A Study of PLH-2301 in Subjects With Sarcopenia

Официальное название

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

Обзор

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.

Подробное описание

Sarcopenia is a progressive and generalized skeletal muscle disorder associated with loss of muscle strength, physical performance, and quality of life in older adults. Currently, there are limited approved pharmacological treatment options for sarcopenia.

This Phase 2 study is designed to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia. Approximately 168 eligible subjects will be randomized in a 1:1:1:1 ratio to receive placebo or PLH-2301 at dose levels of 200 mg, 400 mg, or 600 mg administered orally once daily for 12 weeks.

The primary efficacy endpoint is the change from baseline in the Short Physical Performance Battery (SPPB) total score at Week 12. Secondary endpoints include changes in gait speed, chair stand performance, handgrip strength, appendicular skeletal muscle mass, and health-related quality of life. Safety will be assessed throughout the study by monitoring adverse events, laboratory tests, vital signs, and physical examinations.

Вмешательства

• Препарат PLH-2301
  PLH-2301 administered orally according to assigned dosing regimen.
• Препарат Placebo
  Matching placebo administered orally according to assigned dosing regimen.

Первичные конечные точки

• Change from baseline in Short Physical Performance Battery (SPPB) total score [Срок оценки: Baseline to Week 12]

Вторичные конечные точки (5)

• Change from baseline in gait speed [Срок оценки: Baseline to Week 12]
• Change from baseline in chair stand test time [Срок оценки: Baseline to Week 12]
• Change from baseline in handgrip strength [Срок оценки: Baseline to Week 12]
• Change from baseline in appendicular skeletal muscle mass [Срок оценки: Baseline to Week 12]
• Change from baseline in Sarcopenia Quality of Life (SarQoL-K) total score [Срок оценки: Baseline to Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

South Korea · 5 центров

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

Идентификаторы

NCT: NCT07390552 · PLH-2301_P2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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