SarcopeniaPhase 2NCT06788236
Study of Efficacy and Safety of AVTR101 in Sarcopenic Elderly
A Phase 2 study testing AVTR101 in people with Sarcopenia, run by Aventi Biotechnology Inc. at 4 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- AVTR101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 23 May 2022to 19 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Asan Medical Center
Seoul, Seoul, 05505
SMG-SNU Boramae Medical Center
Seoul, Seoul, 07061
Ajou University School of Medicine
Suwon, Gyeonggi-do, 16499
About this study
Official title: 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
- Conditions
- Sarcopenia
- Being tested
- AVTR101, Placebo
- Keywords
- Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVTR101Drug
three times daily
PlaceboDrug
three times daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects will take one 120 mg capsule (test drug) three times daily for a total treatment duration of 12 weeks. Receives: Drug: AVTR101 |
| Placebo Arm | Placebo comparator | Subjects will take one placebo capsule three times daily for a total treatment duration of 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start23 May 2022
- Primary completion14 Jun 2024
- Study completion19 Sep 2024
Why it stopped: Due subject enrollment delay and to secure expiration of the test drug, it was necessary to minimize the subject enrollment period. In addition, it was deemed advantageous to increase the overall efficiency of the clinical program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aventi Biotechnology Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Bundang Hospital, Ajou University School of Medicine, SMG-SNU Boramae Medical Center, Asan Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788236
- Sponsor's protocol ID
- AV-R101-211
- Status last verified
- Apr 2025
- First submitted
- 11 Dec 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 2a Clinical Trial to Evaluate the Efficacy and Safety of AVTR101 in Sarcopenia Patients
- ClinicalTrials.gov ID
- NCT06788236
- Acronym / sponsor ID
- AV-R101-211
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due subject enrollment delay and to secure expiration of the test drug, it was necessary to minimize the subject enrollment period. In addition, it was deemed advantageous to increase the overall efficiency of the clinical program.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aventi Biotechnology Inc.Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Bundang Hospital, Ajou University School of Medicine, SMG-SNU Boramae Medical Center, Asan Medical Center
- Study start
- 23 May 2022 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: AVTR101Subjects will take one 120 mg capsule (test drug) three times daily for a total treatment duration of 12 weeks. |
| Placebo Arm | Placebo comparator | Drug: PlaceboSubjects will take one placebo capsule three times daily for a total treatment duration of 12 weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVTR101three times daily | Drug | Treatment Arm |
| Placebothree times daily | Drug | Placebo Arm |
Primary outcome
Change in SPPB total score at 12 weeks
Time frame: From enrollment to the end of treatment 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.
7 secondary outcomes
Change in SPPB total score at 4, 8 weeks
Time frame: From enrollment to the end of treatment at 4, 8 weeks
Change in 5-STS time
Time frame: From enrollment to the end of treatment at 4, 8, 12 weeks
Change in 6m walk speed
Time frame: From enrollment to the end of treatment at 4, 8, 12 weeks
Change in ASM measured by DXA
Time frame: From enrollment to the end of treatment at 12 weeks
Change in handgrip strength
Time frame: From enrollment to the end of treatment at 4, 8, 12 weeks
Change in SARC-F total score
Time frame: From enrollment to the end of treatment at 12 weeks
Change in SarQoL: total score
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study was stopped early (reason given: Due subject enrollment delay and to secure expiration of the test drug, it was necessary to minimize the subject enrollment period. In addition, it was deemed advantageous to increase the overall efficiency of the clinical program.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVTR101 in people with Sarcopenia, run by Aventi Biotechnology Inc. at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due subject enrollment delay and to secure expiration of the test drug, it was necessary to minimize the subject enrollment period. In addition, it was deemed advantageous to increase the overall efficiency of the clinical program.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SPPB total score at 12 weeks (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.