LIRAGLUTIDE for Knee osteoarthritis | Knee synovitis

Inclusion criteria

• {"criterion_text":"- Male and female participants can take part in this study if they: • are aged between 40 and 80 years,\n- • weigh over 40 kilograms (kg),\n- • have a body mass index (BMI, the ratio of height to bodyweight) between 18.5 and 35,\n- • are able to walk unaided, or with the assistance of a cane,\n- • have had OA pain in the knee to be treated for at least 6 months before taking part,\n- • have synovitis of the knee to be treated, assessed by magnetic resonance imaging (MRI), and\n- • meet certain requirements related to their OA/synovitis diagnosis and pain levels.\n- Please see protocol for a detailed list of inclusion criteria."}

Exclusion criteria

• {"criterion_text":"- Pregnant or breastfeeding women.\n- Treatment with systemic corticosteroids (other than IA) at a dose greater than 10 mg prednisone or the equivalent per day for more than 7 days within 4 weeks prior to the screening visit.\n- Please see protocol for a detailed list of exclusion criteria.\n- Significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the TK (varus > 10°, valgus > 10°) by radiography.\n- Secondary OA such as joint dysplasia, aseptic osteonecrosis, joint infection, acromegaly, Paget disease, hemochromatosis, joint crystal disease or any inflammatory joint disease.\n- Any known active infections including skin infections at the site injection or increased predisposition for the development of infections.\n- Any partial knee replacement of the TK.\n- Acute fracture or IA trauma to the TK within 12 months prior to the screening visit.\n- Major knee surgery performed within the previous 12 months or planned during the trial.\n- Arthroscopy of the TK within 6 months prior to the screening visit.\n- Presence of any painful conditions that could confound accurate assessment of pain from OA in the TK, such as fibromyalgia, peripheral neuropathy or vascular insufficiency."}

Primary endpoints

• {"endpoint_text":"- Change from Baseline at W4 in the weekly average of TK daily pain intensity using the WOMAC Pain subscore","definition_or_measurement_approach":"Change from baseline at Week 4 in the weekly average of target knee (TK) daily pain intensity measured using the WOMAC Pain subscore."}

Secondary endpoints

• {"endpoint_text":"- Change from Baseline at W2, W6, W8, W10 and W12: -\tWeekly average of TK daily pain (WOMAC Pain)","definition_or_measurement_approach":"Change from baseline at Weeks 2, 6, 8, 10 and 12 in the weekly average of target knee daily pain measured using the WOMAC Pain subscore."}
• {"endpoint_text":"- Change from Baseline at W2, W4, W8 and W12: - NRS (0-10) pain in a nominated pain aggravating activity - WOMAC subscores and total score - Patient Global Assessment of OA (PGA-OA)","definition_or_measurement_approach":"Change from baseline at Weeks 2, 4, 8 and 12 in: NRS (0-10) pain during a nominated pain-aggravating activity; WOMAC subscores and total score; Patient Global Assessment of OA."}
• {"endpoint_text":"- % of OMERACT-OARSI Responders at W2, W4, W8 and W12","definition_or_measurement_approach":"Proportion of participants meeting OMERACT-OARSI responder criteria at Weeks 2, 4, 8 and 12."}
• {"endpoint_text":"- Incidence and severity of TEAEs during the trial","definition_or_measurement_approach":"Recording and assessment of treatment-emergent adverse events (TEAEs) by incidence and severity throughout the trial."}
• {"endpoint_text":"- Absolute values and changes from Baseline in: - Clinical laboratory assessments (hematology, chemistry, and urinalysis) - Vital signs (systolic and diastolic blood pressure [BP], pulse rate,)","definition_or_measurement_approach":"Absolute values and change from baseline in clinical laboratory parameters (hematology, chemistry, urinalysis) and vital signs (systolic/diastolic BP, pulse) at scheduled timepoints."}
• {"endpoint_text":"- Directed physical examination","definition_or_measurement_approach":"Findings from directed physical examinations performed at scheduled visits."}

Methods

• Spain: Banner ads (patient) — K2_Recruitment material banner ads patient_ES; Social media ads — K2_Recruitment material social media ads_ES; Patient brochure — K2_Recruitment material patient brochure_ES (target audience: patients).
• Poland: Patient brochure — K2_Recruitment material Patient Brochure_PL; Banner ads — K2_Recruitment material Banner Ads Patient_PL; Social media ads — K2_Recruitment material Social Media Ads_PL (target audience: patients).
• Denmark: Banner ads — K2_Recruitment material_Banner_ads_DK; Social media ads — K2_Recruitment material_Social_media_ads_DK; Patient brochure — K2_Recruitment material_Patient_brochure_DK (target audience: patients).
• France: Recruitment arrangement form and recruitment materials including patient brochure, banner and social media material (documents K1/K2 and recruitment arrangement form) (target audience: patients).

Spain

Earliest CTIS Part Ii Submission Date

30-07-2025

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

15

Number Of Sites

7

Number Of Participants

38

Poland

Earliest CTIS Part Ii Submission Date

10-07-2025

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

39

Number Of Sites

4

Number Of Participants

15

Denmark

Earliest CTIS Part Ii Submission Date

24-07-2025

Latest Decision Or Authorization Date

07-08-2025

Processing Time Days

14

Number Of Sites

2

Number Of Participants

16

France

Earliest CTIS Part Ii Submission Date

14-07-2025

Latest Decision Or Authorization Date

06-08-2025

Processing Time Days

23

Number Of Sites

5

Number Of Participants

15

Primary sponsor

Full Name

4moving Biotech

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Syneos Health UK Limited

Responsibilities

codes: 1,10,11,12,13,14,2,3,5,6,7,8

Name

Syneos Health Inc.

Responsibilities

Biomarker analysis; code:4

Name

Almac Clinical Services Limited

Responsibilities

IP and ancillaries supplies

Name

Signant Health LLC

Responsibilities

eCOA; code:7

Name

Bioclinica Inc.

Responsibilities

centralized MRI

Name

Tools4Patient

Responsibilities

placebell - covariate analysis. Score for placebo effect; code:7

Name

Bioxydyn Limited

Responsibilities

Centralized MRI

Third parties

• {"country":"United Kingdom","full_name":"Syneos Health UK Limited","duties_or_roles":"codes: 1,10,11,12,13,14,2,3,5,6,7,8","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"IP and ancillaries supplies","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Tools4Patient","duties_or_roles":"placebell - covariate analysis. Score for placebo effect; code:7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"eCOA; code:7","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"centralized MRI","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Biomarker analysis; code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Bioxydyn Limited","duties_or_roles":"Centralized MRI","organisation_type":"Pharmaceutical company"}