Study of Efficacy and Safety of AVTR101 in Sarcopenic Elderly

Aventi Biotechnology Inc.

Status and phase

Terminated

Phase 2

Conditions

Sarcopenia

Treatments

Drug: Placebo

Drug: AVTR101

Study type

Interventional

Funder types

Other

Industry

Identifiers

AV-R101-211

Details and patient eligibility

About

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

Enrollment

100 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.