Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Trial to Evaluate the Safety and Efficacy of Vutiglabridin in Knee Osteoarthritis Patients with 26 Weeks of Oral Treatment
Led by Glaceum · Updated on 2025-08-15
60
Participants Needed
1
Research Sites
21 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
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 drug's 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.
CONDITIONS
Brief 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.
- Meets ACR criteria for osteoarthritis with symptoms over 3 months requiring treatment.
- Has knee pain and radiographic evidence of osteophytes plus age 50 or older, or morning stiffness under 30 minutes, or crepitus on knee movement.
- Kellgren-Lawrence grade II or III in the 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 natural amenorrhea or FSH level).
You will not qualify if you...
- BMI of 35.0 kg/m² or higher.
- New significant disease within 4 weeks before or during screening.
- Arthritis in joints other than the knee.
- Any other joint disease besides knee osteoarthritis.
- History of knee or other joint surgery.
- Knee injections with steroids or hyaluronic acid within specified recent time frames.
- Use of pain or symptom control drugs for knee within 4 weeks prior to study drug.
- Expected surgery during trial affecting completion.
- Neuropathic pain or recent use of neuropathic pain medications.
- Recent history of serious cardiovascular events within 3 months.
- Untreated or unstable significant diseases or psychiatric disorders.
- Male history of hypogonadism or infertility conditions.
- Use of medications altering reproductive hormones within 6 months.
- History of organ transplantation.
- Significant liver or kidney dysfunction.
- Positive tests for certain infections at screening.
- History of malignant tumors within 5 years except certain skin and thyroid cancers.
- Recent use of systemic steroids or immunosuppressive drugs.
- Use of drugs that are substrates of breast cancer resistant protein unless switched.
- History or current substance abuse.
- Recent participation in other clinical trials with investigational drugs.
- History of allergic reactions to study drug components.
- Lactose intolerance.
- Unwillingness to use acceptable contraception or donate sperm/eggs during and after trial.
- Deemed unsuitable by investigator based on clinical or lab findings.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive once-daily oral dosing of either Vutiglabridin or placebo for knee osteoarthritis.
Visits at baseline and Weeks 4, 8, 13, and 26
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
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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