Ultrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance

What Was Tested

The trial (phase 4) is built around 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 (OA) (NCT02905864).

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 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: Informed consent obtained. Clinical diagnosis of knee OA (American College of Rheumatology (ACR) criteria) confirmed by radiology but restricted to definite radiographic OA at early to moderate-stages (Kellgren-Lawrence grades 1, 2, or 3). Age ≥ 18 years and \< 75 years. Body mass index (BMI) ≥ 27 kg/m2. Stable body weight during the previous 3 months (\< 5 kg self-reported weight change).

The full record lists 6 inclusion and 30 exclusion criteria; among the exclusions: on-going participation, or participation within the last 3 months, in an organised weight loss programme (or within the last 3 months); current use or use within three months before this trial of glp-1 receptor agonist, pramlintide, sibutramine, orlistat, zonisamide, topiramate, or phentermine; type 1 diabetes.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

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

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

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in the degree of inflammation in the knee-joint (Greyscale-score) (time frame: Week 0 to 52).

It also tracked 3 secondary outcomes, for example Change in knee-joint effusion, Change in the degree of inflammation in the knee-joint (Greyscale-size) and Change in the degree of inflammation in the knee-joint (Doppler-score).

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.