Binge Eating DisorderVIDEO-DBT-GSHNCT07327203
Video-based Guided Self Help Dialectical Behavior Therapy for Binge Eating Disorder
A study testing Experimental: Video-based DBTgsh for BED and Traditional DBTgsh for BED (text-based model) in people with Binge Eating Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Dialectical Behavior Therapy (DBT) is an effective treatment for eating disorders, showing promising remission rates for Binge Eating Disorder (BED) in both standard and guided self-help formats. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Experimental: Video-based DBTgsh for BED and Traditional DBTgsh for BED (text-based model)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Feb 2026to 20 Dec 2026
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals diagnosed with binge eating disorder according to the DSM-5-TR.
- Access to a device with a camera, microphone, and internet connection.
- Minimum ability to read and write in Portuguese.
- Availability of 1 hour per week to read or watch treatment-related content.
- Participants with psychiatric comorbidities must be on a stable medication regimen for at least two months prior to enrollment in the study.
Who cannot join
- Individuals with anorexia nervosa or bulimia nervosa.
- Individuals with unstable psychiatric comorbidities (exclusion will apply to individuals who have experienced an acute psychiatric exacerbation requiring additional treatment or medical hospitalization.).
- Lack of time to read weekly chapters or watch the video lessons.
- Inability to access devices with a camera, microphone, and internet.
- Inability to attend six brief 30-minute videoconference sessions over the 13-week study period.
- Individuals at imminent risk to life (suicidal or self-harming behavior in the previous three months).
- Lack of minimum reading and writing skills.
Trial locations and contacts
1 site in 1 country.
About this study
Dialectical Behavior Therapy (DBT) is an effective treatment for eating disorders, showing promising remission rates for Binge Eating Disorder (BED) in both standard and guided self-help formats. Traditional guided self-help models typically combine weekly chapter readings with a limited number of brief therapist meetings. However, the requirement of weekly book readings can be particularly challenging for individuals with BED, who often exhibit impulsive personality traits, psychiatric comorbidities, and weight-related health problems.
This study was developed to test a version of guided self-help DBT-BED delivered through video lessons instead of text. This randomized clinical trial will be conducted at the Eating Disorders Program of the Institute of Psychiatry, Hospital das Clínicas, Faculty of Medicine, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil. Eighty adults with BED will be randomized to either an experimental group (weekly video lessons) or a control group (weekly text-based readings).
Both groups will undergo a 13-week intervention, including six brief 30-minute online guidance sessions with a psychologist. The primary outcome will be full remission from binge eating episodes at the end of treatment and at the 3-month follow-up. Secondary outcomes will include changes in eating disorder psychopathology, emotion regulation, quality of life, self-esteem, and dropout rates. Statistical analyses will follow the intention-to-treat principle.
Read the detailed description
The aim of this randomized controlled trial is to compare the efficacy of a video-based adaptation of guided self-help Dialectical Behavior Therapy for adults with Binge Eating Disorder (BED) with the traditional text-based guided self-help format. The study focuses on clinical remission of binge eating episodes, treatment adherence, and maintenance of therapeutic effects over time.
Eighty adults diagnosed with BED will be recruited through the Eating Disorders Program of the Institute of Psychiatry at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil. Participants will be randomly assigned to one of two intervention groups. The experimental group will receive the content of the guided self-help DBT-BED manual delivered through weekly video lessons based on the book chapters. The control group will receive the same content in a traditional text-based guided self-help format, following the same weekly structure.
Both groups will participate in six brief individual online guidance sessions with a psychologist, each lasting approximately 30 minutes. These sessions are intended to support treatment engagement, clarify intervention content, address treatment-interfering behaviors, promote generalization of DBT skills, and enhance motivation throughout the intervention.
Assessments will be conducted at baseline, at the end of the intervention period, and at a 3-month follow-up. The primary outcome of the study will be complete remission of binge eating episodes at post-treatment and follow-up. Secondary outcomes will include changes in eating disorder psychopathology, emotional regulation, quality of life, self-esteem, and treatment dropout rates.
The study is scheduled to begin in February 2026, with anticipated completion in December 2026.
- Conditions
- Binge Eating Disorder
- Being tested
- Experimental: Video-based DBTgsh for BED, Traditional DBTgsh for BED (text-based model)
- Keywords
- BED, DBT, Dialectical Behavior Therapy, Guided Self-Help, Video-based intervention, DBT-BED, DBTgsh
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Video-based DBTgsh for BEDBehavioural
This is a guided self-help behavioral intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly pre-recorded video lessons over 13 weeks. The intervention covers three core DBT skill modules-mindfulness, emotion regulation, and distress tolerance-and is supported by six brief 30-minute individual online guidance sessions with a psychologist to enhance adherence, clarify content, and support skill application.
