NCT07072195招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AMC6156 in Patients With Sarcopenia
Animuscure Inc.4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12
研究概览
简要总结
This clinical trial aims to find out whether AMC6156 can improve physical function and is safe in older adults with sarcopenia. Participants will take AMC6156 or a placebo daily for 12 weeks, and their movement, strength, and safety will be regularly monitored through tests and checkups.
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
- •Voluntary participation with written informed consent
- •Male ≥ 65 years or postmenopausal female
- •Diagnosed with sarcopenia:
- •ASM < 7.0 kg/m² (men) or < 5.4 kg/m² (women)
- •Plus low handgrip strength or SPPB ≤ 9
- •MNA screening score ≥ 8
- •Body weight ≥ 35 kg, BMI between 15-30 kg/m²
- •Willing and able to follow exercise and nutrition guidance
排除标准
- •Allergy to investigational drug
- •History of GI bleeding, ulcers, or severe liver/kidney/heart disease
- •QTc ≥ 450 ms with symptoms
- •Severe COPD, uncontrolled diabetes or thyroid disease
- •Diseases causing cachexia or muscle wasting (e.g., ALS, Parkinson's)
- •Vitamin D deficiency (<10 ng/mL), hemoglobin <10 g/dL
- •Severe psychiatric disorders or MMSE < 21
- •Inability to walk or recent fracture/surgery affecting mobility
- •Use of prohibited medications or recent participation in other clinical trials
- •Investigator deems the subject unsuitable for the study
研究组 & 干预措施
AMC6156 0.1mg Treatment Group
Experimental
干预措施: AMC6156 0.1mg (Drug)
AMC6156 0.3mg Treatment Group
Experimental
干预措施: AMC6156 0.3mg (Drug)
AMC6156 1.0mg Treatment Group
Experimental
干预措施: AMC6156 1.0mg (Drug)
Placebo Control Group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12
时间窗: At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)
次要结局
- Change in Short Physical Performance Battery (SPPB) Score at Week 4 and Week 8(At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12))
- Change in Timed Up and Go (TUG) Test Time(At Visit 2 (Week 0), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12))
- Change in Appendicular Skeletal Muscle Mass (ASM) Measured by DXA(At Visit 1 (Screening) and Visit 5 (Week 12))
- Change in Handgrip Strength(At Visit 1 (Screening), Visit 2 (Week 0) ,Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12))
- Change in SARC-F Score(At Visit 2 (Week 0) and Visit 5 (Week 12))
- Change in Sarcopenia Quality of Life (SarQoL) Score(At Visit 2 (Week 0) and Visit 5 (Week 12))
研究者
研究点 (4)
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