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
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.
• Male or female subjects aged 65 years or older at the time of consent
• Diagnosis of sarcopenia based on predefined diagnostic criteria
• Short Physical Performance Battery (SPPB) total score within the protocol-defined range at screening
• Stable body weight for at least 3 months prior to screening
• Able to walk independently with or without assistive devices
• Willing and able to comply with study procedures
• Provided written informed consent prior to any study-specific procedures