Biomarkers in Obese Patients With Knee Osteoarthritis Following Long-term Weight Maintenance
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Henrik Gudbergsen
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in collagen II degradation fragment α-C2M
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Same as parent trial (NCT02905864)
Exclusion Criteria
- •Same as parent trial (NCT02905864)
Arms & Interventions
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.
Intervention: Liraglutide 3 mg (Saxenda) (Drug)
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.
Intervention: Liraglutide 3 mg placebo (Drug)
Outcomes
Primary Outcomes
Change in collagen II degradation fragment α-C2M
Time Frame: Week 0 to 52
Blood sampling
Secondary Outcomes
- Change in collagen II degradation fragment β-C2M(Week 0 to 52)
- Change in non-coding RNA type snoRNAs U38 and U48(Week 0 to 52)
- Change in miRNA-454(Week 0 to 52)
- Change in miRNA let-7e(Week 0 to 52)
- Change in Nesfatin-1(Week 0 to 52)
Investigators
Henrik Gudbergsen
MD, PhD
Parker Research Institute