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

Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02928679

Acronym

IM-LOSEIT-II

Enrollment

150

Registered

2016-10-10

Start date

2016-11-30

Completion date

2019-03-20

Last updated

2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Osteoarthritis

Keywords

Magnetic resonance imaging, Dynamic contrast enhanced MRI, Liraglutide 3 mg, Liraglutide, Obesity, Osteoarthritis

Brief summary

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). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle. This substudy aims to investigate the impact of, and subsequent change of, joint inflammation, articular cartilage composition, overall knee morphology, and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.

Interventions

DRUGLiraglutide 3 mg (Saxenda)

DRUGLiraglutide 3 mg placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

Inclusion criteria

* Same as parent trial (NCT02905864) Further

Exclusion criteria

* Same as parent trial (NCT02905864) * Usual

Design outcomes

Primary

Measure	Time frame	Description
Change in the degree of inflammation in the knee-joint (DCE-MRI)	Week 0 to 52	Change will be assessed via a dynamic contrast enhanced MRI evaluation of corpus hoffa (Ballegaard C et al. and Riis RG et al.)

Secondary

Measure	Time frame	Description
Change in the degree of inflammation in the knee-joint (MRI)	Week 0 to 52	Change will be assessed via a conventional MRI evaluation of the level of synovitis and effusion (combined) in the knee-joint (MOAKS)
Change in cartilage composition	Week 0 to 52	Change will be assessed via T2-maps of cartilage in the weight-bearing parts of the knee-joint (ROI)
Change in the degree of inflammation in the knee-joint (CE-MRI)	Week 0 to 52	Change will be assessed via a static contrast enhanced MRI evaluation of the level of synovitis in the knee-joint (11 sites scored 0-2, ad modum Guermazi et al.)
Change in bone marrow lesions	Week 0 to 52	Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026