SarcopeniaNCT05525039
RCT of Combination Effect of Vibration Treatment and HMB Supplementation on Myosteatosis and NMJ Degeneration
A study testing Low-magnitude High-frequency Vibration, β-hydroxy β-methylbutyrate (HMB) supplement and Protein supplement in people with Sarcopenia and Connective Tissue Diseases in Old Age, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
Trial summary
The investigators' pre-clinical study confirms the positive effects of combined treatment (VT + HMB) on reducing fat-to-lean tissue ratio, intramuscular fat infiltration and increasing muscle strength in sarcopenia animal model. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia, Connective Tissue Diseases in Old Age, Musculoskeletal Abnormalities
- What is being tested?
- Low-magnitude High-frequency Vibration, β-hydroxy β-methylbutyrate (HMB) supplement and Protein supplement
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 3 sitesHong Kong
- Study dates
- 12 Jan 2023to 4 May 2026
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 60 years or above
- Subjects failed in AWGS algorithm
- skeletal muscle mass by BIA (male at <7.0 kg/m^2, female at <5.7 kg/m^2), and
- handgrip strength (male at <28 kg, female at <18kg), and/or
- gait speed test (>1m/s)
Who cannot join
- Subjects with pathological bone diseases
- Subjects with chronic inflammatory condition (e.g. rheumatoid arthritis)
- Subjects with neurological problems
- Subjects receiving regular exercise
- Subjecs who are chair-/bed- bound
- Subjects with malignancy
- Subjects with cardiovascular concern such as with pace-maker in-situ
- Subjects with acute fractures or severe osteoarthritis
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Evangelical Luthera Church Social Service - Hong Kong
Hong Kong
The Chinese University of Hong Kong Jockey Club Centre for Osteoporosis Care and Control
Hong Kong
The Chinese University of Hong Kong, Department of Orthopaedics and Traumatology, 1/F Li Ka Shing Outpatient Clinic (North), PWH
Hong Kong
About this study
Official title: Dissecting the Therapeutic Mechanism of an Effective Combination Treatment Targeting Neuromuscular Junction Dengeneration and Myosteatosis to Combat Sarcopenia
The investigators' pre-clinical study confirms the positive effects of combined treatment (VT + HMB) on reducing fat-to-lean tissue ratio, intramuscular fat infiltration and increasing muscle strength in sarcopenia animal model. The results showed that fat mass could be decreased by ~32%, while histology Oil Red O staining indicated a decrease of fat by almost 60%; in contrast, lean muscle mass increased by ~14%. On muscle strength, combined treatment increased twitch force, tetanic force and grip strength by ~30-66%. These in vivo results are very encouraging and the investigators should explore its potential in clinical translation. As VT and HMB supplement have been commercially available and their compliance rates are satisfactory, they can be translated to clinical application easily. The investigators' next step is to confirm its clinical efficacy, so that sarcopenia becomes a new indication of VT and HMB. The hypothesis is that combined treatment of VT and HMB can retard the progression of sarcopenia in human, in terms of muscle mass, muscle strength and performance.
Read the detailed description
In this study, a single-blinded RCT is to investigate the effect of combination treatment of VT and HMB on hand grip, gait speed, muscle mass (DXA) in sarcopenic subjects.
Subjects over age of 65 will be screened by performing SARC-F, handgrip, gait speed and bioelectric impedance assessment (BIA) based on AWGS definition. The participants failed in AWGS algorithm will be invited to join the research. Exclusion criteria are those with (1)pathological bone diseases, (2) chronic inflammatory conditions (e.g. rheumatoid arthritis), (3) neurological problems affecting gait, (4) taking regular supervised exercise training for more than 3 times/week, (5) chair-bound or bed-bound, and (6) malignancy.
Recruited subjects will be randomized to either (1) Control, (2) HMB only, (3) VT only or (4) HMB +VT group. All subjects will be given protein supplement to ensure minimal daily protein intake. Subject assigned to VT group will receive VT (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. Subjects assigned to HMB group will take HMB capsules 3g/day for 6 months. Subjects assigned to HMB+VT group will recieve both VT and HMB supplements for 6 months. The primary outcome is muscle strength showing subjects' functional ability. All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline, 3 months and 6 months post-treatment.
