Study of Efficacy and Safety of AVTR101 in Sarcopenic Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-23

Study Completion Date

2024-09-19

Brief Summary

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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

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Detailed Description

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Conditions

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Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment Arm

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

Group Type EXPERIMENTAL

AVTR101

Intervention Type DRUG

three times daily

Placebo Arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

three times daily

Interventions

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AVTR101

three times daily

Intervention Type DRUG

Placebo

three times daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No