Actively Recruiting
A Prospective, Randomized, Double-blinded, Placebo-controlled, Multi-center Phase 2 Trial to Evaluate PLH-2301 in Elderly Patients With Sarcopenia
Led by Pluto Inc. · Updated on 2026-05-12
168
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Pluto Inc.
Lead Sponsor
S
Symyoo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sarcopenia is a progressive muscle disorder that leads to loss of muscle strength, physical performance, and quality of life in older adults. This Phase 2 randomized, double-blind, placebo-controlled study aims to evaluate the effectiveness and safety of PLH-2301 in people aged 65 years and older who have sarcopenia. The main goal is to assess how PLH-2301 affects physical function compared with a placebo. Participants will be randomly assigned to one of four groups: a placebo group or one of three groups receiving different doses of PLH-2301 (200 mg, 400 mg, or 600 mg). The study treatments are taken orally once daily for 12 weeks. Each group follows a specific dosing schedule involving morning, afternoon, and evening doses, with some receiving placebo during certain times to maintain blinding. During the study, participants will undergo assessments of physical function, including the Short Physical Performance Battery (SPPB), gait speed, chair stand test, handgrip strength, muscle mass, and quality of life related to sarcopenia. Safety is monitored through adverse event tracking, laboratory tests, vital signs, and physical exams. The full study duration is 12 weeks of treatment with ongoing monitoring throughout.
CONDITIONS
Brief Title
A Study of PLH-2301 in Subjects With Sarcopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 would interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive PLH-2301 or placebo orally once daily for 12 weeks to evaluate its effect on muscle strength and physical performance.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 5 locations
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Actively Recruiting
2
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Actively Recruiting
3
Korea University Anam Hospital
Seoul, Seoul, South Korea, 02841
Actively Recruiting
4
Seoul St. Mary's Hospital
Seoul, Seoul, South Korea, 06591
Actively Recruiting
5
Korea University Guro Hospital
Seoul, Seoul, South Korea, 08308
Actively Recruiting
Research Team
C
CRO PM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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