Latent Autoimmune Diabetes in AdultsPhase 2GADinLADANCT04262479
Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes
A Phase 2 study testing recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel and Vitamin D in people with Latent Autoimmune Diabetes in Adults, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
Trial summary
This study will evaluate the effects of 3 intra-nodal injections of GAD-alum (Diamyd), together with oral vitamin D supplementation. Safety and feasibility of the treatment will be evaluated and also effects on the immune system and on the preservation of endogenous insulin production. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Latent Autoimmune Diabetes in Adults
- What is being tested?
- recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel and Vitamin D
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Mar 2020to 5 May 2022
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent by the patient.
- Diagnosis of LADA and diabetes debut within the last 18 months before inclusion. LADA should be defined by the criteria of age ≥30 years at the onset of diabetes, anti-GAD positivity and no clinical need for permanent insulin treatment during the first 3 months after the diagnosis of diabetes.
- Fasting C-peptid levels ≥ 0.3 nmol/l
- High GADA titers (>190 U/ml)
- Patients must be insulin independent at baseline by clinical judgement and C-peptide criteria
- Antidiabetic medication in the form of metformin is acceptable for inclusion as well as medications not mentioned under exclusion criteria
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- Females must agree to avoid pregnancy, and must have a negative urine pregnancy test.
- Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of GAD-alum. Adequate contraception is as follows:
- For females of childbearing potential:
- oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
- combined (estrogen and progestogen containing)
- oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation
- intrauterine device
- intrauterine hormone-releasing system (for example, progestin-releasing coil)
- bilateral tubal occlusion
- vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
- male partner using condom
- abstinence from heterosexual intercourse
- For males of childbearing potential:
- condom (male)
- abstinence from heterosexual intercourse
Who cannot join
- Current or previous treatment with immunosuppressant therapy (topical or inhaled steroids are accepted)
- Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- Systemic treatment with glucocorticoids
- Treatment with any vaccine, including influenza vaccine, within 1 month prior to planned first study drug dose or planned treatment with any vaccine up to 1 month after the last injection with study drug
- Antidiabetic medication (metformin excepted)
- Significantly abnormal hematology results at screening (i.e. anemia with hemoglobin < 12 g/L).
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- A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
- Clinically significant history of acute reaction to vaccines in the past.
- Renal disease (as defined by serum creatinine >150 µmol/l)
- Serious cardiovascular events (myocardial infarction, stroke) within the last year preceding recruitment.
- Participation in other clinical trials with a new chemical entity within the previous 3 months
- A history of alcohol or drug abuse
- Known HIV or hepatitis
- Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
- Other serious chronic disease as judged by investigator.
- Females who are lactating, are pregnant or intend to become pregnant.
- Inability or unwillingness to comply with the provisions of this protocol
- Deemed by the investigator not being able to follow instructions and/or follow the study protocol
- Treatment any other supplementation of with vitamin D, marketed or not, or unwilling to abstain from such medication during the trial 120 days daily intake of Divisun (non-investigational medicinal product)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Sweden1 site
Akademiskt Specialistcentrum, Centrum for Diabetes, and Karolinska Institute
Stockholm
About this study
Official title: A Pilot Study on Safety, Feasibility and Insulin-promotion by Intra-inguinal Lymph Node Injections of Glutamic Acid Decarboxylase (GAD) in Patients With LADA Type of Diabetes
This study will evaluate the effects of 3 intra-nodal injections of GAD-alum (Diamyd), together with oral vitamin D supplementation. Safety and feasibility of the treatment will be evaluated and also effects on the immune system and on the preservation of endogenous insulin production.
Read the detailed description
The purpose of the trial is to evaluate the effects of 3 intra-nodal injections of GAD-alum, together with oral vitamin D supplementation, in a population of LADA patients with high GADA titers. Effects will be summarized at 5 and 12 months after the first injection.
- The primary objective is to evaluate safety and feasibility of this treatment regimen.
- Secondary objectives are to test if the treatment induces a strong GAD-specific immune response similar to what has previously been observed in type 1 diabetes patients and to test for indications of preservation of endogenous insulin production.
The study is an open label Phase IIa feasibility trial. It is a pilot study that does not include a placebo arm.
