A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

What Was Tested

This registered phase 1 trial tested Retatrutide.

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants.

This study will last up to approximately 25 weeks for each participant.

It had 1 arm (groups): LY3437943 + Drug Cocktail (experimental).

Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1. At weeks 8, 12, \& 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2.

The registry classes the interventions as drug.

Who Took Part

The registry lists 32 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²). Male and female participants of childbearing potential who agree to use contraceptive methods.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: have a history of diabetes or current diagnosis of diabetes.

How the Study Was Run

Design: non-randomized, sequential and open-label.

Being open-label, the Retatrutide study did not mask who received what.

It started in 2022-07-08 with completion listed for 2023-02-24.

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

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: PK: Maximum Observed Concentration (Cmax) of Midazolam (time frame: Predose up to 24 hours postdose). PK: AUC[0-∞] of Warfarin (time frame: Predose up to 96 hours postdose). PK: Cmax of Warfarin (time frame: Predose up to 96 hours postdose).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Retatrutide in 32 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Retatrutide compound page, all human trials.