A Study of LY3025876 in Participants With Diabetes

What Was Tested

The trial (phase 1) is built around Liraglutide.

The main purpose of this study is to assess the safety and tolerability of LY3025876 given alone (Part A) and in combination with liraglutide (Part B) in participants with type 2 diabetes mellitus (T2DM).

It had four arms (groups): LY3025876 (experimental), Placebo (placebo comparator), LY3025876 + Liraglutide (experimental) and Placebo + Liraglutide (placebo comparator).

Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days.

The registry classes the interventions as drug.

More on the Plan

This study will also evaluate how much of the study drug enters the blood stream and how long it takes for the body to remove the study drug.

Information about any side effects that may occur will also be collected.

Each part of the study is expected to last 10 to 12 weeks on average, not including screening.

Participants may only enroll in one part.

Who Took Part

The registry lists 72 actual participants took part.

It was open to people of any sex aged from 21 years up to 70 years.

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

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: have taken ly3025876 or investigational drugs like it (for example, other fibroblast growth factor-21 \[fgf21\]-related drugs) or have known allergies to these drugs; history or presence of bone disease (including osteoporosis or unhealed fractures); current active treatment of periodontal disease.

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.

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

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

Those kept unaware of assignments: participant and investigator.

It started in 2013-06 with completion listed for 2014-12.

It ran at 4 sites in United States (4).

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: Predose on Day 1 up to Day 56 in each Part).

It also tracked 4 secondary outcomes, for example PK: Maximum Concentration (Cmax) of LY3025876 and Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 72 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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