A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants

What Was Tested

This registered phase 1 trial tested Orforglipron (Foundayo, non-peptide).

The main purpose of this study is to determine effect of orforglipron capsule formulation on the amount of digoxin, rosuvastatin, acetaminophen, midazolam, and simvastatin (each given alone and together with orforglipron) that enters the bloodstream and how long it takes the body to eliminate them when administered orally in healthy overweight and obese participants.

In addition, the effect of the orforglipron tablet on the amount of simvastatin that enters the bloodstream and how long it takes the body to eliminate it will be evaluated.

The study will also assess the effect of sodium bicarbonate when administered alone with simvastatin versus orforglipron capsule containing sodium bicarbonate administered with simvastatin.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: have any type of diabetes with hemoglobin a1c (hba1c) level of 6.5 percent (%) or greater; obesity induced by other endocrine disorders, such as cushing's syndrome or prader-willi syndrome; have undergone bariatric surgery (for example: lap-band, gastric bypass).

How the Study Was Run

The set-up was non-randomized, sequential and open-label.

Everyone knew when Orforglipron (Foundayo, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-01-02 with completion listed for 2024-07-10.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid Following Staggered Administration of Orforglipron Capsule Formulation (Cohort 1 and 2). PK: AUC [0-∞] of Simvastatin and Its Metabolite Simvastatin Acid After Sodium Bicarbonate Coadministration (Cohort 1 and 2). PK: AUC [0-∞] of Digoxin (Cohort 1 and 2).

It also tracked 2 secondary outcomes, for example PK: Cmax of Simvastatin and Its Metabolite Simvastatin Acid Following Administration of Orforglipron Tablet Formulation (Cohort 1 and 2).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Orforglipron (Foundayo, non-peptide) in 50 people.

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.