NCT07390552

A Study of PLH-2301 in Subjects With Sarcopenia

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Pluto Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Sarcopenia in Elderly

Interventions

Type	Name	Description
DRUG	PLH-2301	PLH-2301 administered orally according to assigned dosing regimen.
DRUG	Placebo	Matching placebo administered orally according to assigned dosing regimen.

Timeline

• Start date: 2026-02-23
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2026-02-05
• Last updated: 2026-02-06

Locations

3 sites across 1 country: South Korea