Breast CancerPhase 2A-NEWNCT04499950
Adaptive Nutrition and Exercise Weight Loss (A-NEW) Study
A Phase 2 study testing Contrave and Behavioral Weight Loss in people with Breast Cancer and Overweight or Obesity, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Overweight or Obesity
- What is being tested?
- Contrave and Behavioral Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 10 Jan 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, at least 3 months after completion of local therapy (e.g. surgery, radiation), and if applicable, adjuvant chemotherapy
- Diagnosed within 10 years with histologically-confirmed ductal carcinoma in situ (DCIS) or stage I-III invasive carcinoma of the breast
- Up to date with recommended screening mammography within one year
- Current BMI ≥ 30 kg/m2 or BMI 27.0-29.9 kg/m2 with hypertension, non-insulin dependent diabetes or hyperlipidemia; and weight ≤ 400 lbs
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Willingness to change diet, physical activity, track behaviors, engage in weekly and monthly contacts and visit, and take chronic weight loss medication
- Able to read and write the English language without assistance and daily access to the e-mail and/or smartphone
- Patient is aware of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Who cannot join
- Serious/uncontrolled medical condition at the discretion of the Protocol Chair/designee likely to hinder accurate measurement of weight or any condition for which weight loss is contraindicated or would affect adipokine and inflammatory markers (e.g. active malignancy, end stage renal disease on dialysis, cirrhosis, autoimmune disease, adrenal disease, uncontrolled hypertension, seizure disorder, and history of bariatric surgery)
- Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
- Currently enrolled or planning to enroll in a weight loss program (e.g. Weight Watchers, Jenny Craig, Nutrisystem and Medifast) or to take a chronic weight loss medication.
- Diabetes on insulin or sulfonylureas within the past 3 months
- Unstable psychiatric disorder or bulimia/anorexia nervosa
- Alcohol, nicotine or substance abuse; or undergoing abrupt discontinuation of alcohol, benzodiazepine, barbiturate or anti-epileptic drug
Show all 13Show fewer
- Use of the following medications are excluded:
- Monoamine oxidase (MAO) inhibitors (must be >14 days from discontinuation)
- Thyroid medication use unless on stable doses for at least the past 3 months
- Buproprion containing products or opiate agonists (must be >14 days from discontinuation)
- Medications that cause weight loss (e.g., lorcaserin, phentermine, orlistat, Qsymia, Contrave) within the past 3 months
- Medications that are likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine, oral contraceptive pills, hormone replacement therapy) within the past 3 months. NOTE: An exception to this is that SSRI's and SNRI's are allowed if participant has been on stable doses for at least 3 months (if discontinued, a washout of 2 weeks from prior selective serotonin reuptake inhibitor (SSRI)/Serotonin-norepinephrine reuptake inhibitor (SNRI) use is required).
- Medications that may affect adipokine or inflammatory markers (e.g., metformin, glitazones, steroids, angiotensin converting enzyme (ACE) inhibitors, beta blockers and statins) unless on stable doses ≥3 months prior to registration (if discontinued, a washout of 2 weeks from prior use is required). Concurrent NSAIDs are allowed if use is limited to <3 times per week; chronic NSAIDs are permitted on study only if use has been ≥3 times per week for at least 3 months prior to registration and is expected to continue.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
Official title: A Phase II Single Arm Adaptive Weight Loss Study in Women With Early Stage Breast Cancer
This is a single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome.
Read the detailed description
The investigators will evaluate the extent to which implementation of a chronic weight loss medication, Contrave® (Naltrexone/Bupropion), is associated with achieving ≥5% weight loss. All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) while those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave (as per Federal Drug Administration [FDA] recommended administration) starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. During month 3, all participants continue to have weekly calls with the behavioral coach and will be asked about symptoms, which may be related to initiation of pharmacotherapy; any symptoms are reported to the PI for further evaluation. In addition to total weight loss, the investigators will evaluate biomarkers associated with obesity, microbiome and cardiometabolic factors.
- Conditions
- Breast Cancer, Overweight or Obesity
- Being tested
- Contrave, Behavioral Weight Loss
- Medical subject headings
- Breast Neoplasms, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ContraveDrug
Also called Naltrexone/Bupropion
Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6.
Behavioral Weight LossBehavioural
6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.
| Study group | Role | What they receive |
|---|---|---|
| SLOW-BWL | Experimental | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. Receives: Drug: Contrave; Behavioral: Behavioral Weight Loss |
| FAST-BWL | Active comparator | All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) Receives: Behavioral: Behavioral Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With 5 Percent Weight Loss (in SLOW-BWL)
To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9.
Measured: 6 months
Secondary outcomes (7)
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function. The total score ranges from 33.5 to 61.7. The higher the score, the better the physical function.
Measured: Baseline, 2 months and 6 Months
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference. The total score ranges from 41.0-67.4. The lower the score, the better the pain interference.
Measured: Baseline, 2 months and 6 Months
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue. The total score ranges from 39.6 to 62.0. The lower the score, the less the fatigue.
Measured: Baseline, 2 months and 6 Months
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Depression. The total score ranges from 37.1-71.4. The lower the score, the less depression.
Measured: Baseline, 2 months and 6 Months
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety. Scores range 36.3-71.5, with higher scores representing more severe anxiety symptoms.
Measured: Baseline, 2 months and 6 Months
Change in Scores on the Medical Outcomes Study (MOS) Sexual Functioning Scale Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Medical Outcomes Study (MOS) Sexual Function. Score range 0-100 with higher score indicating less functioning.
Four items are rated on a 5-point scale (1=not a problem, 2=little of a problem, 3=somewhat of a problem, 4=very much of a problem, and 5=not applicable).