- Being tested
- Low-magnitude High-frequency Vibration, β-hydroxy β-methylbutyrate (HMB) supplement, Protein supplement
- Keywords
- Sarcopenia, Vibration, Hydroxymethylbutyrate
- Medical subject headings
- Sarcopenia, Musculoskeletal Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-magnitude High-frequency VibrationDevice
Also called Vibration Treatment
0.3g, 35Hz, 20mins/day, at least 3 times/week
β-hydroxy β-methylbutyrate (HMB) supplementDietary supplement
Oral nutritional HMB supplement at 3g/day
Protein supplementDietary supplement
Daily protein supplement intake
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Subjects assigned to Contro Group will not receive VT or HMB. They will receive daily protein supplement for 6 months. Receives: Dietary Supplement: Protein supplement |
| HMB only Group | Active comparator | Subjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months. Receives: Dietary Supplement: β-hydroxy β-methylbutyrate (HMB) supplement; Dietary Supplement: Protein supplement |
| VT only Group | Active comparator | Subjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months Receives: Device: Low-magnitude High-frequency Vibration; Dietary Supplement: Protein supplement |
| HMB + VT Group | Experimental | Subjects assigned to HMB + VT Group will receive HMB supplement at 3g/day, VT at least 3 times/week and daily protein supplement for 6 months. Receives: Device: Low-magnitude High-frequency Vibration; Dietary Supplement: β-hydroxy β-methylbutyrate (HMB) supplement; Dietary Supplement: Protein supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength-handgrip
Handgrip strength will be measured by a dynamometer on each hand of the subject.
Measured: 6 months
Muscle performance-gait speed
Gait speed will be assessed by a 6-meter-walk test.
Measured: 6 months
Secondary outcomes (5)
Dual energy x-ray absortiometry (DXA)
Whole body muscle mass measurement
Measured: 6 months
Biodex Balance System-LOS
Limits of stability will be recorded to evaluate the dynamic posture stability. Maximum scores will be 100 where the higher scores indicate better performance.
Measured: 6 months
Biodex Balance System-OSI
Posture stability (Overall Stability Index) will be recorded. High scores indicate poorer balancing abillity.
Measured: 6 months
Time-up-and-go test (TUG)
Time will be recorded for participants to rise from a chair, walk 3 meters, turn around, and walk back to the chair then sitting down
Measured: 6 months
36-item Short-Form Health Survey (SF-36)
Health-related quality of life will be assessed by the validated Chinese version of SF-36. Scores range from 0 to 100 where higher scores indicate better health status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start12 Jan 2023
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to either (1) Control, (2) HMB only, (3) VT only or (4) HMB +VT group. All subjects will be given protein supplement to ensure minimal daily protein intake. Subject assigned to VT group will receive VT (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. Subjects assigned to HMB group will take HMB capsules 3g/day for 6 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Professor CHEUNG Wing hoi, Louis, Chinese University of Hong Kong
- Investigators
- Wing Hoi Cheung, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525039
- Sponsor's protocol ID
- CREC 2022.233-T
- Status last verified
- Mar 2026
- First submitted
- 30 Aug 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.
PubMed 24676848Wang J, Cui C, Chim YN, Yao H, Shi L, Xu J, Wang J, Wong RMY, Leung KS, Chow SK, Cheung WH. Vibration and beta-hydroxy-beta-methylbutyrate treatment suppresses intramuscular fat infiltration and adipogenic differentiation in sarcopenic mice. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):564-577. doi: 10.1002/jcsm.12535. Epub 2020 Jan 28.
PubMed 31994349Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4.
PubMed 23514626Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency whole-body vibration improves balancing ability in elderly women. Arch Phys Med Rehabil. 2007 Jul;88(7):852-7. doi: 10.1016/j.apmr.2007.03.028.
PubMed 17601464Zhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179.
