NCT06845553

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Glaceum · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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 perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in Knee Osteoarthritis 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 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)

Interventions

Type	Name	Description
DRUG	Vutiglabridin	Once-daily oral administration
DRUG	Placebo	Once-daily oral administration

Timeline

• Start date: 2025-08-19
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2025-02-25
• Last updated: 2025-08-15

Locations

1 site across 1 country: South Korea