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

Study Overview

• Status: Terminated
• Conditions: Sarcopenia
• Intervention / Treatment: Drug: AVTR101; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 07061
    • SMG-SNU Boramae Medical Center
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Subjects will take one 120 mg capsule (test drug) three times daily for a total treatment duration of 12 weeks.	Drug: AVTR101; three times daily
Placebo Comparator: Placebo Arm; Subjects will take one placebo capsule three times daily for a total treatment duration of 12 weeks.	Drug: Placebo; three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Aventi Biotechnology Inc.
• Collaborators: Asan Medical Center; Seoul National University Bundang Hospital; Ajou University School of Medicine; SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): June 14, 2024
• Study Completion (Actual): September 19, 2024

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Sarcopenia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: AV-R101-211

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No