Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864).

It had two arms (groups): one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 150 planned participants were the target.

It was open to people of any sex aged from 18 years up to 74 years.

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

Examples of who could join: Same as parent trial (NCT02905864).

The full record lists 1 inclusion and 2 exclusion criteria; among the exclusions: same as parent trial (nct02905864); usual exclusion criteria for mri (i.e. pacemakers etc.).

How the Study Was Run

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

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

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

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-11 with completion listed for 2019-02-20.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in the degree of inflammation in the knee-joint (DCE-MRI) (time frame: Week 0 to 52).

It also tracked 4 secondary outcomes, for example Change in the degree of inflammation in the knee-joint (CE-MRI), Change in the degree of inflammation in the knee-joint (MRI), Change in cartilage composition and Change in bone marrow lesions.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 150 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.