A Study of LY3841136 in Healthy and Overweight Participants

What Was Tested

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

The main purpose of this study is to evaluate the safety and tolerability of LY3841136 in healthy and overweight participants.

Blood tests will be performed to check how much LY3841136 gets into the bloodstream and how long it takes the body to eliminate it.

This is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts A and B, respectively.

It had four arms (groups): LY3841136 (Part A) (experimental), LY3841136 (Part B) (experimental), Placebo (Part A) (placebo comparator) and Placebo (Part B) (placebo comparator).

Placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 148 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Have had a stable weight for the last 3 months.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: are women who are lactating; have known allergies to related compounds of ly3841136 or any components of the formulation; have been diagnosed with type 1 or type 2 diabetes mellitus.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

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

As a double-blind Eloralintide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2022-03-30 with completion listed for 2024-01-25.

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

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Predose up to 14 weeks (Part A) & 28 weeks (Part B)).

It also tracked 3 secondary outcomes, for example PK: Maximum Observed Concentration (Cmax) of LY3841136.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Eloralintide in 148 people.

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

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