Traditional DBTgsh for BED (text-based model)Behavioural
This is a guided self-help behavioral intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly chapter readings from a structured manual over 13 weeks. The intervention covers the same three core DBT skill modules-mindfulness, emotion regulation, and distress tolerance-and is supported by six brief 30-minute individual online guidance sessions with a psychologist to enhance adherence, clarify content, and support skill application.
| Study group | Role | What they receive |
|---|---|---|
| Video-based DBTgsh for BED | Experimental | Participants assigned to the experimental group will receive a 13-week guided self-help intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly video lessons. The content is structured into three progressive modules covering core DBT skills: (1) mindfulness, (2) emotion regulation, and (3) distress tolerance. The video lessons will be adapted from the Portuguese version of The DBT Solution for Emotional Eating (Safer, Adler \& Masson, 2020).
In addition to the video content, participants will have access to six brief online sessions with a psychologist (30 minutes each), conducted via videoconference. These sessions will be distributed as follows: two in the first two weeks, three biweekly, and one at the end of the treatment. Receives: Behavioral: Experimental: Video-based DBTgsh for BED |
| Traditional DBTgsh for BED (text-based model) | Active comparator | Participants in the control group will receive the traditional guided self-help version of DBT-BED, using the guided self-help manual of The DBT Solution for Emotional Eating in the Portuguese version (Safer, Adler \& Masson, 2020). Participants will be instructed to read one chapter per week over the 13-week treatment period. The content covers the same three core DBT modules: mindfulness skills, emotion regulation, and distress tolerance. As in the experimental group, participants will also participate in six online sessions with a psychologist (30 minutes each), following the same time schedule. These sessions will have the same objectives as those in the experimental group. Receives: Behavioral: Traditional DBTgsh for BED (text-based model) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination Questionnaire (EDE-Q)
Eating Disorder Examination Questionnaire (EDE-Q) is a self-report measure assessing the severity of eating disorder psychopathology, including binge eating-related symptoms. The global score is calculated as the mean of four subscales. Scores range from 0 to 6, with higher scores indicating greater eating disorder psychopathology.
Measured: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.
Secondary outcomes (3)
Difficulties in Emotion Regulation Scale (DERS)
Difficulties in Emotion Regulation Scale (DERS) is a self-report measure assessing difficulties across multiple aspects of emotional regulation, including emotional awareness, acceptance of emotional responses, impulse control, and access to effective emotion regulation strategies. The total score is calculated as the sum of 36 items. Scores range from 36 to 180, with higher scores indicating greater difficulties in emotion regulation.
Measured: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.
Short Form Health Survey (SF-36)
Short Form Health Survey (SF-36) is a generic self-report questionnaire assessing health-related quality of life across multiple domains, including physical functioning, role limitations due to physical or emotional problems, bodily pain, vitality, social functioning, emotional well-being, and general health perception. Scores range from 0 to 100, with higher scores indicating better perceived health status and fewer functional limitations.
Measured: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.
Rosenberg Self-Esteem Scale (RSES)
Rosenberg Self-Esteem Scale (RSES) is a self-report instrument designed to assess global self-esteem, reflecting overall feelings of self-worth and self-acceptance. The scale consists of 10 items rated on a Likert-type format, with the total score calculated as the sum of all items. Scores range from 0 to 30, with higher scores indicating higher levels of self-esteem.
Measured: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start2 Feb 2026
- Primary completion23 Oct 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Táki Athanássios Cordás, University of Sao Paulo General Hospital
- Investigators
- Táki Cordas, Medical Coordinator, Study director, Eating Disorders Program of the Psychiatry Institute, Hospital das Clínicas, Medical School, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327203
- Sponsor's protocol ID
- 88641125.1.0000.006
- Acronym
- VIDEO-DBT-GSH
- Status last verified
- Jun 2026
- First submitted
- 25 Dec 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the time of registration, a decision regarding the sharing of individual participant data (IPD) has not yet been made. The research team will evaluate the feasibility of IPD sharing after study completion, considering ethical approvals, participant consent, data protection regulations, and institutional policies. Any future data sharing will be limited to de-identified data and will follow applicable legal and ethical requirements.
