administration to Subjects With Impaired Renal Function
Actual Study Start Date : March 30, 2018
Actual Primary Completion Date : August 19, 2019
Actual Study Completion Date : August 19, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Tirzepatide - Healthy
Group 1 - Tirzepatide administered subcutaneously (SC) to healthy participants with normal renal function.
 Drug: Tirzepatide
Administered SC.
Other Name: LY3298176
Experimental: Tirzepatide - Mild Renal Impairment
Group 2 - Tirzepatide administered SC to participants with mild renal impairment.
 Drug: Tirzepatide
Administered SC.
Other Name: LY3298176
Experimental: Tirzepatide - Moderate Renal Impairment
Group 3 - Tirzepatide administered SC to participants with moderate renal impairment.
 Drug: Tirzepatide
Administered SC.
Other Name: LY3298176
Experimental: Tirzepatide - Severe Renal Impairment
Group 4 - Tirzepatide administered SC to participants with severe renal impairment.
 Drug: Tirzepatide
Administered SC.
Other Name: LY3298176
Experimental: Tirzepatide - End Stage Renal Disease (ESRD)
Group 5 - Tirzepatide administered SC to participants with ESRD.
 Drug: Tirzepatide
Administered SC.
Other Name: LY3298176


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide [ Time Frame: Predose through 336 hours postdose ]
    PK: AUC of tirzepatide

  2. PK: Maximum Concentration of Tirzepatide [ Time Frame: Predose through 336 hours postdose ]
    PK: Cmax of tirzepatide


Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT03482024


Locations
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United States, California
Orange County Research Center
Tustin, California, United States, 92780
United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, North Carolina
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03482024    
Other Study ID Numbers: 17021
I8F-MC-GPGG ( Other Identifier: Eli Lilly and Company )
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 1, 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Tirzepatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists