DyslipidemiasPhase 2NCT05488431
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
A Phase 2 study testing Bempedoic acid in people with Dyslipidemias and Cardiovascular Diseases, run by Priscilla Hsue, MD at 3 sites in United States.
Trial summary
This is a randomized placebo-controlled study in treated and suppressed HIV-infected individuals aged ≥40 years with either known CVD or 1 CVD risk factor to study the effect of Bempedoic acid (BA) on safety, arterial inflammation as assessed by FDG-PET/CT, lipids, inflammation, immune activation, cardiometabolic… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Dyslipidemias, Cardiovascular Diseases, HIV Infections
- What is being tested?
- Bempedoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2023to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented HIV infection
- On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
- CD4 T-cell count ≥ 200 cells/mm3
- Male or female between the ages ≥ 40 years of age
- LDL-C ≥ 50 mg/dL
- Documented cardiovascular disease as defined by: 1. Prior myocardial infarction, 2. Prior cerebrovascular disease, 3. Prior peripheral arterial disease, 4. History of percutaneous coronary intervention, 5. History of coronary artery bypass graft OR 6. Angiographic evidence of >50% stenosis in at least one coronary artery] OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
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- TBR of >1.6 of the MDS of the carotid/aorta at baseline. This baseline arterial TBR cutoff excludes the rare individual that lacks appreciable arterial inflammation. It is notable that while 5-10% of uninfected individuals will have lower TBRs, it is rare that an HIV infected individual will fall below this range.
- Female subjects must either be of non-childbearing potential (defined as post-menopausal or amenorrhea > 12 months) or agree to use two forms of contraception (one hormonal and one barrier) throughout the study and for at least one month following study completion and have a negative pregnancy test at screening and prior to the first dose of drug.
- Males must use at least one method of contraception throughout the study.
Who cannot join
- Pregnant/nursing women (as there is no data on bempedoic acid in this setting)
- Diabetes requiring insulin (as insulin treatment alters the uptake of 18FDG)
- Uncontrolled HTN as defined by baseline blood pressure reading of ≥160 mmHg systolic OR ≥100 mmHg diastolic (exclusion criteria in other studies with BA)
- AST/ALT or alkaline phosphatase >2x ULN
- Triglycerides >500 mg/dL at screening
- Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
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- Individuals on simvastatin >20mg or pravastatin >40mg. All other dosages and statins will be permitted with close monitoring for myopathies including assessment of CK levels
- Nephrotic syndrome or eGFR <30 mL/min/1.73m2
- Cytopenias which include 1) WBC <3.5 x103/uL 2) Platelet <120 x103/uL 3) ANC <1.5 x103/uL, and absolute lymphocytes <0.8 x 103/uL
- Anemia as fined by Hgb <10 g/dL
- Acute systemic infection within 30 days
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UT Health Houston
Houston, Texas, 77030
Brenda Lastra Bojorguez, brenda.lastrabojorquez@uth.tmc.edu
Jordan Lake, MD
- Recruiting
UCLA Center for Clinical AIDS Research and Education (CARE)
Los Angeles, California, 90095
Aleen Khodabakhshian, (310) 557-3798, akhodabakhshian@mednet.ucla.edu
Priscilla Hsue, MD
- Recruiting
San Francisco General Hospital
San Francisco, California, 94110
Marta Levkova, 628-206-8037, Marta.levkova@ucsf.edu
Priscilla Hsue, MD
About this study
This is a randomized placebo-controlled study in treated and suppressed HIV-infected individuals aged ≥40 years with either known CVD or 1 CVD risk factor to study the effect of Bempedoic acid (BA) on safety, arterial inflammation as assessed by FDG-PET/CT, lipids, inflammation, immune activation, cardiometabolic indices, and non-calcified plaque (NCP) in the coronary arteries (assessed by coronary CT angiography, CCTA). This trial will be enrolled at UCSF and UCLA. Collaborators at Massachusetts General Hospital (MGH) will serve as the core facility for imaging.