Antidiabetic medication in the form of metformin is acceptable before and during the trial. Study participants must be insulin independent at baseline, but if the need for insulin treatment develops during the trial, such treatment will be given.
GAD-alum will be injected directly into an inguinal lymph node by a qualified radiologist.
Patients will be followed for a total of 12 months during which their endogenous insulin production and immune response will be evaluated at regular intervals throughout the study period. Urine and blood samples will be taken for safety, diabetes status assessments, vitamin D levels and immunological assessments. Concomitant medication and demographics will be collected.
- Conditions
- Latent Autoimmune Diabetes in Adults
- Being tested
- recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel, Vitamin D
- Keywords
- Glutamic Acid Decarboxylase, Alum Compounds, Injections, Inguinal Canal, Diamyd, rhGAD65, Vitamin D
- Medical subject headings
- Latent Autoimmune Diabetes in Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogelDrug
Also called GAD-alum (Diamyd(R))
3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden
Vitamin DDrug
Also called Divisun 2000 IE
1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden
| Study group | Role | What they receive |
|---|---|---|
| GAD-vaccination with vitamin D suppletion | Experimental | Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart.
Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). Receives: Drug: recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel; Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection Site Skin Reactions
Injection site skin reactions 1 hour post injection, i.e., erythema, oedema, haematoa, tenderness, pain, itching or other finding.
Measured: 1 hour
Occurrence of Adverse Events (AEs) During 5 Months From Baseline.
AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit). The total number of AEs registered for all 14 participants during the first 5 months from baseline was summarized when all 14 participants had completed their 5 months study visit (i.e., 5 months after the baseline visit). At the end of study, when all 14 participants had completed their 12 months study visit, the total number of AEs registered for all 14 participants during the 12 months from baseline was summarized.
Measured: From baseline (first injection of GAD-alum) to 5 months after baseline.
Occurrence of Adverse Events (AEs) During the Study.
AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum). The total number of AEs registered for all 14 participants during the first 5 months from baseline was summarized when all 14 participants had completed their 5 months study visit (i.e., 5 months after the baseline visit). At the end of study, when all 14 participants had completed their 12 months study visit, the total number of AEs registered for all 14 participants during the 12 months from baseline was summarized.
Measured: From baseline (first injection of GAD-alum) to 12 months after baseline.
Serum GAD65A Titers, Change From Baseline at 5 Months After Baseline.
Values present changes in serum GAD65A titers from baseline (first injection of GAD-alum) to 5 months after baseline.
Calculation: Value at 5 months minus value at baseline.
Measured: Baseline (first injection of GAD-alum) and 5 months after baseline.
Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.
Values present changes in serum GAD65A titers from baseline (first injection of GAD-alum) to 12 months after baseline.
Calculation: Value at 12 months minus value at baseline.
Measured: Baseline and 12 months after baseline.
Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.
Values present changes in serum GAD65A titers from baseline (first injection of GAD-alum) to 12 months after baseline.
Calculation: Value at 12 months minus value at baseline.
Measured: Baseline (first injection of GAD-alum) and 12 months after baseline.
Secondary outcomes (6)
Insulin Secretion, Change From Baseline to 5 Months After Baseline.
Values present changes in serum values of glucagon-stimulated C-peptide from baseline (first injection of GAD-alum) to 5 months after baseline.
Calculation: Value at 5 months minus value at baseline.
Measured: Baseline (first injection of GAD-alum) and 5 months after baseline.
Insulin Secretion, Change From Baseline to 12 Months After Baseline.
Values present changes in serum values of glucagon-stimulated C-peptide from baseline (first injection of GAD-alum) to 12 months after baseline.
Calculation: Value at 12 months minus value at baseline.
Measured: Baseline (first injection of GAD-alum) and 12 months after baseline.
