A Study of LY3457263 in Healthy Participants and Participants With Type 2 Diabetes

What Was Tested

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

The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 in healthy participants and participants with type 2 diabetes.

Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

The study has two parts (part A and B).

It had four arms (groups): LY3457263 - Part A (experimental), Placebo - Part A (placebo comparator), LY3457263 - Part B (experimental) and Placebo - Part B (placebo comparator).

Placebo administered SC to healthy participants.

The registry classes the interventions as drug.

Who Took Part

67 actual participants took part.

It was open to people of any sex aged from 20 years up to 65 years.

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

Examples of who could join: Females that are not of childbearing potential due to postmenopausal status or due to surgical sterility. Part A only:. Are overtly healthy. Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²). Part B only:.

The full record lists 9 inclusion and 22 exclusion criteria; among the exclusions: have undergone any form of bariatric surgery; have used or intend to use medications that promote weight loss within 3 months prior to screening, for the duration of the study; part a only:.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Dulaglutide and who got the comparison, which limits bias.

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

Blinding on both sides kept the participants and researchers unaware of who received Dulaglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2020-11-25 with completion listed for 2021-12-21.

It ran at 2 sites in Germany (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 42).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 67 people.

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

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