A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

What Was Tested

The trial (phase 1) is built around Dulaglutide.

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with type 2 diabetes mellitus (T2DM).

Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it.

This is a 2-part study and will last approximately 16 weeks excluding screening period for each part, respectively.

It had five arms (groups): LY3532226 + Dulaglutide (Part A) (experimental), Placebo + Dulaglutide (Part A) (placebo comparator), Dulaglutide + Placebo (Part B) (active comparator), LY3532226 + Dulaglutide (Part B) (experimental) and LY3532226 + Placebo (Part B) (experimental).

LY3532226 administered subcutaneously (SC) followed by dulaglutide administered SC.

Placebo administered SC followed by dulaglutide administered SC.

Dulaglutide administered SC in combination with placebo given SC.

The registry classes the interventions as drug.

Who Took Part

The registry lists 90 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening. Have the following glycosylated hemoglobin (HbA1c) levels at screening:. Participants with body weight up to 150 kilograms (kg) and body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m²).

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: participants who have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening; have obesity induced by other endocrine disorders such as cushing's syndrome or prader-willi syndrome; are on any glucose-lowering medications other than metformin, sglt-2 inhibitors and/or dpp4.

How the Study Was Run

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

The participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

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 2022-06-07 with completion listed for 2024-01-12.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Part A: 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 16). Part B: Change from Baseline in Total Clamp Disposition Index (cDI) (time frame: Baseline up to Week 12).

It also tracked 8 secondary outcomes, for example Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226, Part B: Change from Baseline in Insulin Secretion Rate (ISR) from hyperglycaemic clamp, Part B: Change from Baseline in β-cell Glucose Sensitivity (GS) from hyperglycaemic clamp, Part B: Change from Baseline in Hyperinsulinemic Euglycemic Clamp M-value, Part A & B: Change from Baseline in Fasting and Post meal Glucose during Standardized Mixed-meal Tolerance Test (sMMTT) and Part A & B: Change from Baseline in Glycosylated Haemoglobin (HbA1c).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Dulaglutide in 90 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.