Actively Recruiting
A Study of PLH-2301 in Subjects With Sarcopenia
Led by Pluto Inc. · Updated on 2026-05-12
168
Participants Needed
5
Research Sites
59 weeks
Total Duration
On this page
Sponsors
P
Pluto Inc.
Lead Sponsor
S
Symyoo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official 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, in the investigator's opinion, would interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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