Type 1 DiabetesPhase 2NCT06455319
Precision Administration of Anti-thymocyte Globulin With or Without Verapamil
A Phase 2 study testing Anti-thymocyte globulin (ATG) and verapamil extended release capsule in people with Type 1 Diabetes, run by University of Florida at 2 sites in United States.
Trial summary
T cell directed therapy, anti-thymocyte globulin (ATG), in low doses, has been shown to lower HbA1c and preserve endogenous insulin production (measured by C-peptide) in individuals with recently diagnosed type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 6 to 35 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Anti-thymocyte globulin (ATG) and verapamil extended release capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Nov 2025to Aug 2030
- 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 6 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must be >= 6 years <= 35
- Must have a diagnosis of T1D for less than 100 days at randomization
- Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is <18 years of age
- Positive for at least one islet cell autoantibody; GAD65A, mIAA, if obtained within 10 days of the onset of insulin therapy, IA-2A, ICA, or ZnT8A
- Must have stimulated C-peptide levels of 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes. Randomization should occur within one month (37 days) of the MMTT.
- Subjects who are EBV seronegative at screening must be EBV PCR negative within 30 days of randomization and may not have had signs or symptoms of an EBV compatible illness lasting longer than 7 days within 30 days of randomization
Show all 10Show fewer
- Be at least 6 weeks from last live immunization
- Participants are required to receive killed influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available
- Be willing to forgo live vaccines during the treatment period and for 3 months following last dose of study drug
- Be willing to comply with intensive diabetes management
Who cannot join
- Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (< 3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800 lymphocytes/μL), or thrombocytopenia (<100,000 platelets/μL).
- Have active signs or symptoms of acute infection at the time of randomization
- Have evidence of prior or current tuberculosis infection as assessed by PPD, interferon gamma release assay or by history
- Be currently pregnant or lactating, or anticipate getting pregnant within the two year study period
- Require use of other immunosuppressive agents including chronic use of systemic steroids
- Have evidence of current or past HIV, Hepatitis B or Hepatitis C infection
Show all 17Show fewer
- Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, COPD, sickle cell disease, neurological, or blood count abnormalities
- Have a history of malignancies other than skin
- Evidence of liver dysfunction with AST or ALT greater than 3 times the upper limits of normal
- Evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
- Vaccination with a live virus within the last 6 weeks
- Current or ongoing use of non-insulin pharmaceuticals that affect glycemic control within prior 7 days of screening
- Active participation in another T1D treatment study in the previous 30 days
- Prior treatment with any investigational agent to delay beta cell loss in T1D
- Known allergy to ATG or Verapamil
- Prior treatment with ATG, Verapamil or known allergy to rabbit derived products
- Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Kimber Simmons, MD, 303-724-1055, kimber.simmons@cuanschutz.edu
- Recruiting
University of Florida
Gainesville, Florida, 32610
Jennifer L Hosford, MPH, 352-294-5760, jennifer.hosford@peds.ufl.edu
Laura M Jacobsen, MD
About this study
Official title: Precision Administration of Anti-thymocyte Globulin With or Without Verapamil in Adolescents and Young Adults With Type 1 Diabetes
T cell directed therapy, anti-thymocyte globulin (ATG), in low doses, has been shown to lower HbA1c and preserve endogenous insulin production (measured by C-peptide) in individuals with recently diagnosed type 1 diabetes (T1D). However, not all individuals who received ATG responded to the therapy (i.e., non-responders). Additionally, use of ATG alone does not address inherent beta cell stress. A calcium channel blocker, verapamil, has demonstrated C-peptide preservation in newly diagnosed T1D. Investigators will identify those mostly likely to respond to ATG using an ex vivo predictive biomarker of response to ATG. In addition, Investigators will use sequential therapies to increase efficacy (ATG followed by verapamil) and explore synergistic mechanisms. This will be assessing with in depth immunophenotyping and quantify biomarkers of beta cell stress, cell death, and abnormal prohormone processing. Finally, novel clinical trial endpoints will be assessed for their ability to predict treatment efficacy earlier than the standard endpoint at 1 year.
Read the detailed description
Investigators will conduct a phase 2 1:1 randomized controlled and blinded trial in Aim 1 comparing stimulated C-peptide (and other measures) between those treated with low-dose ATG and those treated with placebo. Co-primary endpoints include the difference between mean ATG and placebo values of the 2-hr mixed meal tolerance test (MMTT)-stimulated area under the curve (AUC) C-peptide at 12 months (standard T1D trial measure) and the difference between the change in the same measure over the first 6 months. Participants will be stratified based on their ex vivo immune responder signature to allow an equal number of "responders" and "non-responders" in both treatment arms. Following each participant's completion of this 1 year randomized controlled trial (RCT) they will enter Aim 2 and be re-randomized to received verapamil or not in an open-label 1 year extension where mechanistic endpoints will be explored related to immunophenotyping, gene expression, DNA methylation and beta cell markers including markers of beta cell stress and death as well as markers of abnormal prohormone processing.
