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Clinical Trials in South Korea / NCT07390552
Recruiting Phase 2

A Study of PLH-2301 in Subjects With Sarcopenia

NCT07390552 · tracked via the Priya Life Science South Korea tracker
Sponsor
Pluto Inc
Phase
Phase 2
Started
2026-05-08
Last updated
2026-05-12

Condition(s) studied

Sarcopenia in Elderly

Investigational drug(s) / intervention(s)

PLH-2301Placebo

PLH-2301: PLH-2301 administered orally according to assigned dosing regimen.

Placebo: Matching placebo administered orally according to assigned dosing regimen.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female subjects aged 65 years or older at the time of consent * Diagnosis of sarcopenia based on predefined diagnostic criteria * Short Physical Performance Battery (SPPB) total score within the protocol-defined range at screening * Stable body weight for at least 3 months prior to screening * Able to walk independently with or without assistive devices * Willing and able to comply with study procedures * Provided written informed consent prior to any study-specific procedures Exclusion Criteria: * History of clinically significant neuromuscular or musculoskeletal disorders that could affect muscle function * Uncontrolled cardiovascular, hepatic, renal, or metabolic disease * Use of medications known to affect muscle mass or function within the protocol-defined washout period * Participation in another interventional clinical trial within 3 months prior to screening * Any medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation

Primary outcome measure(s)

  • Change from baseline in Short Physical Performance Battery (SPPB) total score — Baseline to Week 12
    Change from baseline in the Short Physical Performance Battery (SPPB) total score. The Short Physical Performance Battery is a composite measure of lower extremity function with total scores ranging from 0 to 12, where higher scores indicate better physical performance.

Trial sites (5)

FacilityCityRegionStatus
Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do Recruiting
The Catholic University of Korea, St. Vincent's Hospital Suwon Gyeonggi-do Recruiting
Korea University Anam Hospital Seoul Seoul Recruiting
Seoul St. Mary's Hospital Seoul Seoul Recruiting
Korea University Guro Hospital Seoul Seoul Recruiting

Other trials for the same condition

Relationship Between Swallowing Dynamics and Suprahyoid Muscle Activity in Sarcopenic Dysphagia Recruiting
A Study of AMC6156 in People With Sarcopenia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07390552 on ClinicalTrials.gov ↗ ← All trials in South Korea