PLH-2301 for sarcopenia in older adults
A Prospective, Randomized, Double-blinded, Placebo-controlled, 4-Parallel Arm, Multi-center, Phase 2 Trial to Evaluate Efficacy and Safety of Orally Administered PLH-2301 in Elderly Patients With Sarcopenia
This study will try whether taking PLH-2301 once daily for 12 weeks improves physical function in people aged 65 and older with sarcopenia compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Pluto Inc. Industry-sponsored |
| Locations | 5 sites (Seongnam-si, Gyeonggi-do and 4 other locations) |
| Trial ID | NCT07390552 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults aged 65 or older with a clinical diagnosis of sarcopenia, an SPPB score within the protocol-defined range, stable weight, and the ability to comply with study procedures and visits.
Not a fit: Patients with significant neuromuscular or musculoskeletal disorders, uncontrolled cardiovascular/hepatic/renal/metabolic disease, recent use of medications that affect muscle, or inability to attend site visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, PLH-2301 could improve muscle strength and physical function in older adults with sarcopenia, helping them maintain independence and quality of life.
How similar studies have performed: Previous pharmacologic approaches for sarcopenia—such as myostatin inhibitors and selective androgen receptor modulators—have shown mixed or limited benefits, so effective drug treatments remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seongnam-si, Gyeonggi-do and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.