PubMed 30462162Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
PubMed 24461239Li MCM, Cheng YK, Cui C, Chow SKH, Wong RMY, Kwok TC, Siu PM, Yang M, Tian M, Rubin C, Welch AA, Qin L, Law SW, Cheung WH. Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial. BMJ Open. 2024 Jan 4;14(1):e074858. doi: 10.1136/bmjopen-2023-074858.
PubMed 38176874
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting the Therapeutic Mechanism of an Effective Combination Treatment Targeting Neuromuscular Junction Dengeneration and Myosteatosis to Combat Sarcopenia
- ClinicalTrials.gov ID
- NCT05525039
- Acronym / sponsor ID
- CREC 2022.233-T
- Keywords
- Sarcopenia, Vibration, Hydroxymethylbutyrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 1 Sep 2022 (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 investigators' pre-clinical study confirms the positive effects of combined treatment (VT + HMB) on reducing fat-to-lean tissue ratio, intramuscular fat infiltration and increasing muscle strength in sarcopenia animal model. The results showed that fat mass could be decreased by ~32%, while histology Oil Red O staining indicated a decrease of fat by almost 60%; in contrast, lean muscle mass increased by ~14%. On muscle strength, combined treatment increased twitch force, tetanic force and grip strength by ~30-66%. These in vivo results are very encouraging and the investigators should explore its potential in clinical translation. As VT and HMB supplement have been commercially available and their compliance rates are satisfactory, they can be translated to clinical application easily. The investigators' next step is to confirm its clinical efficacy, so that sarcopenia becomes a new indication of VT and HMB. The hypothesis is that combined treatment of VT and HMB can retard the progression of sarcopenia in human, in terms of muscle mass, muscle strength and performance.
Detailed description
In this study, a single-blinded RCT is to investigate the effect of combination treatment of VT and HMB on hand grip, gait speed, muscle mass (DXA) in sarcopenic subjects.
Subjects over age of 65 will be screened by performing SARC-F, handgrip, gait speed and bioelectric impedance assessment (BIA) based on AWGS definition. The participants failed in AWGS algorithm will be invited to join the research. Exclusion criteria are those with (1)pathological bone diseases, (2) chronic inflammatory conditions (e.g. rheumatoid arthritis), (3) neurological problems affecting gait, (4) taking regular supervised exercise training for more than 3 times/week, (5) chair-bound or bed-bound, and (6) malignancy.
Recruited subjects will be randomized to either (1) Control, (2) HMB only, (3) VT only or (4) HMB +VT group. All subjects will be given protein supplement to ensure minimal daily protein intake. Subject assigned to VT group will receive VT (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. Subjects assigned to HMB group will take HMB capsules 3g/day for 6 months. Subjects assigned to HMB+VT group will recieve both VT and HMB supplements for 6 months. The primary outcome is muscle strength showing subjects' functional ability. All primary and secondary outcome assessments for all groups will be performed in the investigators' institute at baseline, 3 months and 6 months post-treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Subjects will be randomized to either (1) Control, (2) HMB only, (3) VT only or (4) HMB +VT group. All subjects will be given protein supplement to ensure minimal daily protein intake. Subject assigned to VT group will receive VT (35Hz, 0.3g, 20min/day, at least 3 times/week) for 6 months. Subjects assigned to HMB group will take HMB capsules 3g/day for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Dietary Supplement: Protein supplementSubjects assigned to Contro Group will not receive VT or HMB. They will receive daily protein supplement for 6 months. |
| HMB only Group | Active comparator | Dietary Supplement: β-hydroxy β-methylbutyrate (HMB) supplement, Dietary Supplement: Protein supplementSubjects assigned to HMB only Group will receive HMB supplement at 3g/day and daily protein supplement for 6 months. |
| VT only Group | Active comparator | Device: Low-magnitude High-frequency Vibration, Dietary Supplement: Protein supplementSubjects assigned to VT only Group will receive VT (0.3g, 35Hz, at least 3 times/week) and daily protein supplement for 6 months |
| HMB + VT Group | Experimental | Device: Low-magnitude High-frequency Vibration, Dietary Supplement: β-hydroxy β-methylbutyrate (HMB) supplement, Dietary Supplement: Protein supplementSubjects assigned to HMB + VT Group will receive HMB supplement at 3g/day, VT at least 3 times/week and daily protein supplement for 6 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects aged 60 years or above
- Subjects failed in AWGS algorithm
Key exclusion criteria (8 listed)
- Subjects with pathological bone diseases
- Subjects with chronic inflammatory condition (e.g. rheumatoid arthritis)
- Subjects with neurological problems
- Subjects receiving regular exercise
- Subjecs who are chair-/bed- bound
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 |
|---|---|---|
| Low-magnitude High-frequency VibrationAlso: Vibration Treatment0.3g, 35Hz, 20mins/day, at least 3 times/week | Device | HMB + VT Group, VT only Group |
| β-hydroxy β-methylbutyrate (HMB) supplementOral nutritional HMB supplement at 3g/day | Dietary supplement | HMB + VT Group, HMB only Group |
| Protein supplementDaily protein supplement intake | Dietary supplement | Control Group, HMB + VT Group, HMB only Group, VT only Group |
Primary outcome
Muscle strength-handgrip
Time frame: 6 months
Handgrip strength will be measured by a dynamometer on each hand of the subject.
