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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients

A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups, Phase 2a Clinical Trial to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients

A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients (NCT06329141) is a Phase 2 interventional studying Parkinson Disease, sponsored by Glaceum. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

1. Study Objective \- To assess the efficacy and safety of vutiglabridin in early Parkindson's disease 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 early Parkinson's disease 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 24 weeks according to the study protocol. Several parameters (i.e., MDS-UPDRS, CGI-C, K-NMSS, modified Hoehn-Yahr stage and SNBR) 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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Parkinson Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 90 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Parkinson Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Able to read, understand, and provide written consent for the trial, comply with the clinical trial protocol, and communicate any adverse events (AEs) and other clinically significant information to the investigator (able to complete the evaluation, including walking or using walking aids). 2. Adult men and women between the ages of 40 and 75 at Screening. 3. Diagnosed with Parkinson's disease according to the UK Parkinson's Disease Society (UKPDS) Brain Bank clinical diagnostic criteria and confirmed the reduction of dopamine transporter on 18F-FP-CIT PET imaging at Screening. 4. Diagnosed with Parkinson's disease within the last 24 months. 5. Hoehn-Yahr stage ≤ 2 6. Eligible females will be: - females of childbearing potential who are not pregnant, evidenced by a negative serum hCG pregnancy test at Screening - non-lactating, or - surgically sterile (defined as documented bilateral tubal ligation, bilateral tubal occlusion, bilateral oophorectomy, hysterectomy) or postmenopausal. - Definition of menopause - 50 years or over: 12 or more consecutive months without menstruation, in the absence of other conditions. - Less than 50 years: FSH level is \> 40 IU/L and 12 or more consecutive months without menstruation, in the absence of other conditions. Who Should NOT Join This Trial: 1. Clinically significant new illness, per Investigator judgment, in the 4 weeks before Screening and during the screening period. 2. Global Deterioration Scale (GDS) ≥ 4 at Screening. 3. Have clinically significant depression as indicated by a Korean Beck Depression Inventory II score (K-BDI-II) \> 18 at Screening. 4. BMI less than 18.5 kg/m2 at Screening. 5. Have the following laboratory test results: - Clinically significant abnormal hepatic (i.e., AST or ALT greater than 2.5x ULN, or total bilirubin greater than 2x ULN, unless documented Gilbert's syndrome) - Renal function laboratory test (i.e., GFR \< 60 mL/min). 6. Have the following medical history: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Able to read, understand, and provide written consent for the trial, comply with the clinical trial protocol, and communicate any adverse events (AEs) and other clinically significant information to the investigator (able to complete the evaluation, including walking or using walking aids). 2. Adult men and women between the ages of 40 and 75 at Screening. 3. Diagnosed with Parkinson's disease according to the UK Parkinson's Disease Society (UKPDS) Brain Bank clinical diagnostic criteria and confirmed the reduction of dopamine transporter on 18F-FP-CIT PET imaging at Screening. 4. Diagnosed with Parkinson's disease within the last 24 months. 5. Hoehn-Yahr stage ≤ 2 6. Eligible females will be: * females of childbearing potential who are not pregnant, evidenced by a negative serum hCG pregnancy test at Screening * non-lactating, or * surgically sterile (defined as documented bilateral tubal ligation, bilateral tubal occlusion, bilateral oophorectomy, hysterectomy) or postmenopausal. * Definition of menopause * 50 years or over: 12 or more consecutive months without menstruation, in the absence of other conditions. * Less than 50 years: FSH level is \> 40 IU/L and 12 or more consecutive months without menstruation, in the absence of other conditions. Exclusion Criteria: 1. Clinically significant new illness, per Investigator judgment, in the 4 weeks before Screening and during the screening period. 2. Global Deterioration Scale (GDS) ≥ 4 at Screening. 3. Have clinically significant depression as indicated by a Korean Beck Depression Inventory II score (K-BDI-II) \> 18 at Screening. 4. BMI less than 18.5 kg/m2 at Screening. 5. Have the following laboratory test results: * Clinically significant abnormal hepatic (i.e., AST or ALT greater than 2.5x ULN, or total bilirubin greater than 2x ULN, unless documented Gilbert's syndrome) * Renal function laboratory test (i.e., GFR \< 60 mL/min). 6. Have the following medical history: * Diagnosed with or suspected to have \*Parkinson-plus syndromes (PPS) * PPS: Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Diffuse Lewy Body Disease, etc. * Tremor-dominant Parkinson's disease, per Investigator judgment. * Symptoms or signs indicative of neurological functional impairment or known abnormalities in brain CT or MRI imaging. * A history of severe heart failure (NYHA class III \~ IV), stroke, cerebral ischemic attacks, or seizures within the past year before screening; or those with a history of myocardial infarction or unstable angina within the last 6 months before screening. * Have undergone surgery for Parkinson's disease treatment (e.g., cholecystectomy, deep brain stimulation, fetal tissue transplantation) or any other major brain surgery. * Diagnosed with malignant tumors within the past 5 years before screening (except for adequately treated basal cell carcinoma, cervical intraepithelial neoplasia, thyroid cancer, or flat epithelial atypia). * Diagnosed with secondary Parkinsonism (drug-induced Parkinsonism, normal pressure hydrocephalus, vascular Parkinsonism). 