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

End Stage Renal Disease Clinical Trial

Official title:

Pharmacokinetics of Tirzepatide Following Administration to Subjects With Impaired Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482024
• Other study ID #: 17021
• Secondary ID: I8F-MC-GPGG
• Status: Completed
• Phase: Phase 1
• Start date: March 30, 2018
• Est. completion date: August 19, 2019

Study information

• Verified date: June 1, 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Tirzepatide
Administered SC.

Locations

Country	Name	City	State
United States	High Point Clinical Trials Center	High Point	North Carolina
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

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