A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

What Was Tested

The trial (phase 1) is built around Dulaglutide.

The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in 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 will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.

It had four arms (groups): LY3457263 (Alone) (experimental), Placebo (Alone) (placebo comparator), LY3457263 + Dulaglutide (experimental) and Placebo + Dulaglutide (experimental).

LY3457263 administered subcutaneously (SC).

Placebo administered SC.

LY3457263 in combination with dulaglutide administered SC.

The registry classes the interventions as drug.

Who Took Part

94 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants with type 2 diabetes (T2D) at least 6 months before screening. Participants treated for T2D with diet and exercise, with or without metformin. Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²).

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young; have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy; have known allergies to glp-1 receptor agonists.

How the Study Was Run

Design: 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 2022-06-02 with completion listed for 2023-11-22.

It ran at 5 sites in United States (5).

Its stated primary purpose is basic science.

What Was Measured

The main thing 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 16 weeks).

It also tracked 1 secondary outcome, for example PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 94 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.