Study of Efficacy and Safety of AVTR101 in Sarcopenic Elderly

Phase 2

Terminated

• Conditions: Sarcopenia
• Interventions: Drug: Placebo; Drug: AVTR101

• Registration Number: NCT06788236
• Lead Sponsor: Aventi Biotechnology Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-23
• Primary Completion: 2024-06-14
• Study Completion: 2024-09-19
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2025-01-16
• Study First Posted: 2025-01-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	Subjects will take one placebo capsule three times daily for a total treatment duration of 12 weeks.
Treatment Arm	AVTR101	Subjects will take one 120 mg capsule (test drug) three times daily for a total treatment duration of 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in SPPB total score at 12 weeks	From enrollment to the end of treatment 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.

Secondary Outcome Measures

Name	Time	Method
Change in SPPB total score at 4, 8 weeks	From enrollment to the end of treatment 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.
Change in 5-STS time	From enrollment to the end of treatment at 4, 8, 12 weeks	Change in 5-STS time required at 4, 8, 12 weeks after administration compared to baseline
Change in 6m walk speed	From enrollment to the end of treatment at 4, 8, 12 weeks	Change in 6m walk speed at 4, 8, 12 weeks after administration compared to baseline
Change in ASM measured by DXA	From enrollment to the end of treatment at 12 weeks	Change in ASM measured by DXA at 12 weeks after administration compared to baseline
Change in handgrip strength	From enrollment to the end of treatment at 4, 8, 12 weeks	Change in handgrip strength at 4, 8, 12 weeks after administration compared to baseline
Change in SARC-F total score	From enrollment to the end of treatment at 12 weeks	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.
Change in SarQoL: total score	From enrollment to the end of treatment at 12 weeks	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.

Trial Locations

Locations (4)

Ajou University School of Medicine; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of