A Study of PLH-2301 in Subjects With Sarcopenia

NCT07390552 | Not Yet Recruiting Phase 2

• 1 other identifier: PLH-2301_P2
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline in gait speed

  Baseline to Week 12

• Change from baseline in chair stand test time

  Baseline to Week 12

• Change from baseline in handgrip strength

  Baseline to Week 12

• Change from baseline in appendicular skeletal muscle mass

  Baseline to Week 12

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

  Baseline to Week 12

Other Outcomes (1)

• Treatment compliance rate

  Throughout the 12-week treatment period

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Subjects receive placebo orally in the morning, afternoon, and evening for 12 weeks.

Drug: Placebo

PLH-2301 200mg

EXPERIMENTAL

Subjects receive PLH-2301 in the morning and placebo in the afternoon and evening for 12 weeks.

Drug: PLH-2301; Drug: Placebo

PLH-2301 400mg

EXPERIMENTAL

Subjects receive PLH-2301 in the morning and evening and placebo in the afternoon for 12 weeks.

Drug: PLH-2301; Drug: Placebo

PLH-2301 600mg

EXPERIMENTAL

Subjects receive PLH-2301 in the morning, afternoon, and evening for 12 weeks.

Drug: PLH-2301

Interventions

PLH-2301 DRUG

PLH-2301 administered orally according to assigned dosing regimen.

PLH-2301 200mg; PLH-2301 400mg; PLH-2301 600mg

Placebo DRUG

Matching placebo administered orally according to assigned dosing regimen.

PLH-2301 200mg; PLH-2301 400mg; Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pluto Inc.: lead
• Symyoo: collaborator

Study Sites (3)

Korea University Anam Hospital

Seoul, Seoul, 02841, South Korea

Location

Seoul St. Mary's Hospital

Seoul, Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, Seoul, 08308, South Korea

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Sun Ahe Lee

  Pluto Inc.

  STUDY DIRECTOR

Central Study Contacts

CRO PM

CONTACT

+82-70-4335-4755; mskim1@symyoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 5, 2026
• Study Start: February 23, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)