A Study of LY3437943 in Healthy Participants and Participants With Impaired Renal Function

What Was Tested

In this phase 1 trial, researchers set out to test Retatrutide.

The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy participants.

The study will last up to 5 weeks, excluding screening.

It had three arms (groups): LY3437943 (Control) (experimental), LY3437943 (Severe Renal Impairment) (experimental) and LY3437943 (End-Stage Renal Disease) (experimental).

LY3437943 administered subcutaneous (SC) to participants with normal renal function.

LY3437943 administered SC to participants with severe renal impairment.

LY3437943 administered SC to participants with end-stage renal disease.

The registry classes the interventions as drug.

Who Took Part

The registry lists 29 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

The full record lists 8 inclusion and 4 exclusion criteria; among the exclusions: have known allergies to ly3437943 or related compounds; have a current, functioning organ transplant. nonfunctional renal allografts may be allowed; have any abnormality in the 12-lead electrocardiogram (ecg).

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2022-11-16 with completion listed for 2023-09-05.

It ran at 4 sites in United States (4).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: PK: Maximum observed concentration (Cmax) of LY3437943 (time frame: Predose up to 31 days postdose).

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Retatrutide in 29 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.