The goal of this clinical trial is to learn if intervention can treat sarcopenia in the elderly. Researchers will compare IN-207907 120 mg, 240 mg, 360 mg and placebo to see if SPPB score improves.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
IN-207907 120 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
IN-207907 240 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
IN-207907 360 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
Change in the Short Physical Performance Battery (SPPB) total score
Range 0-12, higher scores indicate better physical performance
Time frame: From baseline to week 12
Change in the Short Physical Performance Battery (SPPB) total score
Range 0-12, higher scores indicate better physical performance
Time frame: From baseline to week 4 and 8
Change in time to complete the 4-Meter Walk Test (4MWT)
Measured in seconds, lower values indicate better performance
Time frame: From baseline to week 4, 8 and 12
Change in time to complete the 5 Times Chair Stand Test
Measured in seconds, lower values indicate better performance
Time frame: From baseline to week 4, 8 and 12
Change in time to complete the Timed Up and Go (TUG) test
Measured in seconds, lower values indicate better performance
Time frame: From baseline to week 4, 8 and 12
Change in handgrip strength measured using a digital hand dynamometer
In kilograms, higher values indicate greater muscle strength
Time frame: From baseline to week 4, 8 and 12
Change in Appendicular Skeletal muscle Mass (ASM) as measured by Dual-energy X-ray Absorptiometry (DEXA)
Time frame: From baseline to week 12
Change in the total score of the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire
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Placebo will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
Range 0-10; higher scores indicate worse sarcopenia risk
Time frame: From baseline to week 12
Change in the total score of the Sarcopenia Quality of Life (SarQoL) questionnaire
Range 0-100, higher scores indicate better quality of life
Time frame: From baseline to week 12
Change in proportion of FoxP3+ regulatory T cells
Measured as %
Time frame: From baseline to week 4, 8 and 12
Change in serum interleukin-6 (IL-6) concentration
Measured in pg/mL
Time frame: From baseline to week 4, 8 and 12
Change in serum insulin-like growth factor-1 (IGF-1) concentration
Measured in ng/mL
Time frame: From baseline to week 4, 8 and 12
Change in high-sensitivity C-reactive protein (hs-CRP) level
Measured in mg/L
Time frame: From baseline to week 4, 8 and 12
Exercise and dietary compliance rate
Time frame: From baseline to week 4, 8 and 12