A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Phase 2a Clinical Trial to Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients Following 26 Weeks of Oral Treatment
1. Study Objective To Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients 2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of vutiglabridin in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in Knee Osteoarthritis Patients 3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled, parallel-group trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 26 weeks according to the study protocol. Several parameters (i.e., 100mm VAS, WOMAC pain subscale, X-ray, MRI, BMI) will be evaluated to assess the efficacy of vutiglabridin. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of vutiglabridin. Blood samples will be collected for pharmacokinetic assessment.
• Voluntarily agreed to participate in the study after being informed about the nature of the trial and has signed the informed consent form approved by the IRB.
• Adults aged 40 to 75 years at the time of screening.
• Meets the American College of Rheumatology (ACR) criteria for osteoarthritis and has symptoms lasting for more than 3 months requiring pharmacological treatment. Must have knee pain and radiographic evidence of osteophytes, with at least one of the following:
‣ Age 50 or older
⁃ Morning stiffness less than 30 minutes
⁃ Crepitus on knee motion
• Has a Kellgren-Lawrence grade II or III in the knee joint on X-ray at the time of screening.
• Experiences a maximum pain of 50 mm or greater on the 100 mm VAS in activity over the past 24 hours at screening and baseline.
• For females, the following conditions apply:
‣ For women of childbearing potential, the serum hCG pregnancy test at screening must be negative, confirming not pregnant.
⁃ Not currently breastfeeding.
⁃ Has undergone surgical sterilization (documented bilateral tubal ligation, bilateral tubal occlusion, bilateral oophorectomy, or hysterectomy), or is postmenopausal.
∙ Definition of menopause:
⁃ For women over 50 years: 12 months of natural amenorrhea.
⁃ For women under 50 years: Serum FSH level over 40 IU/L and 12 months of natural amenorrhea.