- Conditions
- Type 1 Diabetes
- Being tested
- Anti-thymocyte globulin (ATG), verapamil extended release capsule, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-thymocyte globulin (ATG)Drug
Also called Thymoglobulin
ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2).
verapamil extended release capsuleDrug
Also called Calan, Isoptin
Open label administration at 120, 240 or 360 mg daily based on weight and ECG findings
PlaceboDrug
I.V. Saline
| Study group | Role | What they receive |
|---|---|---|
| Anti-thymocyte globulin (ATG) intravenous infusion | Experimental | ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2). Receives: Drug: Anti-thymocyte globulin (ATG) |
| Placebo-ATG | Placebo comparator | Saline placebo Receives: Drug: Placebo |
| verapamil extended release capsule | Experimental | Open label administration at 120, 240 or 360 mg daily based on weight and ECG findings Receives: Drug: verapamil extended release capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC C-peptide between ATG and placebo values
mean difference between ATG and placebo values of the 2-hr mixed meal tolerance test (MMTT)-stimulated area under the curve (AUC) C-peptide at 12 months
Measured: 12 Months
Change in 2-hr MMTT AUC C-peptide
mean difference between the change in 2-hr MMTT stimulated AUC C-peptide
Measured: 6 months
Secondary outcomes (1)
Immune and beta cell mechanistic analyses
To explore mechanisms of synergy between ATG received in year 1 and the addition of open-label verapamil in year 2.
Measured: 6, 12, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start12 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2). Verapamil extended release capsule will be given via open label administration at 120, 240 or 360 mg daily based on weight and echocardiogram (ECG) findings
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, University of Miami
- Responsible party
- Sponsor
- Investigators
- Laura M Jacobsen, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455319
- Sponsor's protocol ID
- IRB202400422
- Status last verified
- Nov 2025
- First submitted
- 3 Jun 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: resources generated by this proposal will be made available to the general scientific community through publication in peer-reviewed journals and presentation at national/international meetings. Genomic data in the form of transcriptomic, epigenomic, and gene expression data will be generated. This proposal includes \< 60 human samples. Nonetheless, I will prepare the data for submission to appropriate public repositories. These include 1) the National Center for Biotechnology Information (NCBI, https://www.ncbi.nlm.nih.gov/) Gene Expression Omnibus (GEO, http://www.ncbi.nlm.nih.gov/geo) for functional genomic data, 2) Encyclopedia of DNA Elements (ENCODE) for transcriptional and epigenetic data, and 3) immuneACCESS (https://clients.adaptivebiotech.com/immuneaccess) for immune repertoire data. I will follow the standardization of these organizations to provide valuable data allowing for reproducible results following the FAIR principles (Findable, Accessible, Interoperable, Reusable).
Publications
Haller MJ, Schatz DA, Skyler JS, Krischer JP, Bundy BN, Miller JL, Atkinson MA, Becker DJ, Baidal D, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Herold KC, Marks JB, Moran A, Rodriguez H, Russell W, Wilson DM, Greenbaum CJ; Type 1 Diabetes TrialNet ATG-GCSF Study Group. Low-Dose Anti-Thymocyte Globulin (ATG) Preserves beta-Cell Function and Improves HbA1c in New-Onset Type 1 Diabetes. Diabetes Care. 2018 Sep;41(9):1917-1925. doi: 10.2337/dc18-0494. Epub 2018 Jul 16.
PubMed 30012675Foster TP, Jacobsen LM, Bruggeman B, Salmon C, Hosford J, Chen A, Cintron M, Mathews CE, Wasserfall C, Brusko MA, Brusko TM, Atkinson MA, Schatz DA, Haller MJ. Low-Dose Antithymocyte Globulin: A Pragmatic Approach to Treating Stage 2 Type 1 Diabetes. Diabetes Care. 2024 Feb 1;47(2):285-289. doi: 10.2337/dc23-1750.