Read the detailed description
Persons living with HIV infection (PLWH) have a 2-fold higher risk of myocardial infarction and are twice as likely to develop cardiovascular disease accounting for a significant global burden of disease. While the mechanism underlying this excess risk remains poorly understood, studies demonstrate that atherosclerosis in the setting of HIV is distinct and characterized by heightened arterial inflammation as assessed by FDG-PET/CT. HIV and antiretroviral medication can worsen cardiometabolic parameters. Thus a therapeutic strategy that can lower lipids, inflammation, and improve glycemic parameters may be even more advantageous in HIV. Bempedoic acid (BA, an inhibitor of ATP citrate lyase), is safely tolerated, significantly lowers LDL-C and inflammatory markers (on top of statin therapy), and is FDA approved for individuals with heterozygous familial hypercholesterolemia or with established ASCVD who require additional LDL-C lowering. Additionally, BA has a protective effect on glycemic parameters and may reduce adiposity. Given the key role of lipids and inflammation in atherosclerosis in HIV, the purpose of this proof-of-concept mechanistic trial is to evaluate the impact of BA on the biology of HIV-associated atherosclerosis. This is a randomized placebo controlled study of effectively treated PLWH aged 40 years and older with either known CVD or 1 CVD risk factor to study the effect of BA on arterial inflammation (assessed by FDG-PET/CT), lipid levels, biomarkers of inflammatory/immune activation, cardiometabolic indices, and non-calcified plaque in the coronary arteries (assessed by CCTA). This multicenter trial will include PLWH enrolled at UCSF and UCLA. Long term collaborators at MGH will serve as the core facility for the imaging end-points. There are three specific aims for the: Cholesterol and inflammation Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial): Aim 1: To determine whether BA can safely reduce arterial inflammation including carotid plaque as assessed by FDG-PET/CT; Aim 2: To determine whether BA improves cardiometabolic measures (lipid, inflammatory, glycemic and adipose parameters) among PLWH. Exploratory objectives will be to assess BA's effect (vs. placebo) on glycemic as well as adipose tissue measures (HbA1c, HOMA IR, and adipose tissue volumes); Aim 3: To evaluate the impact of BA on non-calcified coronary plaque volume as measured by coronary CT angiography (CCTA).
- Being tested
- Bempedoic acid, Placebo
- Medical subject headings
- Dyslipidemias, Cardiovascular Diseases, HIV Infections, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic acidDrug
Also called BA
Bempedoic Acid is an oral first-in-class small molecular adenosine triphosphate (ATP)-citrate lyase (ACL) inhibitor which lowers LDL-C by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Inhibition of ACL by bempedoyl-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of LDL receptors and concomitant suppression of hepatic fatty acid biosynthesis. BA has been studied in >4300 individuals and is currently being studied in >14,000 individuals in CLEAR Outcomes (NCT02993406).
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Bempedoic acid (BA) | Experimental | Patients randomized into the BA arm will receive 180 mg BA administered orally once daily without food for 52 weeks. Receives: Drug: Bempedoic acid |
| Placebo | Placebo comparator | Patients randomized into the placebo arm will receive 180 mg placebo administered orally once daily without food for 52 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDG PET/CT Endpoint
Change in Target-to-background ratio from baseline to follow-up study at 52 weeks. The main arterial endpoint is the most diseased segment of the index vessel. These findings will be correlated to measurements in the secondary endpoint.
Measured: Baseline and Week 52
Secondary outcomes (22)
Total Cholesterol Endpoint
Change in total cholesterol will be assessed from baseline to week 24 and week 52.
Measured: Baseline, Week 24 and Week 52
HDL Endpoint
Change in HDL will be assessed from baseline to week 24 and week 52.
Measured: Baseline, Week 24 and Week 52
LDL Endpoint
Change in LDL will be assessed from baseline to week 24 and week 52.
Measured: Baseline, Week 24 and Week 52
Triglycerides Endpoint
Change in triglycerides will be assessed from baseline to week 24 and week 52.
Measured: Baseline, Week 24 and Week 52
Apolipoprotein B Endpoint
Change in apolipoprotein B will be assessed from baseline to week 24 and week 52.
Measured: Baseline, Week 24 and Week 52
Hb A1c Endpoint
Change in HbA1c from baseline to week 24 and week 52.
Measured: Baseline, Week 24 and Week 52
Fasting glucose Endpoint
Change in fasting glucose measurements from baseline to week 24 and week 52.
Measured: Baseline, Week 24 and Week 52
Insulin Endpoint
Change in insulin measurements from baseline to week 24 and week 52.
Measured: Baseline, Week 24 and Week 52
homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Endpoints
The change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), a calculation based on insulin and glucose, will also be assessed from baseline to week 24 and 52.
