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Recruiting NCT07390552

A Study of PLH-2301 in Subjects With Sarcopenia

Phase II Interventional Sarcopenia in Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PLH-2301, Placebo.
Who it may be relevant to
Registry conditions: Sarcopenia in Elderly. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug PLH-2301
    PLH-2301 administered orally according to assigned dosing regimen.
  • Drug Placebo
    Matching placebo administered orally according to assigned dosing regimen.

Primary outcome measures

  • Change from baseline in Short Physical Performance Battery (SPPB) total score [Time frame: Baseline to Week 12]
Secondary outcome measures (5)
  • Change from baseline in gait speed [Time frame: Baseline to Week 12]
  • Change from baseline in chair stand test time [Time frame: Baseline to Week 12]
  • Change from baseline in handgrip strength [Time frame: Baseline to Week 12]
  • Change from baseline in appendicular skeletal muscle mass [Time frame: Baseline to Week 12]
  • Change from baseline in Sarcopenia Quality of Life (SarQoL-K) total score [Time frame: Baseline to Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

South Korea · 5 centers
  • Seoul National University Bundang Hospital — Seongnam-si
  • The Catholic University of Korea, St. Vincent's Hospital — Suwon
  • Korea University Anam Hospital — Seoul
  • Seoul St. Mary's Hospital — Seoul
  • Korea University Guro Hospital — Seoul

Identifiers

NCT: NCT07390552 · PLH-2301_P2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