Change in HbA1c
HbA1c at 12 months vs. baseline (first injection)
Measured: from baseline to 12 months after the first injection
Change in Fasting Glucose
Change in fasting glucose at 12 months vs baseline (first injection)
Measured: From baseline to 12 months after the first injection
Change in Fasting C-peptide
Change in fasting glucose at 12 months vs baseline (first injection)
Measured: Between baseline and 12 months after the first injection
Change in Maximum C-peptide During Mixed Meal Tolerance Test (MMTT)
Change in maximum C-peptide value at 12 months vs baseline (first injection)
Measured: between baseline 12 months after the first injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start2 Mar 2020
- Primary completion5 May 2022
- Study completion5 May 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent Autoimmune Diabetes in AdultsStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Diamyd Medical AB, Karolinska Institutet, Linkoeping University
- Responsible party
- Sponsor
- Investigators
- Anne Hildur Henriksen, MD PhD, Study director, St Olavs Hospital, Medisinsk KlinikkTorstein Baade Rø, MD, Study director, Norwegian University of Science and Technology, IKOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262479
- Sponsor's protocol ID
- GADinLADA
- Other IDs
- 2019-002692-34, 2019
- Acronym
- GADinLADA
- Status last verified
- Jun 2025
- First submitted
- 5 Feb 2020
- Last updated
- 8 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Hals IK, Fiskvik Fleiner H, Reimers N, Astor MC, Filipsson K, Ma Z, Grill V, Bjorklund A. Investigating optimal beta-cell-preserving treatment in latent autoimmune diabetes in adults: Results from a 21-month randomized trial. Diabetes Obes Metab. 2019 Oct;21(10):2219-2227. doi: 10.1111/dom.13797. Epub 2019 Jun 19.
PubMed 31148332
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Safety, Feasibility and Insulin-promotion by Intra-inguinal Lymph Node Injections of Glutamic Acid Decarboxylase (GAD) in Patients With LADA Type of Diabetes
- ClinicalTrials.gov ID
- NCT04262479
- Acronym / sponsor ID
- GADinLADA / GADinLADA
- Conditions
- Latent Autoimmune Diabetes in Adults
- Keywords
- Glutamic Acid Decarboxylase, Alum Compounds, Injections, Inguinal Canal, Diamyd, rhGAD65, Vitamin D
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Diamyd Medical AB, Karolinska Institutet, Linkoeping University
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Posted 8 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of 3 intra-nodal injections of GAD-alum (Diamyd), together with oral vitamin D supplementation. Safety and feasibility of the treatment will be evaluated and also effects on the immune system and on the preservation of endogenous insulin production.
Detailed description
The purpose of the trial is to evaluate the effects of 3 intra-nodal injections of GAD-alum, together with oral vitamin D supplementation, in a population of LADA patients with high GADA titers. Effects will be summarized at 5 and 12 months after the first injection.
- The primary objective is to evaluate safety and feasibility of this treatment regimen.
- Secondary objectives are to test if the treatment induces a strong GAD-specific immune response similar to what has previously been observed in type 1 diabetes patients and to test for indications of preservation of endogenous insulin production.
The study is an open label Phase IIa feasibility trial. It is a pilot study that does not include a placebo arm.
Antidiabetic medication in the form of metformin is acceptable before and during the trial. Study participants must be insulin independent at baseline, but if the need for insulin treatment develops during the trial, such treatment will be given.
GAD-alum will be injected directly into an inguinal lymph node by a qualified radiologist.
Patients will be followed for a total of 12 months during which their endogenous insulin production and immune response will be evaluated at regular intervals throughout the study period. Urine and blood samples will be taken for safety, diabetes status assessments, vitamin D levels and immunological assessments. Concomitant medication and demographics will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GAD-vaccination with vitamin D suppletion | Experimental | Drug: recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel, Drug: Vitamin DEach study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Signed informed consent by the patient.
- Diagnosis of LADA and diabetes debut within the last 18 months before inclusion. LADA should be defined by the criteria of age ≥30 years at the onset of diabetes, anti-GAD positivity and no clinical need for permanent insulin treatment during the first 3 months after the diagnosis of diabetes.
