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A Study of PLH-2301 in Subjects With Sarcopenia

NCT07390552 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-05-12

No results posted yet for this 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.

Conditions

  • Sarcopenia in Elderly

Interventions

DRUG

PLH-2301

PLH-2301 administered orally according to assigned dosing regimen.

DRUG

Placebo

Matching placebo administered orally according to assigned dosing regimen.

Sponsors & Collaborators

  • Symyoo

    collaborator INDUSTRY

  • Pluto Inc.

    lead INDUSTRY

Principal Investigators

  • Sun Ahe Lee · Pluto Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-08
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07390552 on ClinicalTrials.gov