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BIO-LOSEIT-I

UnknownPhase NA

Biomarkers in Obese Patients With Knee Osteoarthritis; Weight Loss

Biomarkers in Obese Patients With Knee Osteoarthritis Following a Significant Weight Loss

Lead sponsor

Henrik Gudbergsen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

200

estimated

Study population

Obesity / overweight, Osteoarthritis

Key I/E criterion

—

Primary endpoint

•Collagen II degradation fragment α-C2M

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 IDNCT02931344

Org study ID137.04

Timeline

Milestones

Study first posted2016-10-13estimated

Last update posted2018-04-23actual

Study start2016-11 (month precision)

Primary completion2019-01estimated (month precision)

Study completion2019-06estimated (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

Inclusion criteria

•Same as parent trial (NCT02905864)

Exclusion criteria

•Same as parent trial (NCT02905864)

Endpoints (6)

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 (unclassified)

6 endpoints

Primary/protocol endpoint/low confidence

Change in collagen II degradation fragment α-C2M

Time frame:Week -8 to 0