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A Trial to Investigate the Safety and Efficacy of Intra-articular 4P004 Injection in Subjects With Knee Synovitis and Osteoarthritis

NCT07225829 · Recruiting

Last updated 2026-05-28

This clinical trial is testing an injection called 4P004 in the knee to see if it is safe and effective for adults with knee osteoarthritis and inflammation.

Status Recruiting Currently enrolling participants.
Phase Phase 2 Tests whether it works and watches safety in a moderate group.
Type Interventional (clinical trial)
Design Randomized, double-blind treatment study
Participants 129 people Planned (estimated).
Who can join Ages 40–80 · all sexes
Timeline Started 2025-06 · est. completion 2026-09
Where 22 sites · Canada, Denmark, France, Poland, Spain, United States

What this study is testing ClinicalTrials.gov NCT07225829 ↗

Description as written by the study sponsor.

This phase 2a trial is an international, multicenter, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of one single intra-articular (IA) injection of 4P004 or placebo in: * patients between 40 and 80 years of age, * with synovitis and grade 2 to 4 osteoarthritis (OA) of the knee according to Kellgren and Lawrence (KL) classification.

Treatments tested

Main thing measuredChange from Baseline at Week 4 in the weekly average of Target Knee (TK) daily pain intensity using the WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain subscore
Sponsor4Moving Biotech
Conditions studiedKnee Osteoarthritis, Synovitis of Knee
GLP-1 drugs

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07225829 ↗