Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Maintenance

NCT ID: NCT02928614

Last Updated: 2019-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-03-31

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.

Conditions

Osteoarthritis; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Liraglutide 3 mg (Saxenda)

Intervention Type: 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.

Group Type: PLACEBO_COMPARATOR

Liraglutide 3 mg placebo

Intervention Type: DRUG

Interventions

Liraglutide 3 mg (Saxenda)

Intervention Type: DRUG

Liraglutide 3 mg placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Same as parent trial (NCT02905864)

Exclusion Criteria

• Same as parent trial (NCT02905864)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henrik Gudbergsen

OTHER

Sponsor Role: lead

Responsible Party

Henrik Gudbergsen

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Parker Institute

Frederiksberg, Capital Region, Denmark

Countries

Denmark

Other Identifiers

137.08

Identifier Type: -

Identifier Source: org_study_id