Phase 2a Trial to Test the Safety and Effectiveness of Vutiglabridin for Treating Knee Osteoarthritis in Adults Aged 40 to 75

What this Trial Is About

Researchers are evaluating the safety and effectiveness of vutiglabridin in adults aged 40 to 75 years with knee osteoarthritis. This Phase 2a trial is designed as a randomized, double-blind, placebo-controlled study to explore how vutiglabridin may help reduce knee pain and improve symptoms in patients who meet specific clinical and radiographic criteria for knee osteoarthritis. Participants will be randomly assigned to one of three groups receiving a daily oral dose of vutiglabridin 600 mg, vutiglabridin 1000 mg, or a placebo. Treatment lasts for 26 weeks, with patients taking their assigned study drug once daily. The study includes extensive monitoring and assessments such as pain evaluations using a 100 mm visual analog scale VAS, WOMAC pain subscale, X-rays, MRI scans, and body mass index measurements. During the trial, participants will undergo regular safety evaluations including vital signs, ECGs, lab tests, pregnancy tests for women, and physical exams. Blood samples will be collected to study the drugs behavior in the body. Researchers will measure changes in pain from baseline to week 26 as the primary outcome, along with other pain-related measures at multiple time points. The total duration of participation is approximately 26 weeks, with ongoing monitoring for adverse events and treatment tolerability throughout the study period.

A Study to Assess the Efficacy and Safety of Vutiglabridin in Knee Osteoarthritis Patients