Clinical trial NCT06788236: Study of Efficacy and Safety of AVTR101 in Sarcopenic Elderly
Official title: A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of AVTR101 in Sarcopenia Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sarcopenia
Keywords: Sarcopenia
Lead sponsor: Aventi Biotechnology Inc.
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Bundang Hospital
name: Ajou University School of Medicine
name: SMG-SNU Boramae Medical Center
name: Asan Medical Center
First posted: 2025-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change in SPPB total score at 12 weeks
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Change in SPPB total score at 4, 8 weeks
timeFrame: From enrollment to the end of treatment at 4, 8 weeks
measure: Change in 5-STS time
timeFrame: From enrollment to the end of treatment at 4, 8, 12 weeks
measure: Change in 6m walk speed
timeFrame: From enrollment to the end of treatment at 4, 8, 12 weeks
measure: Change in ASM measured by DXA
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Change in handgrip strength
timeFrame: From enrollment to the end of treatment at 4, 8, 12 weeks
measure: Change in SARC-F total score
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Change in SarQoL: total score
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
measure: Hematology: RBC
timeFrame: 0, 4, 8, 12 week
measure: Hematology: Hemoglobin
timeFrame: 0, 4, 8, 12 week
measure: Hematology: Hematocrit
timeFrame: 0, 4, 8, 12 week
measure: Blood chemistry test: Ca
timeFrame: 0, 4, 8, 12 week
measure: Blood chemistry test: ALT
timeFrame: 0, 4, 8, 12 week
measure: Blood chemistry test: AST
timeFrame: 0, 4, 8, 12 week
measure: Blood chemistry test: ALP
timeFrame: 0, 4, 8, 12 week
measure: Blood chemistry test: Total bilirubin (mg/dL)
timeFrame: 0, 4, 8, 12 week
measure: Blood chemistry test: γ-GT
timeFrame: 0, 4, 8, 12 week
measure: Blood chemistry test: Lactic Dehydrogenase
timeFrame: 0, 4, 8, 12 week
measure: Blood chemistry test: Total Cholesterol
timeFrame: 0, 4, 8, 12 week
measure: Urinalysis: Leukocyte
timeFrame: 0, 4, 8, 12 week
measure: Urinalysis: Nitrate
timeFrame: 0, 4, 8, 12 week
measure: Electrocardiogram: date and time
timeFrame: 0, 4, 8, 12 week
measure: Electrocardiogram: heart rate
timeFrame: 0, 4, 8, 12 week
measure: Electrocardiogram: PR interval
timeFrame: 0, 4, 8, 12 week
measure: Electrocardiogram: QT interval uncorrected
timeFrame: 0, 4, 8, 12 week
measure: Electrocardiogram: QTc interval
timeFrame: 0, 4, 8, 12 week
measure: Electrocardiogram: QRS duration
timeFrame: 0, 4, 8, 12 week
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References: