A Study of PLH-2301 in Subjects With Sarcopenia (PLH-2301_P2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia in Elderly
• Intervention / Treatment: Drug: Placebo; Drug: PLH-2301

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.

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: CRO PM; Phone Number: +82-70-4335-4755; Email: mskim1@symyoo.com

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Clinical Research Coordinator; Phone Number: +82-10-8140-8670; Email: seungahyu0101@gmail.com
    • Suwon, Gyeonggi-do, South Korea
      • Recruiting
      • The Catholic University of Korea, St. Vincent'S Hospital
      • Contact: Clinical Research Coordinator; Phone Number: +82-10-4274-6399; Email: nanjingmei@kakao.com
  • Seoul
    • Seoul, Seoul, South Korea, 08308
      • Recruiting
      • Korea University Guro Hospital
      • Contact: Clinical Research Coordinator; Phone Number: +82-10-5445-6587; Email: grkmcgrfm001@kumc.or.kr
    • Seoul, Seoul, South Korea, 02841
      • Recruiting
      • Korea University Anam Hospital
      • Contact: Clinical Research Coordinator; Phone Number: +82-10-4981-6641; Email: sy92675@naver.com
    • Seoul, Seoul, South Korea, 06591
      • Recruiting
      • Seoul St. Mary'S Hospital
      • Contact: Clinical Research Coordinator; Phone Number: +82-10-3370-2206; Email: t33702206@cmcnu.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects receive placebo orally in the morning, afternoon, and evening for 12 weeks.	Drug: Placebo; Matching placebo administered orally according to assigned dosing regimen.
Experimental: PLH-2301 200mg; Subjects receive PLH-2301 in the morning and placebo in the afternoon and evening for 12 weeks.	Drug: Placebo; Matching placebo administered orally according to assigned dosing regimen.; Drug: PLH-2301; PLH-2301 administered orally according to assigned dosing regimen.
Experimental: PLH-2301 400mg; Subjects receive PLH-2301 in the morning and evening and placebo in the afternoon for 12 weeks.	Drug: Placebo; Matching placebo administered orally according to assigned dosing regimen.; Drug: PLH-2301; PLH-2301 administered orally according to assigned dosing regimen.
Experimental: PLH-2301 600mg; Subjects receive PLH-2301 in the morning, afternoon, and evening for 12 weeks.	Drug: PLH-2301; PLH-2301 administered orally according to assigned dosing regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Short Physical Performance Battery (SPPB) total score	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.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in gait speed	Change from baseline in chair stand test time as a component of physical performance	Baseline to Week 12
Change from baseline in chair stand test time	Change from baseline in chair stand test time as a component of physical performance	Baseline to Week 12
Change from baseline in handgrip strength	Change from baseline in handgrip strength measured using a dynamometer	Baseline to Week 12
Change from baseline in appendicular skeletal muscle mass	Change from baseline in appendicular skeletal muscle mass measured by bioelectrical impedance analysis	Baseline to Week 12
Change from baseline in Sarcopenia Quality of Life (SarQoL-K) total score	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.	Baseline to Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment compliance rate	Compliance with study medication, dietary intervention, and exercise program was monitored throughout the study.	Throughout the 12-week treatment period

Collaborators and Investigators

• Sponsor: Pluto Inc.
• Collaborators: Symyoo
• Investigators: Study Director: Sun Ahe Lee, Pluto Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Sarcopenia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sarcopenia
• Other Study ID Numbers: PLH-2301_P2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No