IM-LOSEIT-II

CompletedPhase 4

Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance

Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation

Lead sponsor

Henrik Gudbergsen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

150

estimated

Study population

Obesity / overweight, Osteoarthritis

Key I/E criterion

—

Primary endpoint

•The degree of inflammation in the knee-joint (DCE-MRI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02928679

Org study ID137.05

Timeline

Milestones

Study first posted2016-10-10estimated

Primary completion2019-02-20actual

Study completion2019-03-20actual

Last update posted2019-03-25actual

Study start2016-11 (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightOsteoarthritis

Eligibility

Who can enroll

Minimum age18 Years

Maximum age74 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

•Same as parent trial (NCT02905864)

Further Exclusion Criteria:

•Same as parent trial (NCT02905864)

•Usual exclusion criteria for MRI (i.e. pacemakers etc.)

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Change in the degree of inflammation in the knee-joint (DCE-MRI)

Time frame:Week 0 to 52