A Study of AMC6156 in People With Sarcopenia

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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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