Phase 2 Study of Oral PLH-2301 for Treating Sarcopenia in Adults 65 and Older Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Physical Function and Safety

What this Trial Is About

Sarcopenia is a progressive muscle disorder that leads to loss of muscle strength, physical performance, and quality of life in older adults. This Phase 2 randomized, double-blind, placebo-controlled study aims to evaluate the effectiveness and safety of PLH-2301 in people aged 65 years and older who have sarcopenia. The main goal is to assess how PLH-2301 affects physical function compared with a placebo. Participants will be randomly assigned to one of four groups a placebo group or one of three groups receiving different doses of PLH-2301 200 mg, 400 mg, or 600 mg. The study treatments are taken orally once daily for 12 weeks. Each group follows a specific dosing schedule involving morning, afternoon, and evening doses, with some receiving placebo during certain times to maintain blinding. During the study, participants will undergo assessments of physical function, including the Short Physical Performance Battery SPPB, gait speed, chair stand test, handgrip strength, muscle mass, and quality of life related to sarcopenia. Safety is monitored through adverse event tracking, laboratory tests, vital signs, and physical exams. The full study duration is 12 weeks of treatment with ongoing monitoring throughout.

A Study of PLH-2301 in Subjects With Sarcopenia