PLH-2301 for sarcopenia in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, randomized, double-blind, placebo-controlled trial will enroll about 168 adults aged 65 or older with sarcopenia and randomize them 1:1:1:1 to placebo or PLH-2301 at 200 mg, 400 mg, or 600 mg once daily for 12 weeks. The primary outcome is change from baseline in the Short Physical Performance Battery (SPPB) total score at Week 12, and secondary outcomes include gait speed, chair stand performance, handgrip strength, appendicular skeletal muscle mass, and health-related quality of life. Safety will be monitored throughout the study with adverse event reporting, laboratory tests, vital signs, and physical examinations. The trial is conducted at multiple academic hospitals in Seoul and Gyeonggi-do, South Korea.

Why it matters

Who can join: the full rules

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

Where it's running

• Seoul National University Bundang Hospital
  Seongnam-si, Gyeonggi-do, South Korea Recruiting
• The Catholic University of Korea, St. Vincent's Hospital
  Suwon, Gyeonggi-do, South Korea Recruiting
• Korea University Anam Hospital
  Seoul, Seoul, South Korea Recruiting
• Seoul St. Mary's Hospital
  Seoul, Seoul, South Korea Recruiting
• Korea University Guro Hospital
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Cro Pm
• Email: mskim1@symyoo.com
• Phone: +82-70-4335-4755

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.