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

NCT06329141 | Recruiting Phase 2

• 1 other identifier: HSG4112-P2-03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 9

Brief Summary

1. 1.Study Objective
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 early Parkinson's disease 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 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in MDS-UPDRS Part III Subscore

  From baseline to Week 24

Secondary Outcomes (7)

• Change From Baseline in MDS-UPDRS Part III Subscore

  From baseline to Week 4, Week 12, Week 28

• Change From Baseline in MDS-UPDRS Part II + Part III

  From baseline to Week 4, Week 12, Week 28

• Change From Baseline in CGI-C score

  From baseline to Week 4, Week 12, Week 24

• Change From Baseline in K-NMSS score

  From baseline to Week 4, Week 24

• Change From Baseline in Modified Hoehn-Yahr stage

  From baseline to Week 4, Week 12, Week 24

Study Arms (3)

Vutiglabridin 400 mg Multiple Dose

EXPERIMENTAL

Multiple oral dosing of vutiglabridin 400 mg for 24 weeks

Drug: Vutiglabridin

Vutiglabridin 800 mg Multiple Dose

EXPERIMENTAL

Multiple oral dosing of vutiglabridin 800 mg for 24 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 400 mg Multiple Dose; Vutiglabridin 800 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:

• 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).
• Adult men and women between the ages of 40 and 75 at Screening.
• 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.
• Diagnosed with Parkinson's disease within the last 24 months.
• Hoehn-Yahr stage ≤ 2
• 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
• 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.

You may not qualify if:

• Clinically significant new illness, per Investigator judgment, in the 4 weeks before Screening and during the screening period.
• Global Deterioration Scale (GDS) ≥ 4 at Screening.
• Have clinically significant depression as indicated by a Korean Beck Depression Inventory II score (K-BDI-II) \> 18 at Screening.
• BMI less than 18.5 kg/m2 at Screening.
• 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).
• 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).

Sponsors & Collaborators

• Glaceum: lead
• The Catholic University of Korea: collaborator
• Kyunghee University Medical Center: collaborator
• Korea University Guro Hospital: collaborator
• Samsung Medical Center: collaborator
• Severance Hospital: collaborator
• Inje University: collaborator
• Hallym University Medical Center: collaborator
• The Catholic University of Korea Uijeongbu St.Marys Hostpial: collaborator

Study Sites (9)

Hallym University Medical Center

Anyang-si, Gyeonggi-do, 14068, South Korea

RECRUITING

The Catholic University of Korea Uijeongbu St.Marys Hostpial

Uijeongbu-si, Gyeonggi-do, 11765, South Korea

RECRUITING

Inje University Busan Paik Hospital

Busan, 47392, South Korea

RECRUITING

Inje University Sanggye Paik Hospital

Seoul, 01757, South Korea

RECRUITING

KyungHee University Medical Center

Seoul, 02447, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

The Catholic University of Korea

Seoul, 06591, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Sohee Loh

CONTACT

82-31-8002-2561; shloh@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: March 18, 2024
• First Posted: March 25, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9)