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NCT Number: NCT07390552

A Study of PLH-2301 in Subjects With Sarcopenia

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.

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Key information

Conditions

Sarcopenia in Elderly Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PLH-2301

Drug

PLH-2301 administered orally according to assigned dosing regimen.

Placebo

Drug

Matching placebo administered orally according to assigned dosing regimen.

Primary outcomes

  1. Change from baseline in Short Physical Performance Battery (SPPB) total score

    Time frame: 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.

Secondary outcomes

  1. Change from baseline in gait speed

    Time frame: Baseline to Week 12

    Change from baseline in chair stand test time as a component of physical performance

  2. Change from baseline in chair stand test time

    Time frame: Baseline to Week 12

    Change from baseline in chair stand test time as a component of physical performance

  3. Change from baseline in handgrip strength

    Time frame: Baseline to Week 12

    Change from baseline in handgrip strength measured using a dynamometer

  4. Change from baseline in appendicular skeletal muscle mass

    Time frame: Baseline to Week 12

    Change from baseline in appendicular skeletal muscle mass measured by bioelectrical impedance analysis

  5. Change from baseline in Sarcopenia Quality of Life (SarQoL-K) total score

    Time frame: Baseline to Week 12

    Change from baseline in the Sarcopenia Quality of Life questionnaire (SarQoL-K) total score.

    The SarQoL-K total score ranges from 0 to 100, with higher scores indicating better quality of life.

Other outcomes

  1. Treatment compliance rate

    Time frame: Throughout the 12-week treatment period

    Compliance with study medication, dietary intervention, and exercise program was monitored throughout the study.

Study contacts

Contact information is provided by the study sponsor or research team.

CRO PM

CONTACT

[email protected]

+82-70-4335-4755

Sponsors and collaborators

Lead sponsor

Pluto Inc.

Industry

Collaborators

  • Symyoo

Registry information

Official study 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

Acronym: PLH-2301_P2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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