Publications
Ben-Porath, D., Duthu, F., Luo, T., Gonidakis, F., Compte, E. J., & Wisniewski, L. (2020). Dialectical behavioral therapy: an update and review of the existing treatment models adapted for adults with eating disorders. Dialectical Behavior Therapy for Eating Disorders, 5-25. DOI: 10.1080/10640266.2020.1723371. Carter, J. C., Kenny, T. E., Singleton, C., Van Wijk, M., & Heath, O. (2020). Dialectical behavior therapy self-help for binge-eating disorder: A randomized controlled study. International Journal of Eating Disorders, 53(3), 451-460.Masson, P. C., von Ranson, K. M., Wallace, L. M., & Safer, D. L. (2013). A randomized wait-list controlled pilot study of dialectical behaviour therapy guided self-help for binge eating disorder. Behaviour research and therapy, 51(11), 723-728.Safer, D. L., Adler, S., & Masson, P. C. (2018). The DBT solution for emotional eating: A proven program to break the cycle of bingeing and out-of-control eating. Guilford Publications.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-based Guided Self Help Dialectical Behavior Therapy for Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT07327203
- Acronym / sponsor ID
- VIDEO-DBT-GSH / 88641125.1.0000.006
- Conditions
- Binge Eating Disorder
- Keywords
- BED, DBT, Dialectical Behavior Therapy, Guided Self-Help, Video-based intervention, DBT-BED, DBTgsh
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
Dialectical Behavior Therapy (DBT) is an effective treatment for eating disorders, showing promising remission rates for Binge Eating Disorder (BED) in both standard and guided self-help formats. Traditional guided self-help models typically combine weekly chapter readings with a limited number of brief therapist meetings. However, the requirement of weekly book readings can be particularly challenging for individuals with BED, who often exhibit impulsive personality traits, psychiatric comorbidities, and weight-related health problems.
This study was developed to test a version of guided self-help DBT-BED delivered through video lessons instead of text. This randomized clinical trial will be conducted at the Eating Disorders Program of the Institute of Psychiatry, Hospital das Clínicas, Faculty of Medicine, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil. Eighty adults with BED will be randomized to either an experimental group (weekly video lessons) or a control group (weekly text-based readings).
Both groups will undergo a 13-week intervention, including six brief 30-minute online guidance sessions with a psychologist. The primary outcome will be full remission from binge eating episodes at the end of treatment and at the 3-month follow-up. Secondary outcomes will include changes in eating disorder psychopathology, emotion regulation, quality of life, self-esteem, and dropout rates. Statistical analyses will follow the intention-to-treat principle.
Detailed description
The aim of this randomized controlled trial is to compare the efficacy of a video-based adaptation of guided self-help Dialectical Behavior Therapy for adults with Binge Eating Disorder (BED) with the traditional text-based guided self-help format. The study focuses on clinical remission of binge eating episodes, treatment adherence, and maintenance of therapeutic effects over time.
Eighty adults diagnosed with BED will be recruited through the Eating Disorders Program of the Institute of Psychiatry at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil. Participants will be randomly assigned to one of two intervention groups. The experimental group will receive the content of the guided self-help DBT-BED manual delivered through weekly video lessons based on the book chapters. The control group will receive the same content in a traditional text-based guided self-help format, following the same weekly structure.
Both groups will participate in six brief individual online guidance sessions with a psychologist, each lasting approximately 30 minutes. These sessions are intended to support treatment engagement, clarify intervention content, address treatment-interfering behaviors, promote generalization of DBT skills, and enhance motivation throughout the intervention.
Assessments will be conducted at baseline, at the end of the intervention period, and at a 3-month follow-up. The primary outcome of the study will be complete remission of binge eating episodes at post-treatment and follow-up. Secondary outcomes will include changes in eating disorder psychopathology, emotional regulation, quality of life, self-esteem, and treatment dropout rates.
The study is scheduled to begin in February 2026, with anticipated completion in December 2026.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based DBTgsh for BED | Experimental | Behavioral: Experimental: Video-based DBTgsh for BEDParticipants assigned to the experimental group will receive a 13-week guided self-help intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly video lessons. The content is structured into three progressive modules covering core DBT skills: (1) mindfulness, (2) emotion regulation, and (3) distress tolerance. The video lessons will be adapted from the Portuguese version of The DBT Solution for Emotional Eating (Safer, Adler \& Masson, 2020). In addition to the video content, participants will have access to six brief online sessions with a psychologist (30 minutes each), conducted via videoconference. These sessions will be distributed as follows: two in the first two weeks, three biweekly, and one at the end of the treatment. |
| Traditional DBTgsh for BED (text-based model) | Active comparator | Behavioral: Traditional DBTgsh for BED (text-based model)Participants in the control group will receive the traditional guided self-help version of DBT-BED, using the guided self-help manual of The DBT Solution for Emotional Eating in the Portuguese version (Safer, Adler \& Masson, 2020). Participants will be instructed to read one chapter per week over the 13-week treatment period. The content covers the same three core DBT modules: mindfulness skills, emotion regulation, and distress tolerance. As in the experimental group, participants will also participate in six online sessions with a psychologist (30 minutes each), following the same time schedule. These sessions will have the same objectives as those in the experimental group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals diagnosed with binge eating disorder according to the DSM-5-TR.
