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

NCT06845553 | Recruiting Phase 2

• 1 other identifier: HSG4112-P2-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study Objective To Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients
2. 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. 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

Knee Osteoarthritis (Knee OA)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 100 mm VAS

  Change from baseline (Day 1) in the maximum pain experienced during daily activity in the past 24 hours, as assessed by the subject using a 100 mm VAS(Visual Analog Scale; 0=no pain, 100=pain as bad as you can imagine) , at Week 26 post-dosing.

  From baseline to Week 26

Secondary Outcomes (6)

• Change from baseline in 100 mm VAS

  From baseline to Week 4, 8, 13

• Change from baseline in 100 mm VAS (weight-bearing)

  From baseline to Week 4, 8, 13, 26

• Change from baseline in 100 mm VAS (at rest)

  From baseline to Week 4, 8, 13, 26

• Change from baseline in 100 mm VAS (at night)

  From baseline to Week 4, 8, 13, 26

• Change from baseline in WOMAC pain subscale

  From baseline to Week 4, 8, 13, 26

Study Arms (3)

Vutiglabridin 600 mg Multiple Dose

EXPERIMENTAL

Multiple oral dosing of Vutiglabridin 600 mg for 26 weeks

Drug: Vutiglabridin

Vutiglabridin 1000 mg Multiple Dose

EXPERIMENTAL

Multiple oral dosing of Vutiglabridin 1000 mg for 26 weeks

Drug: Vutiglabridin

Placebo

PLACEBO COMPARATOR

Multiple oral dosing of placebo

Drug: Placebo

Interventions

Vutiglabridin DRUG

Once-daily oral administration

Also known as: HSG4112,2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol

Vutiglabridin 1000 mg Multiple Dose; Vutiglabridin 600 mg Multiple Dose

Placebo DRUG

Once-daily oral administration

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• BMI of 35.0 kg/m² or higher at screening.
• Developed a clinically significant new disease within 4 weeks before screening or during the screening period, as judged by the investigator.
• Has arthritis in joints other than the knee.
• Has any other joint disease except knee osteoarthritis (e.g., secondary osteoarthritis due to trauma, congenital defects, calcium deposition diseases, rheumatoid arthritis, gouty arthritis, Paget's disease, systemic inflammatory disorders, chondrocalcinosis, hemachromatosis, inflammatory arthritis, avascular necrosis, etc.).
• Has a history of knee or other joint surgery.
• Has received injections in the affected knee before the administration of the study drug:
• Steroid injections within 3 months (13 weeks) to the knee osteoarthritis area.
• Short-acting hyaluronic acid injections within 3 months (13 weeks) to the knee osteoarthritis area.
• Long-acting hyaluronic acid injections within 6 months (26 weeks) to the knee osteoarthritis area.
• Has received drug therapy for pain control or symptom improvement in the knee joint area within 4 weeks before study drug administration (opioid analgesics, non-opioid analgesics, topical capsaicin, NSAIDs, anticonvulsants, and other treatments like physical therapy, prolotherapy, herbal treatment, glucosamine, chondroitin).
• Expected to undergo surgery during the clinical trial period that may affect study completion or adherence to the clinical protocol.
• Has neuropathic pain or has taken neuropathic pain medications (gabapentinoids, SNRIs, tricyclic antidepressants) within 4 weeks before screening.
• Has a history of myocardial infarction, unstable angina, stroke, transient ischemic attack, or deep vein thrombosis within 3 months (13 weeks) before screening.
• Has any clinically significant untreated or unstable diseases of the liver, kidney, nervous system, immune system, respiratory system, endocrine system, blood/oncologic diseases, cardiovascular diseases, psychiatric disorders, neoplastic diseases, or any other conditions deemed unsuitable for participation by the investigator.
• For males, has a history of hypogonadism or known causes of hypogonadism (e.g., prostate cancer treatment), infertility, Klinefelter syndrome, or Kalman syndrome.

Sponsors & Collaborators

• Glaceum: lead
• Seoul National University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Jaejin Shin

CONTACT

+82-31-8002-2558; jaejin@glaceum.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)