Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance (IM-LOSEIT-II)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Osteoarthritis
• Intervention / Treatment: Drug: Liraglutide 3 mg (Saxenda); Drug: Liraglutide 3 mg placebo

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Frederiksberg, Capital Region, Denmark, 2000
      • The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Same as parent trial (NCT02905864)

Further Exclusion Criteria:

• Same as parent trial (NCT02905864)
• Usual exclusion criteria for MRI (i.e. pacemakers etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liraglutide 3 mg; Arm description: Subjects will be up titrated to liraglutide 3 mg QD and stay on that dose for the remainder of the 52-week drug intervention period. Drug: Liraglutide 3 mg QD administered in a 6 mg/mL, 3 mL pen for subcutaneous injection. Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks.	Drug: Liraglutide 3 mg (Saxenda)
Placebo Comparator: Liraglutide 3 mg placebo; Arm description: Subjects will be up titrated to liraglutide 3 mg placebo QD and stay on that dose for the remainder of the 52-week drug intervention period. Drug: Liraglutide 3 mg placebo QD administered in a 6 mg/mL drug equivalent volumes, 3 mL pen for subcutaneous injection. Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks.	Drug: Liraglutide 3 mg placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the degree of inflammation in the knee-joint (CE-MRI)	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.)	Week 0 to 52
Change in the degree of inflammation in the knee-joint (MRI)	Change will be assessed via a conventional MRI evaluation of the level of synovitis and effusion (combined) in the knee-joint (MOAKS)	Week 0 to 52
Change in cartilage composition	Change will be assessed via T2-maps of cartilage in the weight-bearing parts of the knee-joint (ROI)	Week 0 to 52
Change in bone marrow lesions	Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score	Week 0 to 52

Collaborators and Investigators

• Sponsor: Henrik Gudbergsen

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): March 20, 2019

Study Registration Dates

• First Submitted: October 7, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Osteoarthritis; Liraglutide; Liraglutide 3 mg; Magnetic resonance imaging; Dynamic contrast enhanced MRI
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: 137.05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No