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A Study of PLH-2301 in Subjects With Sarcopenia
Sponsor: Pluto Inc.
Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia. Eligible subjects aged 65 years and older will be randomized to receive placebo or one of three dose levels of PLH-2301 once daily for 12 weeks. The primary objective is to assess the effect of PLH-2301 on physical function compared with placebo.
Official title: A Prospective, Randomized, Double-blinded, Placebo-controlled, 4-Parallel Arm, Multi-center, Phase 2 Trial to Evaluate Efficacy and Safety of Orally Administered PLH-2301 in Elderly Patients With Sarcopenia
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
168
Start Date
2026-02-23
Completion Date
2027-06-30
Last Updated
2026-02-06
Healthy Volunteers
No
Conditions
Interventions
PLH-2301
PLH-2301 administered orally according to assigned dosing regimen.
Placebo
Matching placebo administered orally according to assigned dosing regimen.
Locations (3)
Korea University Anam Hospital
Seoul, Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, Seoul, South Korea
Korea University Guro Hospital
Seoul, Seoul, South Korea