The equation simplifies to [HOMA-IR = fasting insulin *fasting glucose /22.5] where fasting plasma insulin is measured in (µIU/mL) and fasting plasma glucose is measured in (mmol/L). Values below 1.0 are generally considered optimal.
Measured: Baseline, Week 24 and Week 52
Adipose Volume Endpoint
Change in adipose tissue volumes will be assessed by FDG PET/CT (as measured in primary outcome) from baseline to week 52.
Measured: Baseline and Week 52
hsCRP Endpoint
Change in hsCRP from baseline to follow-up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
IL-1B Endpoint
Change in IL-1B from baseline to follow-up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
IL-18 Endpoint
Change in IL-18 from baseline to follow-up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
SAA Endpoint
Change in SAA from baseline to follow-up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
Lp-PLA2 Endpoint
Change in Lp-PLA2 from baseline to follow-up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
sCD163 Endpoint
Change in sCD163 from baseline to follow-up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
IL-6 Endpoint
Change in IL-6 from baseline to follow-up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
D-Dimer Endpoint
Change in D-Dimer from baseline to follow-up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
Fibrinogen Endpoint
Change in fibrinogen from baseline to follow-up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
T-cell Endpoint
Change in T-cell marker from baseline to follow up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
B-cell Endpoint
Change in B-cell marker from baseline to follow up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
Monocyte activation Endpoint
Change in monocyte activation marker from baseline to follow up at weeks 24 and 52.
Measured: Baseline, Week 24 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Mar 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Priscilla Hsue, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Priscilla Hsue, MD, University of California, San Francisco
- Investigators
- Priscilla Hsue, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488431
- Sponsor's protocol ID
- 1.0
- Status last verified
- Dec 2025
- First submitted
- 25 Jul 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
- ClinicalTrials.gov ID
- NCT05488431
- Acronym / sponsor ID
- 1.0
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Priscilla Hsue, MDUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Massachusetts General Hospital
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 4 Aug 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.
This is a randomized placebo-controlled study in treated and suppressed HIV-infected individuals aged ≥40 years with either known CVD or 1 CVD risk factor to study the effect of Bempedoic acid (BA) on safety, arterial inflammation as assessed by FDG-PET/CT, lipids, inflammation, immune activation, cardiometabolic indices, and non-calcified plaque (NCP) in the coronary arteries (assessed by coronary CT angiography, CCTA). This trial will be enrolled at UCSF and UCLA. Collaborators at Massachusetts General Hospital (MGH) will serve as the core facility for imaging.
Detailed description
Persons living with HIV infection (PLWH) have a 2-fold higher risk of myocardial infarction and are twice as likely to develop cardiovascular disease accounting for a significant global burden of disease. While the mechanism underlying this excess risk remains poorly understood, studies demonstrate that atherosclerosis in the setting of HIV is distinct and characterized by heightened arterial inflammation as assessed by FDG-PET/CT. HIV and antiretroviral medication can worsen cardiometabolic parameters. Thus a therapeutic strategy that can lower lipids, inflammation, and improve glycemic parameters may be even more advantageous in HIV. Bempedoic acid (BA, an inhibitor of ATP citrate lyase), is safely tolerated, significantly lowers LDL-C and inflammatory markers (on top of statin therapy), and is FDA approved for individuals with heterozygous familial hypercholesterolemia or with established ASCVD who require additional LDL-C lowering. Additionally, BA has a protective effect on glycemic parameters and may reduce adiposity. Given the key role of lipids and inflammation in atherosclerosis in HIV, the purpose of this proof-of-concept mechanistic trial is to evaluate the impact of BA on the biology of HIV-associated atherosclerosis. This is a randomized placebo controlled study of effectively treated PLWH aged 40 years and older with either known CVD or 1 CVD risk factor to study the effect of BA on arterial inflammation (assessed by FDG-PET/CT), lipid levels, biomarkers of inflammatory/immune activation, cardiometabolic indices, and non-calcified plaque in the coronary arteries (assessed by CCTA). This multicenter trial will include PLWH enrolled at UCSF and UCLA. Long term collaborators at MGH will serve as the core facility for the imaging end-points. There are three specific aims for the: Cholesterol and inflammation Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial): Aim 1: To determine whether BA can safely reduce arterial inflammation including carotid plaque as assessed by FDG-PET/CT; Aim 2: To determine whether BA improves cardiometabolic measures (lipid, inflammatory, glycemic and adipose parameters) among PLWH. Exploratory objectives will be to assess BA's effect (vs. placebo) on glycemic as well as adipose tissue measures (HbA1c, HOMA IR, and adipose tissue volumes); Aim 3: To evaluate the impact of BA on non-calcified coronary plaque volume as measured by coronary CT angiography (CCTA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bempedoic acid (BA) | Experimental | Drug: Bempedoic acidPatients randomized into the BA arm will receive 180 mg BA administered orally once daily without food for 52 weeks. |
| Placebo | Placebo comparator | Other: PlaceboPatients randomized into the placebo arm will receive 180 mg placebo administered orally once daily without food for 52 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Documented HIV infection
- On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
- CD4 T-cell count ≥ 200 cells/mm3
- Male or female between the ages ≥ 40 years of age
- LDL-C ≥ 50 mg/dL
Key exclusion criteria (11 listed)
- Pregnant/nursing women (as there is no data on bempedoic acid in this setting)
- Diabetes requiring insulin (as insulin treatment alters the uptake of 18FDG)
- Uncontrolled HTN as defined by baseline blood pressure reading of ≥160 mmHg systolic OR ≥100 mmHg diastolic (exclusion criteria in other studies with BA)
- AST/ALT or alkaline phosphatase >2x ULN
- Triglycerides >500 mg/dL at screening
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 |
|---|---|---|
| Bempedoic acidAlso: BABempedoic Acid is an oral first-in-class small molecular adenosine triphosphate (ATP)-citrate lyase (ACL) inhibitor which lowers LDL-C by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Inhibition of ACL by bempedoyl-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of LDL receptors and concomitant suppression of hepatic fatty acid biosynthesis. BA has been studied in >4300 individuals and is currently being studied in >14,000 individuals in CLEAR Outcomes (NCT02993406). | Drug | Bempedoic acid (BA) |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
FDG PET/CT Endpoint
Time frame: Baseline and Week 52
Change in Target-to-background ratio from baseline to follow-up study at 52 weeks. The main arterial endpoint is the most diseased segment of the index vessel. These findings will be correlated to measurements in the secondary endpoint.
22 secondary outcomes
Total Cholesterol Endpoint
Time frame: Baseline, Week 24 and Week 52
HDL Endpoint
Time frame: Baseline, Week 24 and Week 52
LDL Endpoint
Time frame: Baseline, Week 24 and Week 52
Triglycerides Endpoint
Time frame: Baseline, Week 24 and Week 52
Apolipoprotein B Endpoint
Time frame: Baseline, Week 24 and Week 52
Hb A1c Endpoint
Time frame: Baseline, Week 24 and Week 52
Fasting glucose Endpoint
Time frame: Baseline, Week 24 and Week 52
Insulin Endpoint
Time frame: Baseline, Week 24 and Week 52
homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Endpoints
Time frame: Baseline, Week 24 and Week 52
Adipose Volume Endpoint
Time frame: Baseline and Week 52
hsCRP Endpoint
Time frame: Baseline, Week 24 and Week 52
IL-1B Endpoint
Time frame: Baseline, Week 24 and Week 52
IL-18 Endpoint
Time frame: Baseline, Week 24 and Week 52
SAA Endpoint
Time frame: Baseline, Week 24 and Week 52
Lp-PLA2 Endpoint
Time frame: Baseline, Week 24 and Week 52
sCD163 Endpoint
Time frame: Baseline, Week 24 and Week 52
IL-6 Endpoint
Time frame: Baseline, Week 24 and Week 52
D-Dimer Endpoint
Time frame: Baseline, Week 24 and Week 52
Fibrinogen Endpoint
Time frame: Baseline, Week 24 and Week 52
T-cell Endpoint
Time frame: Baseline, Week 24 and Week 52
B-cell Endpoint
Time frame: Baseline, Week 24 and Week 52
Monocyte activation Endpoint
Time frame: Baseline, Week 24 and Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- 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.
Priscilla Hsue, MD principal investigator
University of California, Los Angeles
3 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 Bempedoic acid in people with Dyslipidemias and Cardiovascular Diseases, run by Priscilla Hsue, MD at 3 sites in United States.
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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Levkova (628-206-8037, marta.levkova@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDG PET/CT Endpoint (time frame: Baseline and Week 52). 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 17 Dec 2025.