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MASHEarly Phase 1NCT06562361

A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.

A Early Phase 1 study testing [68Ga]Ga-DOTA-Cys-ATH001 in people with MASH and PSC, run by Antaros Medical at 3 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer [68Ga]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers and different patient groups including patients with metabolically caused steatohepatitis… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
MASH, PSC, Fibrostenotic Crohn's Disease
What is being tested?
[68Ga]Ga-DOTA-Cys-ATH001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesSweden
Study dates
Aug 2024to Mar 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Willing and able to give written informed consent for participation in the trial and able to comply with all trial procedures and requirements.
  • Male or female participant aged 18 to 75 years, inclusive, at the screening visit.
  • Body mass index (BMI) ≥ 19 and < 40.0 kg/m2 at the time of the screening visit.
  • Women of childbearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) or must agree to use a highly effective method of contraception with a failure rate of < 1 % to prevent pregnancy from at least 2 weeks prior to administration of tracer for at least 1 week after the PET imaging examination (or for at least 1 weak after the last PET imaging examination for those participants undergoing test/retest PET imaging). In addition, any male partner of a female participant must, unless he has undergone vasectomy, agree to use a condom during the same time period.
  • The following are considered highly effective methods of contraception:
  • combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal),
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  • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable),
  • intra-uterine device [IUD]or intra-uterine hormone-releasing system [IUS]) WOCBP must refrain from donating eggs until 3 months after the last tracer administration.
  • WOCBP with an exclusive male partner who has undergone vasectomy may choose not to use contraceptives.
  • Women of non-childbearing potential are pre-menopausal females who have undergone any of the following surgical procedures; hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, or who are post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with detection of follicle-stimulating hormone [FSH] >25 IU/L is confirmatory).
  • Male participants must be willing to use condom or be vasectomized or practice sexual abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the participant) to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the administration of tracer until 3 months after the administration of tracer. Any female partner of a non-vasectomized male participant who is of childbearing potential must use contraceptive methods with a failure rate of < 1% to prevent pregnancy (see above) from at least 2 weeks prior to administration of tracer to 4 weeks after administration of tracer.
  • Cohort-specific inclusion criteria:
  • Cohort 1 (healthy participants)
  • Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG, and laboratory values at the time of the screening visit, as judged by the Investigator.
  • Cohort 2 (presumed MASH patients) MASH diagnosis based on non-invasive assessments. Participants should have a high level of disease activity with regards to pro-peptide of type III collagen (ProC3) as a marker of ongoing fibrogenesis.
  • Steatosis according to biopsy, radiology, or controlled attenuation parameter (CAP) (≥ 280 dB/M 8), assessments ≤ 24 weeks prior to the screening visit.
  • At least 1 cardiometabolic criteria from the following list:
  • BMI ≥ 25 kg/m2 [23 Asia] OR waist circumference (WC) > 94 cm (M) 80 cm (F) OR ethnicity adjusted, B. Fasting serum glucose ≥ 5.6 mmol/L [100 mg/dL] OR 2-hour post-load glucose levels ≥ 7.8 mmol/L [≥ 140 mg/dL] OR HbA1c ≥ 5.7% [39 mmol/L) OR type 2 diabetes OR treatment for type 2 diabetes, C. Blood pressure ≥ 130/85 mmHg OR specific antihypertensive drug treatment, D. Plasma triglycerides ≥ 1.70 mmol/L [150 mg/dL] OR lipid-lowering treatment, E. Plasma high-density lipoprotein (HDL)-cholesterol ≤ 1.0 mmol/L [40 mg/dL] (M) and ≤ 1.3 mmol/L [50 mg/dL] (F) OR lipid-lowering treatment.
  • ProC3 ≥ 12.6 ng/mL. Cohort 3 (verified MASH patients) MASH diagnosis based on historical liver biopsy. Participants should have a high level of disease activity with regards to ProC3 as a marker of ongoing fibrogenesis, to allow for correlation to PET-tracer uptake.
  • Evidence of steatosis according to biopsy, radiology, or CAP (≥ 280 dB/M) or MRI-PDFF, assessments ≤ 24 weeks prior to the screening visit.
  • At least 1 cardiometabolic criteria from the following list:
  • BMI ≥ 25 kg/m2 [23 Asia] OR WC > 94 cm (M) 80 cm (F) OR ethnicity adjusted, B. Fasting serum glucose ≥ 5.6 mmol/L [100 mg/dL] OR 2-hour post-load glucose levels ≥ 7.8 mmol/L [≥ 140 mg/dL] OR HbA1c ≥ 5.7% [39 mmol/L) OR type 2 diabetes OR treatment for type 2 diabetes, C. Blood pressure ≥ 130/85 mmHg OR specific antihypertensive drug treatment, D. Plasma triglycerides ≥ 1.70 mmol/L [150 mg/dL] lipid-lowering treatment, E. Plasma HDL-cholesterol ≤ 1.0 mmol/L [40 mg/dL] (M) and ≤ 1.3 mmol/L [50 mg/dL] (F) OR lipid-lowering treatment.
  • Historical liver biopsy 24 weeks to 4 weeks prior to inclusion with histologically proven metabolic dysfunction-associated steatotic liver disease (MASLD).
  • ProC3 ≥ 12.6 ng/mL. Cohort 4 (fibrostenotic CD patients)
  • Fibrostenotic CD as evidenced by persistent luminal narrowing with or without obstructive symptoms as assessed with MRI, ≤ 24 weeks prior to the screening visit OR fibrostenotic CD by positive colonoscopy up to 24 weeks prior to the screening visit.
  • Crohn's disease activity index (CDAI) < 150
  • Calprotectin < 250
  • C-reactive protein (CRP) < 20 Cohort 5 (PSC patients)
  • Large duct PSC, including intrahepatic bile duct involvement, according to MRI/MRCP.
  • ProC3 ≥ 12.6 ng/mL

