A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants

What Was Tested

In this phase 1 trial, researchers set out to test Orforglipron (Foundayo, non-peptide).

The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants.

The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated.

The study may last up to approximately 77 days for each participant.

It had 1 arm (groups): Orforglipron + Carbamazepine (experimental).

The registry classes the interventions as drug.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 21 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Participants must be overtly healthy individuals, assigned male at birth (AMAB) or individuals not of childbearing potential (INOCBP). Have a body weight equal to or greater than 45 kg, and body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening. Have a hemoglobin level of. Have venous access sufficient to allow for blood sampling.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: have an abnormal 12-lead electrocardiogram (ecg); have a history or presence of multiple or severe allergies, or severe post treatment hypersensitivity reactions; have known allergies to carbamazepine or to orforglipron, related compounds, or any components of the formulation.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Orforglipron (Foundayo, non-peptide) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-05-06 with completion listed for 2024-07-23.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron. PK: Maximum Observed Concentration (Cmax) of Orforglipron.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Orforglipron (Foundayo, non-peptide) in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Orforglipron (Foundayo, non-peptide) compound page, all human trials.