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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University School of Medicine
Suwon, Gyeonggi-do, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoul, South Korea
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.
Time frame: From enrollment to the end of treatment at 12 weeks
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.
Time frame: From enrollment to the end of treatment at 4, 8 weeks
Change in 5-STS time
Change in 5-STS time required at 4, 8, 12 weeks after administration compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment at 4, 8, 12 weeks
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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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 12 weeks