Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Maintenance

Study Overview
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Brief Summary
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This is a substudy to a randomized 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 they will be randomized 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 biomarkers in obese patients with knee osteoarthritis following a randomization to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.

Official Title
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Biomarkers in Obese Patients With Knee Osteoarthritis Following Long-term Weight Maintenance

Conditions
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Osteoarthritis, Obesity

Intervention / Treatment
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* Drug: Liraglutide 3 mg (Saxenda)
* Drug: Liraglutide 3 mg placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Same as parent trial (NCT02905864) Exclusion Criteria: Same as parent trial (NCT02905864)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide 3 mg<br>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)<br> <br> |
| Placebo Comparator: Liraglutide 3 mg placebo<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in collagen II degradation fragment α-C2M | Blood sampling | Week 0 to 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in collagen II degradation fragment β-C2M | Blood sampling | Week 0 to 52 | 
| Change in non-coding RNA type snoRNAs U38 and U48 | Blood sampling | Week 0 to 52 | 
| Change in miRNA-454 | Blood sampling | Week 0 to 52 | 
| Change in miRNA let-7e | Blood sampling | Week 0 to 52 | 
| Change in Nesfatin-1 | Blood sampling | Week 0 to 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Obesity, Liraglutide 3 mg, Liraglutide, Biomarkers