Who cannot join

  • Any contraindication for MRI according to a standard checklist used in clinical practice, including claustrophobia, metallic implants or internal electrical devices (e.g., cochlear implant, nerve stimulator, gastric pacemaker, bladder stimulator, cardiac pacemaker, defibrillator, artificial valves in heart, aneurysm clips or coils, etc.), inability to stay in supine position for 90 minutes, and permanent makeup or tattoos which in the Investigator's opinion might jeopardize the participant's safety or interfere with the imaging assessments.
  • Having worked as a metal worker or welder.
  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial or influence the results or the participant's ability to participate in the trial.
  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the screening visit.
  • Any malignancy within the past 12 months before the screening visit, with the exception of successfully treated basal cell carcinoma of the skin or in situ prostate cancer under active surveillance, with no interventions scheduled during the period of trial participation.
  • Any planned major surgery within the duration of the trial participation.
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  • Participants who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the trial.
  • Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis B or C antibodies and/or human immunodeficiency virus (HIV).
  • Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc.).
  • Poor peripheral venous access, as judged by the Investigator.
  • After 10 minutes of supine rest at the screening visit, any vital signs values outside the following ranges:
  • Systolic blood pressure: < 90 or >165 mmHg, or
  • Diastolic blood pressure < 50 or >100 mmHg, or
  • Pulse < 40 or > 90 bpm
  • The participant has a change in body weight ≥5%, 3 months before the screening visit.
  • The participant has any laboratory abnormality or condition that, in the Investigator's opinion, could adversely affect the safety of the participant or impair the assessment of trial results.
  • Clinically significantly abnormal 12-lead ECG recording result or cardiac symptoms as judged by the Investigator.
  • The participant is using any prohibited concomitant medications as described in the protocol, at the discretion of the Investigator.
  • Current use of any hormone therapy at doses that may cause metabolic interference as judged by the Investigator. Stable hormonal replacement therapy is allowed.
  • Currently participating, or previous participation in another clinical trial within 30 days prior to the screening visit or previous participation in another PET imaging trial within the last 12 months.
  • Positive screening result for alcohol at the screening visit (cohorts 1a and 1b only).
  • Ongoing or previous alcohol abuse, or long-standing excessive intake of alcohol, as judged by the Investigator.
  • Presence or history of drug abuse, as judged by the Investigator.
  • History of, or current use of anabolic steroids, as judged by the Investigator.
  • Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the last 3 months prior to screening.
  • The Investigator considers the participant unlikely to comply with trial procedures, restrictions, and requirements.
  • Additional exclusion criteria for all participants (cohorts 2-5):
  • The participant is receiving treatment with vitamin E, thiazolidinediones, or glucagon-like peptide-1 receptor agonists unless on a stable dose for 3 months before the screening Visit and is anticipated to maintain the same dosing regimen throughout trial participation.
  • Participants with HbA1c ≥48 mmol/mol (6.5%) at screening without a previous diagnosis of T2D must not take part in the study. Participants with a previous diagnosis of T2D are permitted to enter the study if on a stable regimen of antidiabetic therapy for at least 3 months before screening. Participants who are on a stable regimen of antidiabetic therapy for at least 3 months before screening and have HbA1c of ≥ 63 mmol/mol (9%) at screening should be excluded.
  • Clinically significant disease, apart from T2D, which in the opinion of the Investigator might interfere with the interpretation of the trial results and/or the safety of the participant, or in any other way unsuitable for participation in this clinical trial.
  • The participant has a severe immune-mediated inflammatory disease (IMID) (e.g., rheumatoid arthritis, spondylarthritis disease spectrum, connective tissue disorders, cutaneous inflammatory conditions such as psoriasis, atopic dermatitis, hidradenitis suppurativa, asthma, multiple sclerosis). Participants with inactive IMID or active IMID of mild to moderate severity are permitted to enter the trial.
  • Additional exclusion criteria for MASH and PSC participants (cohorts 2-3, and 5)
  • Liver stiffness > 25 kPa by transient elastography or any sign of decompensation. For cohorts 2 and 3, based on the FibroScan® evaluation on the screening visit, and for cohort 5 based on routine elastography performed ≤ 12 months.
  • For participants with biopsy-confirmed fibrosis stage F2 or F3, the participant has any of the following during the screening period:
  • Aspartate aminotransferase (AST) levels > 5 x the upper limit of normal (ULN).
  • Alanine aminotransferase (ALT) levels > 5 x ULN.
  • Alkaline phosphatase (ALP) ≥ 2 x ULN (cohorts 2 and 3) and ALP ≥ 10 (cohort 5).
  • Serum creatinine ≥1.5 x ULN or has an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2 (the revised Lund-Malmö GFR estimating equation will be used).
  • International normalized ratio (INR) \&gt;1.3.
  • Total TBL ≥ULN (except for patients with a documented history of Gilbert's syndrome if direct bilirubin is within the normal reference range).
  • Direct bilirubin ≥ 3 x ULN.
  • Platelet count < 60 x 109/L.
  • Presence or history of ascites, hepatic encephalopathy, or variceal bleeding.
  • Presence or history of Child-Pugh > 6 (Class B or C), unless due to therapeutic anticoagulation.
  • Presence or history of Model for End-Stage Liver disease (MELD) score >12 (only for cohorts 2-3).
  • Note: It is the Investigator's decision, in consultation with the Sponsor, to allow participants to enter the study who have clinically meaningful rising tendencies in liver chemistries or significantly elevated liver chemistries that do not yet satisfy but could be interpreted as clinically concerning (i.e., AST or ALT > 4 x ULN) at any visit during the screening period.
  • The participant has a change in body weight ≥ 5% after qualifying liver biopsy. Additional criteria for fibrostenotic CD participants (cohort 4)
  • MRI findings consistent with only inflammation, i.e., edema, hyperemic intestinal wall, restricted diffusion, mesenteric lymphadenopathy etc.

