Study S000127

Pharmacokinetics of Tirzepatide Following Administration to Subjects With Impaired Renal Function

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: NCT03482024
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 45
Start: 2018-03-30
Primary completion: 2019-08-19
Lead sponsor: Eli Lilly and Company
Conditions: Renal Insufficiency; End Stage Renal Disease
Interventions: DRUG:Tirzepatide
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:I8F-MC-GPGG

Registered primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Tlast (AUC[0-tlast]) [Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose]
PK: Maximum Concentration of Tirzepatide [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]) [Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose]

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
R0010743	Effects of Renal Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide. Urva S, Clinical pharmacokinetics	2021	Other trial	PMID 33778934 DOI	cites ClinicalTrials.gov:NCT03482024; registry reference DERIVED:33778934