A Study of PLH-2301 in Subjects With Sarcopenia

Sarcopenia is a progressive and generalized skeletal muscle disorder associated with loss of muscle strength, physical performance, and quality of life in older adults. Currently, there are limited approved pharmacological treatment options for sarcopenia. This Phase 2 study is designed to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia. Approximately 168 eligible subjects will be randomized in a 1:1:1:1 ratio to receive placebo or PLH-2301 at dose levels of 200 mg, 400 mg, or 600 mg administered orally once daily for 12 weeks. The primary efficacy endpoint is the change from baseline in the Short Physical Performance Battery (SPPB) total score at Week 12. Secondary endpoints include changes in gait speed, chair stand performance, handgrip strength, appendicular skeletal muscle mass, and health-related quality of life. Safety will be assessed throughout the study by monitoring adverse events, laboratory tests, vital signs, and physical examinations.