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A Study of PLH-2301 in Subjects With Sarcopenia

RecruitingPhase 2Ages 65 Years - anyAllPluto Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • PLH-2301
  • Placebo
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Where

5 sites
Seoul National University Bundang Hospital
Seongnam-si, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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