Muscle performance-gait speed
Time frame: 6 months
Gait speed will be assessed by a 6-meter-walk test.
5 secondary outcomes
Dual energy x-ray absortiometry (DXA)
Time frame: 6 months
Biodex Balance System-LOS
Time frame: 6 months
Biodex Balance System-OSI
Time frame: 6 months
Time-up-and-go test (TUG)
Time frame: 6 months
36-item Short-Form Health Survey (SF-36)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 24676848Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.
- Background: PubMed 31994349Wang J, Cui C, Chim YN, Yao H, Shi L, Xu J, Wang J, Wong RMY, Leung KS, Chow SK, Cheung WH. Vibration and beta-hydroxy-beta-methylbutyrate treatment suppresses intramuscular fat infiltration and adipogenic differentiation in sarcopenic mice. J Cachexia Sarcopenia Muscle. 2020 Apr;11(2):564-577. doi: 10.1002/jcsm.12535. Epub 2020 Jan 28.
- Background: PubMed 23514626Deutz NE, Pereira SL, Hays NP, Oliver JS, Edens NK, Evans CM, Wolfe RR. Effect of beta-hydroxy-beta-methylbutyrate (HMB) on lean body mass during 10 days of bed rest in older adults. Clin Nutr. 2013 Oct;32(5):704-12. doi: 10.1016/j.clnu.2013.02.011. Epub 2013 Mar 4.
- Background: PubMed 17601464Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency whole-body vibration improves balancing ability in elderly women. Arch Phys Med Rehabil. 2007 Jul;88(7):852-7. doi: 10.1016/j.apmr.2007.03.028.
- Background: PubMed 30462162Zhu LY, Chan R, Kwok T, Cheng KC, Ha A, Woo J. Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial. Age Ageing. 2019 Mar 1;48(2):220-228. doi: 10.1093/ageing/afy179.
- Background: PubMed 24461239Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
- Derived from this study: PubMed 38176874Li MCM, Cheng YK, Cui C, Chow SKH, Wong RMY, Kwok TC, Siu PM, Yang M, Tian M, Rubin C, Welch AA, Qin L, Law SW, Cheung WH. Biophysical and nutritional combination treatment for myosteatosis in patients with sarcopenia: a study protocol for single-blinded randomised controlled trial. BMJ Open. 2024 Jan 4;14(1):e074858. doi: 10.1136/bmjopen-2023-074858.
- Individual participant dataSharing planned: No
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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.
Wing Hoi Cheung, PhD principal investigator
Chinese University of Hong Kong
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-magnitude High-frequency Vibration, β-hydroxy β-methylbutyrate (HMB) supplement and Protein supplement in people with Sarcopenia and Connective Tissue Diseases in Old Age, run by Chinese University of Hong Kong at 3 sites in Hong Kong.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle strength-handgrip (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525039, which also lists 7 linked publications.
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 21 Oct 2026.