Measured: Baseline, 2 months and 6 Months
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
To report the change in scores at 2 and 6 months to baseline among FAST-BWL vs SLOW-BWL arms for Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES). Scores ranging from 39.0 to 73.0. Higher scores indicate greater impact from symptoms.
Measured: Baseline, 2 months and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start8 Feb 2021
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
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 Breast CancerStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- American Institute for Cancer Research, Breast Cancer Research Foundation, Hopkins-WellSpan Cancer Research Fund
- Responsible party
- Sponsor
- Investigators
- Jennifer Sheng, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499950
- Sponsor's protocol ID
- IRB00223131
- Acronym
- A-NEW
- Status last verified
- Jan 2025
- First submitted
- 31 Jul 2020
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single Arm Adaptive Weight Loss Study in Women With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04499950
- Acronym / sponsor ID
- A-NEW / IRB00223131
- Conditions
- Breast Cancer, Overweight or Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- American Institute for Cancer Research, Breast Cancer Research Foundation, Hopkins-WellSpan Cancer Research Fund
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Posted 6 Mar 2025
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 single arm phase II study designed to determine the effects of pharmacotherapy and a remote behavioral weight loss intervention on weight loss in breast cancer survivors who are overweight or obese, and the impact of successful weight loss on serum biomarkers and gut microbiome.
Detailed description
The investigators will evaluate the extent to which implementation of a chronic weight loss medication, Contrave® (Naltrexone/Bupropion), is associated with achieving ≥5% weight loss. All patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) while those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave (as per Federal Drug Administration [FDA] recommended administration) starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. During month 3, all participants continue to have weekly calls with the behavioral coach and will be asked about symptoms, which may be related to initiation of pharmacotherapy; any symptoms are reported to the PI for further evaluation. In addition to total weight loss, the investigators will evaluate biomarkers associated with obesity, microbiome and cardiometabolic factors.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLOW-BWL | Experimental | Drug: Contrave, Behavioral: Behavioral Weight LossAll patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose <5%, designated slow responders, will continue BWL and initiate Contrave (SLOW-BWL). The SLOW-BWL arm will receive at least 16 weeks of Contrave [as per the Food and Drug Administration (FDA) recommended administration] starting at week 9 and discontinue if ≥5% weight loss is not achieved at month 6. |
| FAST-BWL | Active comparator | Behavioral: Behavioral Weight LossAll patients will receive the POWER-remote behavioral weight loss intervention (BWL) and have a behavioral coach for the duration of the 6 month study. During months 1-3, the behavioral coach will call weekly. From months 4-6, the behavioral coach will call monthly. At week 9, those who lose ≥5%, designated fast responders, will continue with BWL alone (FAST-BWL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female, at least 3 months after completion of local therapy (e.g. surgery, radiation), and if applicable, adjuvant chemotherapy
- Diagnosed within 10 years with histologically-confirmed ductal carcinoma in situ (DCIS) or stage I-III invasive carcinoma of the breast
- Up to date with recommended screening mammography within one year
- Current BMI ≥ 30 kg/m2 or BMI 27.0-29.9 kg/m2 with hypertension, non-insulin dependent diabetes or hyperlipidemia; and weight ≤ 400 lbs
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (13 listed)
- Serious/uncontrolled medical condition at the discretion of the Protocol Chair/designee likely to hinder accurate measurement of weight or any condition for which weight loss is contraindicated or would affect adipokine and inflammatory markers (e.g. active malignancy, end stage renal disease on dialysis, cirrhosis, autoimmune disease, adrenal disease, uncontrolled hypertension, seizure disorder, and history of bariatric surgery)
- Pregnant or nursing within past 6 months, or plans to become pregnant in the next year
- Currently enrolled or planning to enroll in a weight loss program (e.g. Weight Watchers, Jenny Craig, Nutrisystem and Medifast) or to take a chronic weight loss medication.
- Diabetes on insulin or sulfonylureas within the past 3 months
- Unstable psychiatric disorder or bulimia/anorexia nervosa
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 |
|---|---|---|
| ContraveAlso: Naltrexone/BupropionInitiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6. | Drug | SLOW-BWL |
| Behavioral Weight Loss6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6. | Behavioural | FAST-BWL, SLOW-BWL |
Primary outcome
Number of Patients With 5 Percent Weight Loss (in SLOW-BWL)
Time frame: 6 months
To assess the rate of SLOW-BWL patients attaining at least 5% weight loss of their baseline body weight at 6 months with the addition of Contrave to BWL at week 9.
7 secondary outcomes
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
Time frame: Baseline, 2 months and 6 Months
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
Time frame: Baseline, 2 months and 6 Months
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form Questionnaire Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
Time frame: Baseline, 2 months and 6 Months
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
Time frame: Baseline, 2 months and 6 Months
Change in Scores on Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety - Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
Time frame: Baseline, 2 months and 6 Months
Change in Scores on the Medical Outcomes Study (MOS) Sexual Functioning Scale Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
Time frame: Baseline, 2 months and 6 Months
Change in Scores on Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Among FAST-BWL vs SLOW-BWL, as Well as Participants Who Achieve ≥5% Weight Loss at 6 Months vs Those Who Are Unable to
Time frame: Baseline, 2 months and 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jennifer Sheng principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contrave and Behavioral Weight Loss in people with Breast Cancer and Overweight or Obesity, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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 8 inclusion and 13 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 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 6 Mar 2025). 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?
Number of Patients With 5 Percent Weight Loss (in SLOW-BWL) (time frame: 6 months). 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 6 Mar 2025.