A Study of AMC6156 in People With Sarcopenia

Официальное название

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AMC6156 in Patients With Sarcopenia

Обзор

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.

Вмешательства

• Препарат AMC6156 0.1mg
  Oral administration of AMC6156 in tablet form at a dose of 0.1 mg once daily for 12 weeks.
• Препарат AMC6156 0.3mg
  Oral administration of AMC6156 in tablet form at a dose of 0.3 mg once daily for 12 weeks.
• Препарат AMC6156 1.0mg
  Oral administration of AMC6156 in tablet form at a dose of 1.0 mg once daily for 12 weeks.
• Препарат Placebo
  Oral administration of placebo tablets matching AMC6156 in appearance, once daily for 12 weeks.

Первичные конечные точки

• Change in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12 [Срок оценки: At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)]

Вторичные конечные точки (6)

• Change in Short Physical Performance Battery (SPPB) Score at Week 4 and Week 8 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At Visit 1 (Screening) and Visit 5 (Week 12)]
• Change in Handgrip Strength [Срок оценки: 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 [Срок оценки: At Visit 2 (Week 0) and Visit 5 (Week 12)]
• Change in Sarcopenia Quality of Life (SarQoL) Score [Срок оценки: At Visit 2 (Week 0) and Visit 5 (Week 12)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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 · 4 центра

• CHA Bundang Medical Center — Seongnam-si
• Seoul National University Bundang Hospital — Seongnam-si
• Ajou University Hospital — Suwon
• Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT07072195 · AMC6156_SP_P2A01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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