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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 85
Updated:3/21/2019
Start Date:March 30, 2018
End Date:May 8, 2019
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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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.


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
We found this trial at
4
sites
Tustin, California
Principal Investigator: Joel M Neutel
Phone: 714-550-9990
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
Principal Investigator: Thomas C Marbury
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High Point, North Carolina 27265
Principal Investigator: Melanie Fein
Phone: 855-687-4257
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Miami, Florida 33014
Principal Investigator: Kenneth C Lasseter
Phone: 305-817-2900
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Miami, FL
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