Study of Efficacy and Safety of AVTR101 in Sarcopenic Elderly

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of AVTR101 in Sarcopenia Patients

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

Inclusion Criteria:

• Men and women aged 65 years or older at the time of screening
• Appendicular skeletal muscle mass (ASM) measured by dual-energy x-ray absorptiometry (DXA), men < 7.0 kg/m2, women < 5.4 kg/m2
• Handgrip strength, men < 28 kg, women < 18 kg or 5-times sit-to-stand ≥ 12 second or 6 meter walking speed < 1.0 m/s
• nutrition status confirmed by mini nutritional assessment (MNA) is higher than 8 at the time of screening
• body weight ≥ 35 kg and BMI is between 15~30 kg/m2 at the time of screening
• After fully understanding the written consent, which includes compliance with the requirements and restrictions listed in the trial protocol and describes the overall nature and purpose of the clinical trial, including potential risks and side effects, the subject (or representative) voluntarily A person who signed a written consent form as

Exclusion Criteria:

• Patients with neuromuscular or nervous system diseases (e.g. Parkinson's disease, Lou Gehrig's disease, stroke affecting lower extremity function, muscular dystrophy, epilepsy, multiple sclerosis, etc.