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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 5
- 主要终点
- Change from baseline in Short Physical Performance Battery (SPPB) total score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
Subjects receive placebo orally in the morning, afternoon, and evening for 12 weeks.
干预措施: Placebo (Drug)
PLH-2301 200mg
Subjects receive PLH-2301 in the morning and placebo in the afternoon and evening for 12 weeks.
干预措施: PLH-2301 (Drug)
PLH-2301 400mg
Subjects receive PLH-2301 in the morning and evening and placebo in the afternoon for 12 weeks.
干预措施: PLH-2301 (Drug)
PLH-2301 400mg
Subjects receive PLH-2301 in the morning and evening and placebo in the afternoon for 12 weeks.
干预措施: Placebo (Drug)
PLH-2301 200mg
Subjects receive PLH-2301 in the morning and placebo in the afternoon and evening for 12 weeks.
干预措施: Placebo (Drug)
PLH-2301 600mg
Subjects receive PLH-2301 in the morning, afternoon, and evening for 12 weeks.
干预措施: PLH-2301 (Drug)
结局指标
主要结局
Change from baseline in Short Physical Performance Battery (SPPB) total score
时间窗: Baseline to Week 12
Change from baseline in the Short Physical Performance Battery (SPPB) total score. The Short Physical Performance Battery is a composite measure of lower extremity function with total scores ranging from 0 to 12, where higher scores indicate better physical performance.
次要结局
- Change from baseline in gait speed(Baseline to Week 12)
- Change from baseline in chair stand test time(Baseline to Week 12)
- Change from baseline in handgrip strength(Baseline to Week 12)
- Change from baseline in appendicular skeletal muscle mass(Baseline to Week 12)
- Change from baseline in Sarcopenia Quality of Life (SarQoL-K) total score(Baseline to Week 12)