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NOT YET RECRUITING
NCT07390552
PHASE2

A Study of PLH-2301 in Subjects With Sarcopenia

Sponsor: Pluto Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

PLH-2301

PLH-2301 administered orally according to assigned dosing regimen.

DRUG

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