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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Oral administration of AMC6156 in tablet form at a dose of 0.1 mg once daily for 12 weeks.
Oral administration of AMC6156 in tablet form at a dose of 0.3 mg once daily for 12 weeks.
Oral administration of AMC6156 in tablet form at a dose of 1.0 mg once daily for 12 weeks.
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
NOT_YET_RECRUITINGAjou University Hospital
Suwon, Gyeonggi-do, South Korea
RECRUITINGChange in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12
Time frame: At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12)
Change in Short Physical Performance Battery (SPPB) Score at Week 4 and Week 8
Time frame: 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
Time frame: 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
Time frame: At Visit 1 (Screening) and Visit 5 (Week 12)
Change in Handgrip Strength
Time frame: 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
Time frame: At Visit 2 (Week 0) and Visit 5 (Week 12)
Change in Sarcopenia Quality of Life (SarQoL) Score
Time frame: At Visit 2 (Week 0) and Visit 5 (Week 12)
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Oral administration of placebo tablets matching AMC6156 in appearance, once daily for 12 weeks.
Seoul National University Hospital
Seoul, Seoul, South Korea
RECRUITING