A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices

What Was Tested

This registered phase 1 trial tested Retatrutide.

The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices.

The study will also evaluate the safety and tolerability of LY3437943 and information about any side effects experienced will be collected.

For each participant, the total duration of the study will be approximately 16 weeks, including screening.

It had two arms (groups): LY3437943 - Test (experimental) and LY3437943 - Reference (active comparator).

The registry classes the interventions as device and drug.

Who Took Part

57 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 non-pregnant females as determined by medical history, physical examination, and other screening procedures. Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive. Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study. Are agreeable to receiving study treatment by injections under the skin.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: smoke more than the equivalent of 10 cigarettes per day; is a known user of drugs of abuse; have known allergies to ly3437943 or related compounds.

How the Study Was Run

Design: randomized, crossover and open-label.

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.

Each person switched between Retatrutide and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Retatrutide study: the participants and staff both knew the treatment.

It started in 2023-08-29 with completion listed for 2024-02-08.

It ran at 3 sites in United States (3).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943 (time frame: Predose up to 43 days postdose). PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943 (time frame: Predose up to 43 days postdose).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Retatrutide in 57 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.