Study S000645

A Drug-Drug Interaction Study to Assess the Effect of Carbamazepine on the Pharmacokinetics of Orforglipron in Healthy Participants

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: NCT06370728
Study type: INTERVENTIONAL
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 30
Start: 2024-05-06
Primary completion: 2024-07-23
Lead sponsor: Eli Lilly and Company
Conditions: Healthy
Interventions: DRUG:Orforglipron; DRUG:Carbamazepine
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: OTHER:J2A-MC-GZPJ

Registered primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Orforglipron [Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)]
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron [Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)]
PK: Maximum Observed Concentration (Cmax) of Orforglipron [Day 1 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose); Day 15 (Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, and 72 hours post-dose)]

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