Study of Efficacy and Safety of AVTR101 in Sarcopenic Elderly

NCT06788236 | Terminated Phase 2

• 1 other identifier: AV-R101-211
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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

Conditions

Sarcopenia

Keywords

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in SPPB total score at 4, 8 weeks

  From enrollment to the end of treatment at 4, 8 weeks

• Change in 5-STS time

  From enrollment to the end of treatment at 4, 8, 12 weeks

• Change in 6m walk speed

  From enrollment to the end of treatment at 4, 8, 12 weeks

• Change in ASM measured by DXA

  From enrollment to the end of treatment at 12 weeks

• Change in handgrip strength

  From enrollment to the end of treatment at 4, 8, 12 weeks

Other Outcomes (19)

• Hematology: RBC

  0, 4, 8, 12 week

• Hematology: Hemoglobin

  0, 4, 8, 12 week

• Hematology: Hematocrit

  0, 4, 8, 12 week

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Subjects will take one 120 mg capsule (test drug) three times daily for a total treatment duration of 12 weeks.

Drug: AVTR101

Placebo Arm

PLACEBO COMPARATOR

Subjects will take one placebo capsule three times daily for a total treatment duration of 12 weeks.

Drug: Placebo

Interventions

AVTR101 DRUG

three times daily

Treatment Arm

Placebo DRUG

three times daily

Placebo Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Ajou University School of Medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, Seoul, 07061, South Korea

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 23, 2025
• Study Start: May 23, 2022
• Primary Completion: June 14, 2024
• Study Completion: September 19, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

KR (4)