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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IN-207907 120 mg | Experimental |
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| IN-207907 240 mg | Experimental |
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| IN-207907 360 mg | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN-207907 120 mg | Drug | IN-207907 120 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Short Physical Performance Battery (SPPB) total score | Range 0-12, higher scores indicate better physical performance | From baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Short Physical Performance Battery (SPPB) total score | Range 0-12, higher scores indicate better physical performance | From baseline to week 4 and 8 |
| Change in time to complete the 4-Meter Walk Test (4MWT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yujin Choi | Contact | +82 31-5176-4668 | yujin.choi@inno-n.com | |
| Ahrong Kim | Contact | +82 31-5176-4666 | ahrong.kim@inno-n.com |
| Name | Affiliation | Role |
|---|---|---|
| Jae-Young Lim | Seoul National University Bundang Hospital | Principal Investigator |
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| IN-207907 240 mg | Drug | IN-207907 240 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses. |
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| IN-207907 360 mg | Drug | IN-207907 360 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses. |
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| Placebo | Drug | Placebo will be administered by intravenous injection at 4-week intervals for a total of 3 doses. |
|
Measured in seconds, lower values indicate better performance
| 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 | 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 | 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 | From baseline to week 4, 8 and 12 |
| Change in Appendicular Skeletal muscle Mass (ASM) as measured by Dual-energy X-ray Absorptiometry (DEXA) | 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 | Range 0-10; higher scores indicate worse sarcopenia risk | 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 | From baseline to week 12 |
| Change in proportion of FoxP3+ regulatory T cells | Measured as % | From baseline to week 4, 8 and 12 |
| Change in serum interleukin-6 (IL-6) concentration | Measured in pg/mL | From baseline to week 4, 8 and 12 |
| Change in serum insulin-like growth factor-1 (IGF-1) concentration | Measured in ng/mL | From baseline to week 4, 8 and 12 |
| Change in high-sensitivity C-reactive protein (hs-CRP) level | Measured in mg/L | From baseline to week 4, 8 and 12 |
| Exercise and dietary compliance rate | From baseline to week 4, 8 and 12 |