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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMC6156 0.1mg Treatment Group | Experimental |
| |
| AMC6156 0.3mg Treatment Group | Experimental |
| |
| AMC6156 1.0mg Treatment Group | Experimental |
| |
| Placebo Control Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMC6156 0.1mg | Drug | Oral administration of AMC6156 in tablet form at a dose of 0.1 mg once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Score from Baseline to Week 12 | At Visit 1 (Screening), Visit 2 (Week 0, Baseline), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Score at Week 4 and Week 8 | 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 | At Visit 2 (Week 0), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jooyeon Kim | Contact | +82-70-4105-6414 | yeoooonee@animuscure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Recruiting | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| AMC6156 0.3mg | Drug | Oral administration of AMC6156 in tablet form at a dose of 0.3 mg once daily for 12 weeks. |
|
| AMC6156 1.0mg | Drug | Oral administration of AMC6156 in tablet form at a dose of 1.0 mg once daily for 12 weeks. |
|
| Placebo | Drug | Oral administration of placebo tablets matching AMC6156 in appearance, once daily for 12 weeks. |
|
| Change in Appendicular Skeletal Muscle Mass (ASM) Measured by DXA | At Visit 1 (Screening) and Visit 5 (Week 12) |
| Change in Handgrip Strength | 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 | At Visit 2 (Week 0) and Visit 5 (Week 12) |
| Change in Sarcopenia Quality of Life (SarQoL) Score | At Visit 2 (Week 0) and Visit 5 (Week 12) |
| Seoul National University Bundang Hospital | Not yet recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
|
| Ajou University Hospital | Recruiting | Suwon | Gyeonggi-do | 16499 | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | Seoul | 03080 | South Korea |
|
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |