Knee Osteoarthritis (Knee OA)Phase 2NCT06845553
A Study to Assess the Efficacy and Safety of Vutiglabridin in Knee Osteoarthritis Patients
A Phase 2 study testing Vutiglabridin in people with Knee Osteoarthritis (Knee OA), run by Glaceum at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Vutiglabridin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Aug 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- 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.
- Has used medications that can alter reproductive hormone levels (e.g., anabolic steroids, androgens, anti-estrogens, glucocorticoids, opiates, etc.) within 6 months (26 weeks) before screening.
- Has a history of organ transplantation.
- Has clinically significant liver dysfunction (e.g., AST or ALT more than 2.5 times the upper limit of normal, total bilirubin more than twice the upper limit of normal [except documented Gilbert's syndrome]) or kidney dysfunction (GFR <60 mL/min).
- Tests positive for HBsAg, HCV Ab, HIV Ag/Ab, or VDRL (RPR) at screening.
- Has a history of malignant tumors within the past 5 years (except for those with completely treated basal cell carcinoma, in situ carcinoma, thyroid cancer, or squamous cell carcinoma of the skin, based on the investigator's medical judgment).
- Has used systemic steroids for 7 or more consecutive days within 3 months (13 weeks) before screening.
- Has taken immunosuppressive drugs including methotrexate or antimetabolites within 3 months (13 weeks) before screening.
- Taking drugs that are substrates of the breast cancer resistant protein (BCRP) (e.g., rosuvastatin, sulfasalazine) at screening (however, can be eligible if switched to a different drug in the same class).
- Has a history of alcohol or drug abuse within 2 years before screening or tests positive for substance abuse at screening (except for documented chronic pain treatment with prescribed medications approved by the investigator).
- Has participated in another clinical trial or bioequivalence study within 6 months (26 weeks) before the first dose and received investigational medicinal products (except for placebo).
- Has a history of hypersensitivity or allergic reactions to any components of the investigational medicinal product.
- Has lactose intolerance.
- Unwilling to use medically acceptable contraception during the clinical trial period and for 90 days after the last dose.
- Medically acceptable contraception includes:
- Oral hormonal contraceptives for female partners of male subjects.
- Intrauterine devices with proven pregnancy failure rate.
- Surgical sterilization (e.g., vasectomy, tubal ligation, hysterectomy).
- Unwilling to donate sperm/eggs during the trial or for 90 days after the last dose.
- Deemed unsuitable for participation in the trial based on clinical laboratory results or other reasons determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
About this study
Official title: 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
- Study Objective To Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients
- 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
- 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)
- Being tested
- Vutiglabridin, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VutiglabridinDrug
Also called HSG4112,2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol
Once-daily oral administration
PlaceboDrug
Once-daily oral administration
| Study group | Role | What they receive |
|---|---|---|
| Vutiglabridin 600 mg Multiple Dose | Experimental | Multiple oral dosing of Vutiglabridin 600 mg for 26 weeks Receives: Drug: Vutiglabridin |
| Vutiglabridin 1000 mg Multiple Dose | Experimental | Multiple oral dosing of Vutiglabridin 1000 mg for 26 weeks Receives: Drug: Vutiglabridin |
| Placebo | Placebo comparator | Multiple oral dosing of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to Week 26
Secondary outcomes (6)
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 4,8,13 and 26 post-dosing.
Measured: From baseline to Week 4, 8, 13
Change from baseline in 100 mm VAS (weight-bearing)
Change from baseline (Day 1) in pain experienced during weight-bearing, as assessed by the subject using a 100 mm VAS, at Weeks 4, 8, 13, and 26 post-dosing.
Measured: From baseline to Week 4, 8, 13, 26
Change from baseline in 100 mm VAS (at rest)
Change from baseline (Day 1) in pain experienced at rest, as assessed by the subject using a 100 mm VAS, at Weeks 4, 8, 13, and 26 post-dosing.
Measured: From baseline to Week 4, 8, 13, 26
Change from baseline in 100 mm VAS (at night)
Change from baseline (Day 1) in pain experienced at night, as assessed by the subject using a 100 mm VAS, at Weeks 4, 8, 13, and 26 post-dosing.
Measured: From baseline to Week 4, 8, 13, 26
Change from baseline in WOMAC pain subscale
Change from baseline (Day 1) in the total WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) score and scores for each subscale (pain, function, and stiffness) as assessed by the subject, at Weeks 4, 8, 13, and 26 post-dosing.
Measured: From baseline to Week 4, 8, 13, 26
Subjects who reached a score of 30 mm or less on the 100 mm VAS.
The proportion of subjects who reached a pain score of 30 mm or less on the 100 mm VAS at Weeks 4, 8, 13, and 26 post-dosing, as assessed by the subject.
Measured: From baseline to Week 4, 8, 13, 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start19 Aug 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaceum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845553
- Sponsor's protocol ID
- HSG4112-P2-02
- Status last verified
- Aug 2025
- First submitted
- 20 Feb 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06845553
- Acronym / sponsor ID
- HSG4112-P2-02
- Conditions
- Knee Osteoarthritis (Knee OA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GlaceumIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Seoul National University Bundang Hospital
- Study start
- 19 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Study Objective To Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vutiglabridin 600 mg Multiple Dose | Experimental | Drug: VutiglabridinMultiple oral dosing of Vutiglabridin 600 mg for 26 weeks |
| Vutiglabridin 1000 mg Multiple Dose | Experimental | Drug: VutiglabridinMultiple oral dosing of Vutiglabridin 1000 mg for 26 weeks |
| Placebo | Placebo comparator | Drug: PlaceboMultiple oral dosing of placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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.
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VutiglabridinAlso: HSG4112,2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenolOnce-daily oral administration | Drug | Vutiglabridin 1000 mg Multiple Dose, Vutiglabridin 600 mg Multiple Dose |
| PlaceboOnce-daily oral administration | Drug | Placebo |
Primary outcome
Change from baseline in 100 mm VAS
Time frame: From baseline to Week 26
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.
6 secondary outcomes
Change from baseline in 100 mm VAS
Time frame: From baseline to Week 4, 8, 13
Change from baseline in 100 mm VAS (weight-bearing)
Time frame: From baseline to Week 4, 8, 13, 26
Change from baseline in 100 mm VAS (at rest)
Time frame: From baseline to Week 4, 8, 13, 26
Change from baseline in 100 mm VAS (at night)
Time frame: From baseline to Week 4, 8, 13, 26
Change from baseline in WOMAC pain subscale
Time frame: From baseline to Week 4, 8, 13, 26
Subjects who reached a score of 30 mm or less on the 100 mm VAS.
Time frame: From baseline to Week 4, 8, 13, 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vutiglabridin in people with Knee Osteoarthritis (Knee OA), run by Glaceum at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaejin Shin (+82-31-8002-2558, jaejin@glaceum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 100 mm VAS (time frame: From baseline to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.