Liraglutide [amount hidden] for Knee Osteoarthritis

What Was Tested

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

Patients will be subjected to a run-in diet intervention phase (week -8 to 0) including a low-calorie diet and dietetic counselling.

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.

The full record lists 6 inclusion and 30 exclusion criteria; among the exclusions: 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; type 2 diabetes treated with glucose-lowering drugs other than metformin.

How the Study Was Run

Design: randomized, parallel-group and quadruple-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.

The Liraglutide 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 Liraglutide.

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

Researchers chose this as the main measure: KOOS pain subscale (time frame: Week 0 to 52).

It also tracked 15 secondary outcomes, for example KOOS symptom subscale, KOOS ADL subscale, KOOS sport and recreation subscale, KOOS health related QoL subscale, Change in total score in the ICOAP questionnaire and Change in the constant pain subscale in the ICOAP questionnaire.

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.