A Phase 4 interventional study of Liraglutide 3 mg (Saxenda) and Liraglutide 3 mg placebo in Osteoarthritis and Obesity, sponsored by Henrik Gudbergsen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-03-25.
Sponsored by Henrik Gudbergsen · Phase 4, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 150 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Henrik Gudbergsen is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Inclusion Criteria:
Further Exclusion Criteria:
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)
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
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.)
Time frame: Week 0 to 52
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.)
Time frame: 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)
Time frame: 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)
Time frame: Week 0 to 52
Change in bone marrow lesions
Change will be assessed via the MRI knee scoring system MOAKS; BML sum-score
Time frame: Week 0 to 52
Plan to share: No
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Henrik Gudbergsen