- Access to a device with a camera, microphone, and internet connection.
- Minimum ability to read and write in Portuguese.
- Availability of 1 hour per week to read or watch treatment-related content.
- Participants with psychiatric comorbidities must be on a stable medication regimen for at least two months prior to enrollment in the study.
Key exclusion criteria (7 listed)
- Individuals with anorexia nervosa or bulimia nervosa.
- Individuals with unstable psychiatric comorbidities (exclusion will apply to individuals who have experienced an acute psychiatric exacerbation requiring additional treatment or medical hospitalization.).
- Lack of time to read weekly chapters or watch the video lessons.
- Inability to access devices with a camera, microphone, and internet.
- Inability to attend six brief 30-minute videoconference sessions over the 13-week study period.
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 |
|---|---|---|
| Experimental: Video-based DBTgsh for BEDThis is a guided self-help behavioral intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly pre-recorded video lessons over 13 weeks. The intervention covers three core DBT skill modules-mindfulness, emotion regulation, and distress tolerance-and is supported by six brief 30-minute individual online guidance sessions with a psychologist to enhance adherence, clarify content, and support skill application. | Behavioural | Video-based DBTgsh for BED |
| Traditional DBTgsh for BED (text-based model)This is a guided self-help behavioral intervention based on Dialectical Behavior Therapy for Binge Eating Disorder (DBT-BED), delivered through weekly chapter readings from a structured manual over 13 weeks. The intervention covers the same three core DBT skill modules-mindfulness, emotion regulation, and distress tolerance-and is supported by six brief 30-minute individual online guidance sessions with a psychologist to enhance adherence, clarify content, and support skill application. | Behavioural | Traditional DBTgsh for BED (text-based model) |
Primary outcome
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.
Eating Disorder Examination Questionnaire (EDE-Q) is a self-report measure assessing the severity of eating disorder psychopathology, including binge eating-related symptoms. The global score is calculated as the mean of four subscales. Scores range from 0 to 6, with higher scores indicating greater eating disorder psychopathology.
3 secondary outcomes
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.
Short Form Health Survey (SF-36)
Time frame: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.
Rosenberg Self-Esteem Scale (RSES)
Time frame: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.
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 3 Jun 2026.
- BackgroundBen-Porath, D., Duthu, F., Luo, T., Gonidakis, F., Compte, E. J., & Wisniewski, L. (2020). Dialectical behavioral therapy: an update and review of the existing treatment models adapted for adults with eating disorders. Dialectical Behavior Therapy for Eating Disorders, 5-25. DOI: 10.1080/10640266.2020.1723371. Carter, J. C., Kenny, T. E., Singleton, C., Van Wijk, M., & Heath, O. (2020). Dialectical behavior therapy self-help for binge-eating disorder: A randomized controlled study. International Journal of Eating Disorders, 53(3), 451-460.Masson, P. C., von Ranson, K. M., Wallace, L. M., & Safer, D. L. (2013). A randomized wait-list controlled pilot study of dialectical behaviour therapy guided self-help for binge eating disorder. Behaviour research and therapy, 51(11), 723-728.Safer, D. L., Adler, S., & Masson, P. C. (2018). The DBT solution for emotional eating: A proven program to break the cycle of bingeing and out-of-control eating. Guilford Publications.
- Individual participant dataSharing planned: Undecided. At the time of registration, a decision regarding the sharing of individual participant data (IPD) has not yet been made. The research team will evaluate the feasibility of IPD sharing after study completion, considering ethical approvals, participant consent, data protection regulations, and institutional policies. Any future data sharing will be limited to de-identified data and will follow applicable legal and ethical requirements.
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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.
Táki Cordas, Medical Coordinator study director
Eating Disorders Program of the Psychiatry Institute, Hospital das Clínicas, Medical School, University of São Paulo (AMBULIM IPq HC FMUSP), Brazil.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Video-based DBTgsh for BED and Traditional DBTgsh for BED (text-based model) in people with Binge Eating Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. 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 Brazil. 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.
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?
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?
Eating Disorder Examination Questionnaire (EDE-Q) (time frame: Pre-treatment (baseline), post-treatment at 13 weeks, and 3-month follow-up.). 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 NCT07327203, which also lists 1 linked publication.
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 3 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.