A Study of PLH-2301 in Subjects With Sarcopenia (NCT07390552) | Clinical Trial Compass
RecruitingPhase 2
A Study of PLH-2301 in Subjects With Sarcopenia
South Korea168 participantsStarted 2026-05-08
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Short Physical Performance Battery (SPPB) total score