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

Part of paid clinical trials in Tustin, California.

Sponsor
Eli Lilly and Company
Study ID
NCT03482024
Phase
PHASE1
Status
Completed

Conditions

  • End Stage Renal Disease
  • Renal Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 30, 2018
Status verified
Jun 2022
Primary completion
Aug 19, 2019
Completion
Aug 19, 2019

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • 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 Outcome Measure

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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Orange County Research CenterTustinCalifornia92780-
Clinical Pharmacology of MiamiMiamiFlorida33014-
Orlando Clinical Research CenterOrlandoFlorida32809-
High Point Clinical Trials CenterHigh PointNorth Carolina27265-

Find similar trials in Tustin, CA

By research site
Orange County Research Center· Tustin, CAClinical Pharmacology of Miami· Miami, FLOrlando Clinical Research Center· Orlando, FLHigh Point Clinical Trials Center· High Point, NC

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