Results from a PHASE1 drug-drug interaction (DDI) study investigating Orforglipron with Carbamazepine in healthy participants were posted on 2026-07-17. The study reported pharmacokinetic data, including a geometric mean Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of 104 ng*h/mL for Orforglipron when co-administered with Carbamazepine. This trial enrolled 30 participants to assess the effect of Carbamazepine on Orforglipron exposure.

Background

Orforglipron was investigated in a drug-drug interaction study to understand its pharmacokinetic profile when co-administered with Carbamazepine. The study focused on healthy participants to characterize potential interactions.

Trial design

The study, identified as NCT06370728, was a PHASE1 drug-drug interaction trial that enrolled 30 healthy participants. The main purpose was to assess the effect of Carbamazepine on the amount of Orforglipron in the bloodstream and its elimination time when given orally. The safety and tolerability of Orforglipron and Carbamazepine, given separately or together, were also evaluated. Participants were administered Orforglipron and Carbamazepine.

Key results

Pharmacokinetic results for Orforglipron when co-administered with Carbamazepine in healthy participants were reported. Key measurements included:

  • Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron showed geometric mean values of 104 ng*h/mL (Geometric Coefficient of Variation 26.6) and 18.5 ng*h/mL (Geometric Coefficient of Variation 41.7).
  • Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC [0-tlast]) of Orforglipron showed geometric mean values of 93.4 ng*h/mL (Geometric Coefficient of Variation 24.6) and 15.8 ng*h/mL (Geometric Coefficient of Variation 51.8).
  • Maximum Observed Concentration (Cmax) of Orforglipron showed geometric mean values of 4.97 ng/mL (Geometric Coefficient of Variation 31.0) and 2.22 ng/mL (Geometric Coefficient of Variation 47.3).

What this means

The pharmacokinetic data from this PHASE1 study provides specific exposure metrics for Orforglipron when co-administered with Carbamazepine in healthy individuals. These geometric mean values for AUC and Cmax, along with their coefficients of variation, contribute to the understanding of Orforglipron's profile in the presence of Carbamazepine. Such data is crucial for informing potential dosing adjustments or contraindications when Orforglipron is used clinically with drugs that may interact with its metabolism.

Source

This information was sourced from ClinicalTrials.gov, documenting the results of trial NCT06370728, which were posted on 2026-07-17. The study details are available on clinicaltrials.gov.