A Study of LY3537021 in Healthy Participants

What Was Tested

This registered phase 1 trial tested Liraglutide.

The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when administered in combination with glucagon-like peptide (GLP-1) receptor agonist called liraglutide in treatment-naïve healthy participants.

The study will include 2 parts.

The study will last up to 16 and 22 weeks for part A and B, respectively which includes a screening period of 6 weeks.

It had four arms (groups): LY3537021 + Liraglutide (Part A) (experimental), Liraglutide + Placebo (Part A) (experimental), LY3537021 + Liraglutide & Placebo + Liraglutide (Part B) (experimental) and Placebo + Liraglutide & LY3537021 + Liraglutide Part B) (experimental).

Liraglutide administered subcutaneously (SC) followed by liraglutide in combination with LY3537021 given SC.

Liraglutide administered SC followed by liraglutide in combination with placebo given SC.

LY3537021 administered SC followed by liraglutide administered SC in treatment period 1. Placebo administered SC followed by liraglutide administered SC in treatment period 2.

The registry classes the interventions as drug.

Who Took Part

The registry lists 47 actual participants took part.

It was open to people of any sex aged from 21 years up to 60 years.

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

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: history of malignancy within 5 years prior to screening; have undergone any form of bariatric surgery; have an abnormality in the 12-lead electrocardiogram (ecg).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

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

It ran at 1 site in Singapore.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: 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: Baseline up to Week 22).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 47 people.

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

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