Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Maintenance

Phase 4

Completed

• Conditions: Osteoarthritis; Obesity
• Interventions: Drug: Liraglutide 3 mg (Saxenda); Drug: Liraglutide 3 mg placebo

• Registration Number: NCT02928614
• Lead Sponsor: Henrik Gudbergsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-07
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-10
• Study Start: 2016-11
• Primary Completion: 2019-02
• Status Verified: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Same as parent trial (NCT02905864)

Exclusion Criteria

• Same as parent trial (NCT02905864)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide 3 mg	Liraglutide 3 mg (Saxenda)	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.
Liraglutide 3 mg placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in collagen II degradation fragment α-C2M	Week 0 to 52	Blood sampling

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Parker Institute; 🇩🇰 Frederiksberg, Capital Region, Denmark