PubMed 38117469Lin A, Mack JA, Bruggeman B, Jacobsen LM, Posgai AL, Wasserfall CH, Brusko TM, Atkinson MA, Gitelman SE, Gottlieb PA, Gurka MJ, Mathews CE, Schatz DA, Haller MJ. Low-Dose ATG/GCSF in Established Type 1 Diabetes: A Five-Year Follow-up Report. Diabetes. 2021 May;70(5):1123-1129. doi: 10.2337/db20-1103. Epub 2021 Feb 25.
PubMed 33632742Ovalle F, Grimes T, Xu G, Patel AJ, Grayson TB, Thielen LA, Li P, Shalev A. Verapamil and beta cell function in adults with recent-onset type 1 diabetes. Nat Med. 2018 Aug;24(8):1108-1112. doi: 10.1038/s41591-018-0089-4. Epub 2018 Jul 9.
PubMed 29988125
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Administration of Anti-thymocyte Globulin With or Without Verapamil in Adolescents and Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06455319
- Acronym / sponsor ID
- IRB202400422
- Conditions
- Type 1 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of Miami
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 12 Jun 2024 (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.
T cell directed therapy, anti-thymocyte globulin (ATG), in low doses, has been shown to lower HbA1c and preserve endogenous insulin production (measured by C-peptide) in individuals with recently diagnosed type 1 diabetes (T1D). However, not all individuals who received ATG responded to the therapy (i.e., non-responders). Additionally, use of ATG alone does not address inherent beta cell stress. A calcium channel blocker, verapamil, has demonstrated C-peptide preservation in newly diagnosed T1D. Investigators will identify those mostly likely to respond to ATG using an ex vivo predictive biomarker of response to ATG. In addition, Investigators will use sequential therapies to increase efficacy (ATG followed by verapamil) and explore synergistic mechanisms. This will be assessing with in depth immunophenotyping and quantify biomarkers of beta cell stress, cell death, and abnormal prohormone processing. Finally, novel clinical trial endpoints will be assessed for their ability to predict treatment efficacy earlier than the standard endpoint at 1 year.
Detailed description
Investigators will conduct a phase 2 1:1 randomized controlled and blinded trial in Aim 1 comparing stimulated C-peptide (and other measures) between those treated with low-dose ATG and those treated with placebo. Co-primary endpoints include the difference between mean ATG and placebo values of the 2-hr mixed meal tolerance test (MMTT)-stimulated area under the curve (AUC) C-peptide at 12 months (standard T1D trial measure) and the difference between the change in the same measure over the first 6 months. Participants will be stratified based on their ex vivo immune responder signature to allow an equal number of "responders" and "non-responders" in both treatment arms. Following each participant's completion of this 1 year randomized controlled trial (RCT) they will enter Aim 2 and be re-randomized to received verapamil or not in an open-label 1 year extension where mechanistic endpoints will be explored related to immunophenotyping, gene expression, DNA methylation and beta cell markers including markers of beta cell stress and death as well as markers of abnormal prohormone processing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2). Verapamil extended release capsule will be given via open label administration at 120, 240 or 360 mg daily based on weight and echocardiogram (ECG) findings
| Arm | Type | Receives |
|---|---|---|
| Anti-thymocyte globulin (ATG) intravenous infusion | Experimental | Drug: Anti-thymocyte globulin (ATG)ATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2). |
| Placebo-ATG | Placebo comparator | Drug: PlaceboSaline placebo |
| verapamil extended release capsule | Experimental | Drug: verapamil extended release capsuleOpen label administration at 120, 240 or 360 mg daily based on weight and ECG findings |
Who may qualify
- Ages
- 6 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Must be >= 6 years <= 35
- Must have a diagnosis of T1D for less than 100 days at randomization
- Willing to provide Informed Consent or have a parent or legal guardian provide informed consent if the subject is <18 years of age
- Positive for at least one islet cell autoantibody; GAD65A, mIAA, if obtained within 10 days of the onset of insulin therapy, IA-2A, ICA, or ZnT8A
- Must have stimulated C-peptide levels of 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes. Randomization should occur within one month (37 days) of the MMTT.
Key exclusion criteria (17 listed)
- Be immunodeficient or have clinically significant chronic lymphopenia: (Leukopenia (< 3,000 leukocytes /μL), neutropenia (<1,500 neutrophils/μL), lymphopenia (<800 lymphocytes/μL), or thrombocytopenia (<100,000 platelets/μL).
