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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

2026-05-08

Completion Date

2027-06-30

Last Updated

2026-05-12

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 (5)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

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