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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT03482024 (opens ClinicalTrials.gov in a new tab)Other id17021Other idI8F-MC-GPGG

Overview

Status
Completed
Phase
Phase 1
Enrollment
45 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
30 Mar 2018
Primary completion
19 Aug 2019
Completion
19 Aug 2019
First posted
29 Mar 2018
Last update posted
23 Mar 2023
Conditions
Renal Insufficiency · End Stage Renal Disease

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 1

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

    NCT03482024

    30 Mar 2018 to 19 Aug 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug

Arms5

  • Experimental

    Tirzepatide - Control

    Group 1 - Tirzepatide 5 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function.

  • Experimental

    Tirzepatide - Mild Renal Impairment

    Group 2 - Tirzepatide 5mg administered SC to participants with mild renal impairment.

  • Experimental

    Tirzepatide - Moderate Renal Impairment

    Group 3 - Tirzepatide 5mg administered SC to participants with moderate renal impairment.

  • Experimental

    Tirzepatide - Severe Renal Impairment

    Group 4 - Tirzepatide 5mg administered SC to participants with severe renal impairment.

  • Experimental

    Tirzepatide - End Stage Renal Disease (ESRD)

    Group 5 - Tirzepatide 5mg administered SC to participants with ESRD.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC\[0-tlast\]) of Tirzepatide was evaluated.

  2. PK: Maximum Concentration of Tirzepatide

    Time frame · Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

    Registry description

    Cmax is the maximum observed concentration of Tirzepatide.

  3. 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

    Registry description

    Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-inf\]) of Tirzepatide was evaluated.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeGeometric mean· Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Tlast (AUC[0-tlast])

GroupValue (Nanogram*hour per Millilitre (ng*h/mL))Spread
Tirzepatide - Control7840024
Tirzepatide - Mild Renal Impairment8190036
Tirzepatide - Moderate Renal Impairment9830032
Tirzepatide - Severe Renal Impairment812009
Tirzepatide - End Stage Renal Disease (ESRD)8850014
Primary outcomeGeometric mean· Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

PK: Maximum Concentration of Tirzepatide

GroupValue (Nanogram per Millilitre (ng/mL))Spread
Tirzepatide - Control33921
Tirzepatide - Mild Renal Impairment35342
Tirzepatide - Moderate Renal Impairment36936
Tirzepatide - Severe Renal Impairment41711
Tirzepatide - End Stage Renal Disease (ESRD)34730
Primary outcomeGeometric mean· 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])

GroupValue (Nanogram*hour per Millilitre (ng*h/mL))Spread
Tirzepatide - Control8050025
Tirzepatide - Mild Renal Impairment8420037
Tirzepatide - Moderate Renal Impairment1040032
Tirzepatide - Severe Renal Impairment8300010
Tirzepatide - End Stage Renal Disease (ESRD)9340012

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Tirzepatide - ControlParticipants received single dose of 5 5mg Tirzepatide by subcutaneous injection.0 / 140 / 141 / 14
Tirzepatide - Mild Renal ImpairmentParticipants received single dose of 5mg Tirzepatide by subcutaneous injection.0 / 80 / 84 / 8
Tirzepatide - Moderate Renal ImpairmentParticipants received single dose of 5mg Tirzepatide by subcutaneous injection.0 / 80 / 83 / 8
Tirzepatide - Severe Renal ImpairmentParticipants received single dose of 5mg Tirzepatide by subcutaneous injection.0 / 70 / 73 / 7
Tirzepatide - End Stage Renal Disease (ESRD)Participants received single dose of 5mg Tirzepatide by subcutaneous injection.0 / 80 / 83 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2021

5 results

Effects of Renal Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide.

Urva et al. 2021Clinical pharmacokineticscited by 46

PMID 33778934PMC8332596DOI 10.1007/s40262-021-01012-2PUB-33778934

Free to read · publisher termsCC BY-NC5 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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