- Have active signs or symptoms of acute infection at the time of randomization
- Have evidence of prior or current tuberculosis infection as assessed by PPD, interferon gamma release assay or by history
- Be currently pregnant or lactating, or anticipate getting pregnant within the two year study period
- Require use of other immunosuppressive agents including chronic use of systemic steroids
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 |
|---|---|---|
| Anti-thymocyte globulin (ATG)Also: ThymoglobulinATG (brand name Thymoglobulin) a polyclonal T cell antibody preparation. It will be given at low doses (0.5 mg/kg Day 1 then 2 mg/kg Day 2). | Drug | Anti-thymocyte globulin (ATG) intravenous infusion |
| verapamil extended release capsuleAlso: Calan, IsoptinOpen label administration at 120, 240 or 360 mg daily based on weight and ECG findings | Drug | verapamil extended release capsule |
| PlaceboI.V. Saline | Drug | Placebo-ATG |
Primary outcome
AUC C-peptide between ATG and placebo values
Time frame: 12 Months
mean difference between ATG and placebo values of the 2-hr mixed meal tolerance test (MMTT)-stimulated area under the curve (AUC) C-peptide at 12 months
Change in 2-hr MMTT AUC C-peptide
Time frame: 6 months
mean difference between the change in 2-hr MMTT stimulated AUC C-peptide
1 secondary outcome
Immune and beta cell mechanistic analyses
Time frame: 6, 12, 18, 24 months
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 26 Nov 2025.
- Results publication: PubMed 30012675Haller MJ, Schatz DA, Skyler JS, Krischer JP, Bundy BN, Miller JL, Atkinson MA, Becker DJ, Baidal D, DiMeglio LA, Gitelman SE, Goland R, Gottlieb PA, Herold KC, Marks JB, Moran A, Rodriguez H, Russell W, Wilson DM, Greenbaum CJ; Type 1 Diabetes TrialNet ATG-GCSF Study Group. Low-Dose Anti-Thymocyte Globulin (ATG) Preserves beta-Cell Function and Improves HbA1c in New-Onset Type 1 Diabetes. Diabetes Care. 2018 Sep;41(9):1917-1925. doi: 10.2337/dc18-0494. Epub 2018 Jul 16.
- Results publication: PubMed 38117469Foster TP, Jacobsen LM, Bruggeman B, Salmon C, Hosford J, Chen A, Cintron M, Mathews CE, Wasserfall C, Brusko MA, Brusko TM, Atkinson MA, Schatz DA, Haller MJ. Low-Dose Antithymocyte Globulin: A Pragmatic Approach to Treating Stage 2 Type 1 Diabetes. Diabetes Care. 2024 Feb 1;47(2):285-289. doi: 10.2337/dc23-1750.
- Results publication: PubMed 33632742Lin A, Mack JA, Bruggeman B, Jacobsen LM, Posgai AL, Wasserfall CH, Brusko TM, Atkinson MA, Gitelman SE, Gottlieb PA, Gurka MJ, Mathews CE, Schatz DA, Haller MJ. Low-Dose ATG/GCSF in Established Type 1 Diabetes: A Five-Year Follow-up Report. Diabetes. 2021 May;70(5):1123-1129. doi: 10.2337/db20-1103. Epub 2021 Feb 25.
- Results publication: PubMed 29988125Ovalle F, Grimes T, Xu G, Patel AJ, Grayson TB, Thielen LA, Li P, Shalev A. Verapamil and beta cell function in adults with recent-onset type 1 diabetes. Nat Med. 2018 Aug;24(8):1108-1112. doi: 10.1038/s41591-018-0089-4. Epub 2018 Jul 9.
- Individual participant dataSharing planned: No. resources generated by this proposal will be made available to the general scientific community through publication in peer-reviewed journals and presentation at national/international meetings. Genomic data in the form of transcriptomic, epigenomic, and gene expression data will be generated. This proposal includes < 60 human samples. Nonetheless, I will prepare the data for submission to appropriate public repositories. These include 1) the National Center for Biotechnology Information (NCBI, https://www.ncbi.nlm.nih.gov/) Gene Expression Omnibus (GEO, http://www.ncbi.nlm.nih.gov/geo) for functional genomic data, 2) Encyclopedia of DNA Elements (ENCODE) for transcriptional and epigenetic data, and 3) immuneACCESS (https://clients.adaptivebiotech.com/immuneaccess) for immune repertoire data. I will follow the standardization of these organizations to provide valuable data allowing for reproducible results following the FAIR principles (Findable, Accessible, Interoperable, Reusable).
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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.
Laura M Jacobsen, MD principal investigator
University of Florida
2 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 Anti-thymocyte globulin (ATG) and verapamil extended release capsule in people with Type 1 Diabetes, run by University of Florida at 2 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 10 inclusion and 17 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 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Jennifer L Hosford, MPH (352-294-5760, jennifer.hosford@peds.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC C-peptide between ATG and placebo values (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06455319, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.