7. Have swallowing problems 8. Have clinically significant dizziness, nausea, per Investigator's judgment. 9. Currently taking any of the following medications and have the willingness and ability to continue taking them throughout the clinical trial period: * Within the 4 weeks before baseline, taking any Parkinson's disease medications, including dopamine agonists, dopamine-depleting enzyme inhibitors \[monoamine oxidase inhibitors (MAOi), COMT (catechol-O-methyltransferase) inhibitors\], non-dopaminergic drugs (anticholinergic agents, amantadine, etc.), and others PD medications (In case of irreversible MAO-B inhibitor, within the 90 days before baseline) * Within the 12 weeks before screening, have used systemic steroids continuously for 7 days or longer. * Within the 12 weeks before baseline, taking levodopa or levodopa combinations (except history of levodopa use for more than 4 weeks) * Currently taking medications known to be substrates of breast cancer resistant protein (BCRP) at screening (e.g., rosuvastatin, serpalan, etc.) (Note: If switched to another drug of the same class, the subject may be eligible for inclusion). * taking of any medication within 6 months of Screening that can alter reproductive hormone levels, either as the intended effect or as a side effect, including: anabolic steroids, androstenedione, bicalutamide, cimetidine, dehydroepiandrosterone, diethylstilbestrol, other estrogens, dutasteride, finasteride, glucocorticoids (e.g., prednisone, cortisone, hydrocortisone, and decadron), oral ketoconazole, megestrol acetate, opiates (e.g., morphine, codeine, oxycodone, hydrocodone), spironolactone, testosterone or any androgen, and any medications for treating prostate cancer. 10. Have taken of stable doses of levodopa or levodopa combination 11. Have known or suspected intolerance to PET scan or fluoropropyl-CIT (18F). 12. Have a history of organ transplantation. 13. Tested positive for HBsAg, HCV Ab, HIV Ag/Ab, or VDRL(RPR) antibodies in screening tests. 14. Known hypersensitivity or contraindication to the main ingredient and excipients of the investigational product. 15. Anticipated to undergo surgery during the clinical trial period or to receive surgical interventions that may affect the completion of the trial or compliance with the clinical trial protocol. 16. Participated in a clinical trial for an investigational drug or medical device for a period equal to or longer than five times the drug's half-life at baseline or within the past 12 weeks, whichever is longer. 17. Unwilling, or whose partner is unwilling, to use a medically acceptable means of \*contraception during and for 90 days following completion/withdrawal of the study. * Medically acceptable contraceptive methods include: * intrauterine device that has been proven highly effective, used by the subject or the subject's spouse/partner * physical contraception (male or female) used with chemical sterilization surgical sterilization of the subject or the subject's partner (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy * oral hormonal contraceptive used by the spouse/partner of male subject. 18. Within the last 2 years before screening or during the screening period, have a history of alcohol or drug abuse, or have tested positive for drug use during the screening period (Note: Subjects who have used drugs for the purpose of chronic pain treatment, have documented records of medical history and concomitant medications, may, at the investigator's discretion and with the sponsor's approval, be eligible for inclusion as trial subjects). 19. Deemed unsuitable for participation in the clinical trial by the investigator due to reasons including clinical laboratory test results and other factors. 20. Participating in a non-interventional clinical study that may affect the safety or efficacy assessment of subjects in this clinical trial.

Treatments Being Tested

DRUG

Vutiglabridin

Once-daily oral administration

DRUG

Placebo

Once-daily oral administration

Locations (9)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hallym University Medical Center
Anyang-si, Gyeonggi-do, South Korea
The Catholic University of Korea Uijeongbu St.Marys Hostpial
Uijeongbu-si, Gyeonggi-do, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Inje University Sanggye Paik Hospital
Seoul, South Korea
KyungHee University Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06329141), the sponsor (Glaceum), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06329141 clinical trial studying?

1. Study Objective \- To assess the efficacy and safety of vutiglabridin in early Parkindson's disease 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 early Parkinson's disease 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 b… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06329141?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06329141?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06329141. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06329141. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.