Study S000610

A Single Dose Pharmacokinetic Study of Tirzepatide in Subjects With Varying Degrees of Hepatic Impairment

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03940742
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 32
Start: 2019-07-22
Primary completion: 2020-09-22
Lead sponsor: Eli Lilly and Company
Conditions: Hepatic Insufficiency
Interventions: DRUG:Tirzepatide
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:I8F-MC-GPGQ

Registered primary outcomes

Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide [Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose]
PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide [Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0010820	Effects of Hepatic Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide. Urva S, Clinical pharmacokinetics	2022	Other trial	PMID 35674880 DOI	cites ClinicalTrials.gov:NCT03940742; registry reference DERIVED:35674880