Actively Recruiting
A Study to Assess the Efficacy and Safety of Vutiglabridin in Knee Osteoarthritis Patients
Led by Glaceum · Updated on 2025-08-15
60
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
Sponsors
G
Glaceum
Lead Sponsor
S
Seoul National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess the Efficacy and Safety of Vutiglabridin in Knee Osteoarthritis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agreed to participate and signed informed consent.
- Adults aged 40 to 75 years at screening.
- Meet American College of Rheumatology criteria for osteoarthritis with symptoms over 3 months needing treatment.
- Have knee pain and X-ray evidence of osteophytes plus at least one of: age 50 or older, morning stiffness under 30 minutes, or crepitus on knee motion.
- Kellgren-Lawrence grade II or III in knee joint on X-ray.
- Maximum pain of 50 mm or greater on 100 mm VAS during activity in past 24 hours.
- For females: negative pregnancy test if of childbearing potential, not breastfeeding, surgically sterilized or postmenopausal (defined by amenorrhea and hormone levels).
You will not qualify if you...
- Body mass index (BMI) 35.0 kg/m² or higher.
- New significant disease within 4 weeks before or during screening.
- Arthritis in joints other than the knee.
- Other joint diseases except knee osteoarthritis.
- History of knee or other joint surgery.
- Steroid injections within 3 months or hyaluronic acid injections within 3 or 6 months in affected knee.
- Pain control or symptom treatment in knee within 4 weeks before study drug.
- Planned surgery during trial that affects completion.
- Neuropathic pain or medications for it within 4 weeks before screening.
- History of recent heart attack, unstable angina, stroke, or blood clots within 3 months.
- Untreated or unstable significant diseases.
- For males: history of hypogonadism, infertility, or related conditions.
- Use of hormone-altering medications within 6 months before screening.
- History of organ transplant.
- Significant liver or kidney dysfunction.
- Positive tests for hepatitis B, C, HIV, or syphilis.
- History of cancer within 5 years except certain treated skin or thyroid cancers.
- Use of systemic steroids for 7 or more days within 3 months.
- Use of immunosuppressive drugs within 3 months.
- Use of certain drugs interacting with study medication unless switched.
- History or positive test for substance abuse within 2 years.
- Participation in another clinical trial within 6 months with investigational drugs.
- Allergy to study drug components.
- Lactose intolerance.
- Unwillingness to use medically acceptable contraception during and 90 days after trial.
- Unwillingness to donate sperm or eggs during and 90 days after trial.
- Unsuitable for participation based on lab results or investigator judgment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Actively Recruiting
Research Team
J
Jaejin Shin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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