A Study of LY3437943 in Healthy Participants With a High Body Mass Index

What Was Tested

This registered phase 1 trial tested Retatrutide.

The study is conducted in two parts (Part A and B).

The main purpose of this study is to look at the amount of the LY3437943 that gets into the blood stream and how long it takes the body to get rid of it when given subcutaneously (SC, under the skin) in the upper arm and thigh compared to the abdomen in healthy participants with high body mass index (BMI) in Part A.

In Part B, the participants receive LY3437943 intravenously (IV, through a vein) where the safety and tolerability of LY3437943 are evaluated and information about any side effects experienced will be collected.

It had two arms (groups): LY3437943 (Part A) (experimental) and LY3437943 (Part B) (experimental).

LY3437943 administered subcutaneously (SC) in either thigh, upper arm, or abdomen.

LY3437943 administered intravenously (IV).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 85 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.

Examples of who could join: Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures. Body mass index (BMI) between 27.0 and 45.0 kilograms per meter squared (kg/m²), inclusive. Are agreeable to receiving study treatment by injections under the skin or through a vein.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: have a history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form); have known allergies to ly3437943, related compounds, or any components of the formulation; smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day.

How the Study Was Run

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

Because people in this Retatrutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Retatrutide group and the comparison group ran side by side rather than switching.

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

It started in 2023-07-18 with completion listed for 2024-07-25.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Part A: PK: Maximum Concentration (Cmax) of LY3437943 (time frame: Predose on Day 1 up to 43 days postdose (Part A)).

It also tracked 2 secondary outcomes, for example Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943 and Part B: PK: Maximum Concentration (Cmax) of LY3437943.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Retatrutide in 85 people.

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.