- Fasting C-peptid levels ≥ 0.3 nmol/l
- High GADA titers (>190 U/ml)
- Patients must be insulin independent at baseline by clinical judgement and C-peptide criteria
Key exclusion criteria (19 listed)
- Current or previous treatment with immunosuppressant therapy (topical or inhaled steroids are accepted)
- Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
- Systemic treatment with glucocorticoids
- Treatment with any vaccine, including influenza vaccine, within 1 month prior to planned first study drug dose or planned treatment with any vaccine up to 1 month after the last injection with study drug
- Antidiabetic medication (metformin excepted)
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 |
|---|---|---|
| recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogelAlso: GAD-alum (Diamyd(R))3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden | Drug | GAD-vaccination with vitamin D suppletion |
| Vitamin DAlso: Divisun 2000 IE1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden | Drug | GAD-vaccination with vitamin D suppletion |
Primary outcome
Injection Site Skin Reactions
Time frame: 1 hour
Injection site skin reactions 1 hour post injection, i.e., erythema, oedema, haematoa, tenderness, pain, itching or other finding.
Occurrence of Adverse Events (AEs) During 5 Months From Baseline.
Time frame: From baseline (first injection of GAD-alum) to 5 months after baseline.
AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit). The total number of AEs registered for all 14 participants during the first 5 months from baseline was summarized when all 14 participants had completed their 5 months study visit (i.e., 5 months after the baseline visit). At the end of study, when all 14 participants had completed their 12 months study visit, the total number of AEs registered for all 14 participants during the 12 months from baseline was summarized.
Occurrence of Adverse Events (AEs) During the Study.
Time frame: From baseline (first injection of GAD-alum) to 12 months after baseline.
AEs were continuously monitored and registered from the baseline visit (first injection of GAD-alum) to the end of study (12 months after the baseline visit/first injection of GAD-alum). The total number of AEs registered for all 14 participants during the first 5 months from baseline was summarized when all 14 participants had completed their 5 months study visit (i.e., 5 months after the baseline visit). At the end of study, when all 14 participants had completed their 12 months study visit, the total number of AEs registered for all 14 participants during the 12 months from baseline was summarized.
Serum GAD65A Titers, Change From Baseline at 5 Months After Baseline.
Time frame: Baseline (first injection of GAD-alum) and 5 months after baseline.
Values present changes in serum GAD65A titers from baseline (first injection of GAD-alum) to 5 months after baseline. Calculation: Value at 5 months minus value at baseline.
Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.
Time frame: Baseline and 12 months after baseline.
Values present changes in serum GAD65A titers from baseline (first injection of GAD-alum) to 12 months after baseline. Calculation: Value at 12 months minus value at baseline.
Serum GAD65A Titers, Change From Baseline at 12 Months After Baseline.
Time frame: Baseline (first injection of GAD-alum) and 12 months after baseline.
Values present changes in serum GAD65A titers from baseline (first injection of GAD-alum) to 12 months after baseline. Calculation: Value at 12 months minus value at baseline.
6 secondary outcomes
Insulin Secretion, Change From Baseline to 5 Months After Baseline.
Time frame: Baseline (first injection of GAD-alum) and 5 months after baseline.
Insulin Secretion, Change From Baseline to 12 Months After Baseline.
Time frame: Baseline (first injection of GAD-alum) and 12 months after baseline.
Change in HbA1c
Time frame: from baseline to 12 months after the first injection
Change in Fasting Glucose
Time frame: From baseline to 12 months after the first injection
Change in Fasting C-peptide
Time frame: Between baseline and 12 months after the first injection
Change in Maximum C-peptide During Mixed Meal Tolerance Test (MMTT)
Time frame: between baseline 12 months after the first injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31148332Hals IK, Fiskvik Fleiner H, Reimers N, Astor MC, Filipsson K, Ma Z, Grill V, Bjorklund A. Investigating optimal beta-cell-preserving treatment in latent autoimmune diabetes in adults: Results from a 21-month randomized trial. Diabetes Obes Metab. 2019 Oct;21(10):2219-2227. doi: 10.1111/dom.13797. Epub 2019 Jun 19.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Anne Hildur Henriksen, MD PhD study director
St Olavs Hospital, Medisinsk Klinikk
Torstein Baade Rø, MD study director
Norwegian University of Science and Technology, IKOM
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel and Vitamin D in people with Latent Autoimmune Diabetes in Adults, run by Norwegian University of Science and Technology at 2 sites in 2 countries.
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 21 inclusion and 19 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 8 Jun 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 Norway, Sweden. 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 8 Jun 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?
Injection Site Skin Reactions (time frame: 1 hour). The study lists 6 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 NCT04262479, 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 8 Jun 2025.