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Due subject enrollment delay and to secure expiration of the test drug, it was necessary to minimize the subject enrollment period. In addition, it was deemed advantageous to increase the overall efficiency of the clinical program.
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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Ajou University School of Medicine | OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
| Asan Medical Center |
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The goal of this clinical trial is to primarily evaluate the efficacy of AVTR101 to placebo on physical performance in sarcopenia patients.
Participants will:
Take AVTR101 or a placebo three times daily for 12 weeks Visit the clinic once every 4 weeks for checkups and tests
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Subjects will take one 120 mg capsule (test drug) three times daily for a total treatment duration of 12 weeks. |
|
| Placebo Arm | Placebo Comparator | Subjects will take one placebo capsule three times daily for a total treatment duration of 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVTR101 | Drug | three times daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SPPB total score at 12 weeks | The SPPB evaluates lower extremity function through three components: standing balance, usual gait speed, and chair stand. Each component is scored on a scale from 0 to 4, with the total score ranging from 0 to 12. A higher score reflects a higher level of function. | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SPPB total score at 4, 8 weeks | The SPPB evaluates lower extremity function through three components: standing balance, usual gait speed, and chair stand. Each component is scored on a scale from 0 to 4, with the total score ranging from 0 to 12. A higher score reflects a higher level of function. | From enrollment to the end of treatment at 4, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hematology: RBC | Laboratory test - hematology, Red Blood Cell (10^6/uL) | 0, 4, 8, 12 week |
| Hematology: Hemoglobin | Laboratory test - hematology, Hemoglobin (g/dL) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea | ||
| Ajou University School of Medicine |
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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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| OTHER |
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| Drug |
three times daily |
|
| Change in 5-STS time | Change in 5-STS time required at 4, 8, 12 weeks after administration compared to baseline | From enrollment to the end of treatment at 4, 8, 12 weeks |
| Change in 6m walk speed | Change in 6m walk speed at 4, 8, 12 weeks after administration compared to baseline | From enrollment to the end of treatment at 4, 8, 12 weeks |
| Change in ASM measured by DXA | Change in ASM measured by DXA at 12 weeks after administration compared to baseline | From enrollment to the end of treatment at 12 weeks |
| Change in handgrip strength | Change in handgrip strength at 4, 8, 12 weeks after administration compared to baseline | From enrollment to the end of treatment at 4, 8, 12 weeks |
| Change in SARC-F total score | The SARC-F is a simple, 5-item screening questionnaire designed to rapidly assess the risk of sarcopenia in older adults. It evaluates five components: Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls. Each item is scored from 0 to 2, resulting in a total score ranging from 0 to 10, with a score of 4 or higher indicating an increased risk of sarcopenia. | From enrollment to the end of treatment at 12 weeks |
| Change in SarQoL: total score | The SarQoL (Sarcopenia and Quality of Life) is a validated, sarcopenia-specific quality of life questionnaire designed for older adults. It consists of 22 questions across seven domains: physical and mental health, locomotion, body composition, functionality, activities of daily living, leisure activities, and fears. The questionnaire produces a total score ranging from 0 to 100, with higher scores indicating better quality of life. | From enrollment to the end of treatment at 12 weeks |
| 0, 4, 8, 12 week |
| Hematology: Hematocrit | Laboratory test - hematology, Hematocrit (%) | 0, 4, 8, 12 week |
| Blood chemistry test: Ca | Laboratory tests - Blood chemistry test, Ca (mg/dL) | 0, 4, 8, 12 week |
| Blood chemistry test: ALT | Laboratory tests - Blood chemistry test, ALT (U/L) | 0, 4, 8, 12 week |
| Blood chemistry test: AST | Laboratory tests - Blood chemistry test, AST (U/L) | 0, 4, 8, 12 week |
| Blood chemistry test: ALP | Laboratory tests - Blood chemistry test, ALP (U/L) | 0, 4, 8, 12 week |
| Blood chemistry test: Total bilirubin (mg/dL) | Laboratory tests - Blood chemistry test, Total bilirubin (mg/dL) | 0, 4, 8, 12 week |
| Blood chemistry test: γ-GT | Laboratory tests - Blood chemistry test, γ-GT (U/L) | 0, 4, 8, 12 week |
| Blood chemistry test: Lactic Dehydrogenase | Laboratory tests - Blood chemistry test, Lactic Dehydrogenase (U/L) | 0, 4, 8, 12 week |
| Blood chemistry test: Total Cholesterol | Laboratory tests - Blood chemistry test, Total Cholesterol (mg/dL) | 0, 4, 8, 12 week |
| Urinalysis: Leukocyte | Laboratory tests - Urinalysis, Leukocyte (10^2/uL) | 0, 4, 8, 12 week |
| Urinalysis: Nitrate | Laboratory tests - Urinalysis, Nitrate (mg/dL) | 0, 4, 8, 12 week |
| Electrocardiogram: date and time | 12-lead ECG (Electrocardiogram) - date and time of ECG | 0, 4, 8, 12 week |
| Electrocardiogram: heart rate | 12-lead ECG (Electrocardiogram) - heart rate (beat per minute, bpm) | 0, 4, 8, 12 week |
| Electrocardiogram: PR interval | 12-lead ECG (Electrocardiogram) - PR interval (millisecond, ms) | 0, 4, 8, 12 week |
| Electrocardiogram: QT interval uncorrected | 12-lead ECG (Electrocardiogram) - QT interval uncorrected (millisecond, ms) | 0, 4, 8, 12 week |
| Electrocardiogram: QTc interval | 12-lead ECG (Electrocardiogram) - QTc interval (millisecond, ms) | 0, 4, 8, 12 week |
| Electrocardiogram: QRS duration | 12-lead ECG (Electrocardiogram) - QRS duration (millisecond, ms) | 0, 4, 8, 12 week |
| Suwon |
| Gyeonggi-do |
| 16499 |
| South Korea |
| Asan Medical Center | Seoul | Seoul | 05505 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | Seoul | 07061 | South Korea |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |