Nonalcoholic Fatty Liver DiseasePhase 2VEDSNCT04801849
Vitamin E Dosing Study
A Phase 2 study testing Vitamin E in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 9 sites in United States.
Trial summary
This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- What is being tested?
- Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 9 sitesUnited States
- Study dates
- 5 Aug 2022to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older as of the initial screening interview and provision of consent
- FibroScan CAP>280 dB/m within 60 days prior to randomization.
- ALT ≥ 60 U/L within 30 days of randomization
Who cannot join
- Concurrent or prior use (within 90 days) of vitamin E supplements in excess of 40 IU/day
- Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day (~1.5 drinks/day) (> 10.5 drinks per week) in females and more than 30 g/day (~2 drinks/day) (>14 drinks per week) in males, respectively. One "standard" drink (or one alcoholic drink equivalent) contains roughly 14 grams of pure alcohol, which is found in: 12 ounces of regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits).
- Inability to reliably quantify alcohol consumption based upon local study physician judgment
- Continued use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the 6 months prior to randomization
- Current use of anticoagulation therapy (not including antiplatelet agents such as aspirin or clopidogrel)
- Platelet count below 150,000 /mm3 within 90 days of randomization
Show all 38Show fewer
- History of condition(s) that cause increased risk of bleeding, including hemophilia A, hemophilia B, von Willebrand disease, or other clotting factor deficiencies.
- Prior or planned (during the study period) bariatric surgery (eg, gastroplasty, roux-en-Y gastric bypass)
- Uncontrolled diabetes defined as HbA1c 9.5% or higher within 60 days prior to randomization
- Clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities:
- Serum albumin less than 3.2 g/dL
- International Normalized Ratio (INR) greater than 1.3
- Direct bilirubin greater than 1.0 mg/dL
- History of esophageal varices, ascites or hepatic encephalopathy
- Evidence of other forms of chronic liver disease:
- Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg)
- Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA
- Evidence of ongoing autoimmune liver disease as defined by compatible liver histology
- Primary biliary cirrhosis as defined by the presence of at least 2 of these criteria (i) Biochemical evidence of cholestasis based mainly on alkaline phosphatase elevation (ii) Presence of anti-mitochondrial antibody (AMA) (iii) Histologic evidence of nonsuppurative destructive cholangitis and destruction of interlobular bile ducts[1]
- Primary sclerosing cholangitis
- Known history of Wilson disease, alpha-1-antitrypsin liver disease, or hemochromatosis. Any other type of liver disease that is currently active other than NASH such as drug-induced liver disease, liver cancer, or bile duct obstruction.
- Serum alanine aminotransferase (ALT) greater than 400 U/L within 90 days of randomization
- Moderate or severe renal impairment (serum creatinine ≥ 2.0 mg/dL or eGFR < 60 mg/mL/1.73m2)
- History of biliary diversion or evidence of current biliary obstruction
- Known positivity for Human Immunodeficiency Virus (HIV) infection
- Active, serious medical disease with likely life expectancy less than 5 years
- Active substance abuse including inhaled or injection drugs in the year prior to screening
- Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use ≥ 1 effective form(s) of birth control during the trial, breast feeding
- Current use of medications that may impact the absorption of fat-soluble vitamins (i.e. orlistat or cholestyramine)
- Pre-existing history of fat malabsorption
- Males at high risk of prostate cancer, including:
- PSA >ULN at baseline
- History of prostate cancer
- Age 45 or older with a first-degree relative (father or brother) diagnosed with prostate cancer at an early age (younger than age 65).
- Age 40 or older with more than one first-degree relative who had prostate cancer at an early age (younger than age 65)
- Participation in an IND trial in the 30 days before randomization
- Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study, including inability to swallow treatment capsules
- Failure or inability to give informed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Indiana University- Adults
Indianapolis, Indiana, 46202
University of California, San Diego
La Jolla, California, 92103
University of Southern California
Los Angeles, California, 90089
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California, San Francisco
San Francisco, California, 94143
Liver Institute Northwest
Seattle, Washington, 98105
St. Louis University
St Louis, Missouri, 63110
About this study
Official title: Vitamin E Dosing Study (VEDS): A Dose Finding Study of Vitamin E for the Treatment of Adult NAFLD
This is a multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).
Read the detailed description
Adults age 18 years or older will be enrolled for 48 weeks and treated with 200 international units (IU), 400 IU, or 800 IU of Vitamin E or matching placebo for 24 weeks. The primary objective of the study is to determine the minimum effective dose of Vitamin E (d-alpha-tocopherol) based upon relative change in alanine aminotransferase (ALT) from baseline to 24 weeks.
- Being tested
- Vitamin E, Placebo
- Keywords
- Vitamin E, Nonalcoholic Fatty Liver Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
Also called d-alpha-tocopherol
Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
PlaceboDrug
Participants will take a placebo vitamin E capsule daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E, 200 IU | Active comparator | 200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Receives: Drug: Vitamin E |
| Vitamin E, 400 IU | Active comparator | 400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Receives: Drug: Vitamin E |
| Vitamin E, 800 IU | Active comparator | 800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast Receives: Drug: Vitamin E |
| Placebo | Placebo comparator | matching placebo taken once daily with breakfast Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change in Alanine Aminotransferase (ALT) From Baseline to 24 Weeks
Percent change from baseline to 24 weeks relative to baseline measure of ALT.
Measured: Baseline to 24 weeks (end of treatment)
Secondary outcomes (17)
Proportion of Patients Achieving Normalization of Alanine Aminotransferase (ALT) at 24 Weeks
Normalization of ALT (U/L) is defined as a decrease in ALT to less than or equal to the ULN at the 24 week visit among participants who had an ALT value greater than ULN at baseline. Values for upper limits of normal (ULN) are defined at each clinical center per institutional guidelines.
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Serum Alanine Aminotransferase (ALT) From Baseline
ALT value in U/L
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Serum Aspartate Aminotransferase (AST) From Baseline
AST value in U/L
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Hepatic Steatosis (Fat in the Liver) Determined by Fibroscan® Controlled Attenuation Parameter (CAP) Software Function
CAP (Control Attenuation Parameter) is expressed in decibels per meter (dB/m). This value is the median of all valid measurements performed during the examination. It ranges from 100 to 400 dB/m. Higher dB/m indicates worse liver fat.
Measured: Baseline to24 weeks (end of treatment)
Mean Change in Liver Stiffness From Baseline Assessed by Fibroscan®
Fibroscan® measures stiffness in kiloPascal's (kPa) and ranges from 2 to 75. Normal range of FibroScan is between 2 to 7 kPa, and the average normal result is 5.3kPa. Higher kPa means more stiffness (scarring).
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Gamma-glutamyl Transferase (GGT) From Baseline to 24 Weeks
GGT is measured in U/L
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Glucose From Baseline to 24 Weeks
Fasting glucose measured in mg/dL
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Weight From Baseline to 24 Weeks
Weight measured in kilograms (kg)
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Body Mass Index (BMI) From Baseline to 24 Weeks
BMI is reported in kg/m-squared
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Waist Circumference From Baseline to 24 Weeks
Waist circumference measured in centimeters (cm)
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Waist-to-hip Ratio From Baseline to 24 Weeks
Waist-to-hip ratio from baseline to 24 weeks
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in Liver Symptom Questionnaire Total Score
The Liver Symptom Questionnaire scores 10 symptoms of liver disease on a scale of 1-5. Higher scores mean higher symptom severity. Total score can range from 10-50.
Measured: Baseline to 24 weeks (end of treatment)
Mean Change in ALT From 24 to 48 Weeks
Change in ALT (U/L) during off treatment phase
Measured: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in AST From 24 to 48 Weeks
AST value in U/L
Measured: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in GGT From 24 to 48 Weeks
GGT is measured in U/L
Measured: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in Controlled Attenuation Parameter (CAP) From 24 to 48 Weeks
CAP (Control Attenuation Parameter) is expressed in decibels per meter (dB/m). This value is the median of all valid measurements performed during the examination. It ranges from 100 to 400 dB/m. Higher dB/m indicates worse liver fat.
Measured: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in Liver Stiffness Measure (LSM) From 24 to 48 Weeks
LSM is measured in kPa
Measured: 24 weeks (end of treatment) to 48 weeks (final study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start5 Aug 2022
- Primary completion4 Mar 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, randomized, double masked, placebo-controlled, parallel treatment groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Duke University, Liver Institute Northwest, Indiana University, St. Louis University, University of California, San Diego, University of Southern California, University of California, San Francisco, Virginia Commonwealth University, The Cleveland Clinic, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Arun Sanyal, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801849
- Sponsor's protocol ID
- 10 VEDS
- Other IDs
- U24DK061730, U01DK061732, U01DK061713, U01DK061737, U01DK061728, U01DK061718, U01DK061734, U01DK061738
- Acronym
- VEDS
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2021
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the 2013 NIH Data Sharing Policy. Results and information from this trial will be submitted to ClinicalTrials.gov and a public use database deposited with the NIDDK Central Repository within two years of the date that the database is locked for analysis (interventional studies, primary and secondary outcomes).
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin E Dosing Study (VEDS): A Dose Finding Study of Vitamin E for the Treatment of Adult NAFLD
- ClinicalTrials.gov ID
- NCT04801849
- Acronym / sponsor ID
- VEDS / 10 VEDS
- Keywords
- Vitamin E, Nonalcoholic Fatty Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Duke University, Liver Institute Northwest, Indiana University, St. Louis University, University of California, San Diego, University of Southern California, University of California, San Francisco, Virginia Commonwealth University, The Cleveland Clinic, Johns Hopkins Bloomberg School of Public Health
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Posted 25 Mar 2026
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 multicenter, randomized, double masked, placebo-controlled, parallel treatment groups dosing trial of Vitamin E in adult nonalcoholic fatty liver disease (NAFLD).
Detailed description
Adults age 18 years or older will be enrolled for 48 weeks and treated with 200 international units (IU), 400 IU, or 800 IU of Vitamin E or matching placebo for 24 weeks. The primary objective of the study is to determine the minimum effective dose of Vitamin E (d-alpha-tocopherol) based upon relative change in alanine aminotransferase (ALT) from baseline to 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- multicenter, randomized, double masked, placebo-controlled, parallel treatment groups
| Arm | Type | Receives |
|---|---|---|
| Vitamin E, 200 IU | Active comparator | Drug: Vitamin E200 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast |
| Vitamin E, 400 IU | Active comparator | Drug: Vitamin E400 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast |
| Vitamin E, 800 IU | Active comparator | Drug: Vitamin E800 IU of d-alpha tocopherol (vitamin E) taken once daily with breakfast |
| Placebo | Placebo comparator | Drug: Placebomatching placebo taken once daily with breakfast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older as of the initial screening interview and provision of consent
- FibroScan CAP>280 dB/m within 60 days prior to randomization.
- ALT ≥ 60 U/L within 30 days of randomization
Key exclusion criteria (38 listed)
- Concurrent or prior use (within 90 days) of vitamin E supplements in excess of 40 IU/day
- Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day (~1.5 drinks/day) (> 10.5 drinks per week) in females and more than 30 g/day (~2 drinks/day) (>14 drinks per week) in males, respectively. One "standard" drink (or one alcoholic drink equivalent) contains roughly 14 grams of pure alcohol, which is found in: 12 ounces of regular beer, 5 ounces of wine, or 1.5 ounces of distilled spirits).
- Inability to reliably quantify alcohol consumption based upon local study physician judgment
- Continued use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks in the 6 months prior to randomization
- Current use of anticoagulation therapy (not including antiplatelet agents such as aspirin or clopidogrel)
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 |
|---|---|---|
| Vitamin EAlso: d-alpha-tocopherolParticipants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks | Drug | Vitamin E, 200 IU, Vitamin E, 400 IU, Vitamin E, 800 IU |
| PlaceboParticipants will take a placebo vitamin E capsule daily for 24 weeks | Drug | Placebo |
Primary outcome
Relative Change in Alanine Aminotransferase (ALT) From Baseline to 24 Weeks
Time frame: Baseline to 24 weeks (end of treatment)
Percent change from baseline to 24 weeks relative to baseline measure of ALT.
17 secondary outcomes
Proportion of Patients Achieving Normalization of Alanine Aminotransferase (ALT) at 24 Weeks
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Serum Alanine Aminotransferase (ALT) From Baseline
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Serum Aspartate Aminotransferase (AST) From Baseline
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Hepatic Steatosis (Fat in the Liver) Determined by Fibroscan® Controlled Attenuation Parameter (CAP) Software Function
Time frame: Baseline to24 weeks (end of treatment)
Mean Change in Liver Stiffness From Baseline Assessed by Fibroscan®
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Gamma-glutamyl Transferase (GGT) From Baseline to 24 Weeks
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Glucose From Baseline to 24 Weeks
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Weight From Baseline to 24 Weeks
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Body Mass Index (BMI) From Baseline to 24 Weeks
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Waist Circumference From Baseline to 24 Weeks
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Waist-to-hip Ratio From Baseline to 24 Weeks
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in Liver Symptom Questionnaire Total Score
Time frame: Baseline to 24 weeks (end of treatment)
Mean Change in ALT From 24 to 48 Weeks
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in AST From 24 to 48 Weeks
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in GGT From 24 to 48 Weeks
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in Controlled Attenuation Parameter (CAP) From 24 to 48 Weeks
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)
Mean Change in Liver Stiffness Measure (LSM) From 24 to 48 Weeks
Time frame: 24 weeks (end of treatment) to 48 weeks (final study visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Nonalcoholic Steatohepatitis Clinical Research Network CentersLink provided by the sponsor.
- The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. This study will comply with the 2013 NIH Data Sharing Policy. Results and information from this trial will be submitted to ClinicalTrials.gov and a public use database deposited with the NIDDK Central Repository within two years of the date that the database is locked for analysis (interventional studies, primary and secondary outcomes).
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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.
Arun Sanyal, MD principal investigator
Virginia Commonwealth University
9 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 Vitamin E in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 9 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 3 inclusion and 38 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Relative Change in Alanine Aminotransferase (ALT) From Baseline to 24 Weeks (time frame: Baseline to 24 weeks (end of treatment)). 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 14 May 2026.