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

Summary

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.

Conditions

• Parkinson Disease

Interventions

DRUG

Vutiglabridin

Once-daily oral administration

DRUG

Placebo

Once-daily oral administration

Sponsors & Collaborators

• Kyunghee University Medical Center

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Inje University

  collaborator OTHER

• Hallym University Medical Center

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Uijeongbu St. Mary Hospital

  collaborator OTHER

• Glaceum

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-22

Primary Completion

2025-12-16

Completion

2026-01-07

Countries

• South Korea

Study Locations