Trial locations and contacts

3 sites in 1 country.

Johan Vessby, MD, PhD contact

+46 (0)73 356 93 04

johan.vessby@akademiska.se

Sweden3 sites, 3 recruiting

  • CTC Karolinska

    Stockholm, SE-171 64 S

    Kaveh Azizi, MD, +46 (0)76 140 56 21, kaveh.azizi@ctc-ab.se

    Kaveh Azizi, MD

    Recruiting

  • CTC Akademiska Uppsala University Hospital, Entrance 85, 2nd level

    Uppsala, SE-751 85

    Erik Rein-Hedin, MD, +46 (0)70 755 20 89, erik.rein-hedin@ctc-ab.se

    Erik Rein-Hedin, MD

    Not yet recruiting

  • Section of Gastroenterology/Hepatology, Uppsala University Hospital

    Uppsala, SE-751 85

    Johan Vessby, MD, PhD, +46 (0)73 356 93 04, johan.vessby@akademiska.se

    Fredrik Rorsman, MD, PhD

    Not yet recruiting

Other trials in Sweden

About this study

Official title: A First-In-Human, Microdosing, Clinical Trial to Investigate Binding of the PET Tracer [68Ga]Ga-DOTA-CYS-ATH001 Targeting PDGFRβ in Healthy Subjects as Compared to Patients With MASH, PSC and CD

The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer [68Ga]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers and different patient groups including patients with metabolically caused steatohepatitis (MASH), patients with fibrostenotic Crohn´s Disease (CD) and patients with primary sclerosing cholangitis (PSC).The study will also assess the safety of a microdose of 68Ga]Ga-DOTA-Cys-ATH001 and how it is distributed in different parts of the body. The main questions the study aims to answer are:

  • What does the uptake of the [68Ga]Ga-DOTA-Cys-ATH001 PET-tracer look like in the liver of healthy subjects, and in that of patients with MASH and PSC?
  • What does the uptake of the [68Ga]Ga-DOTA-Cys-ATH001 PET-tracer look like in the GI tract of healthy subjects, and that of patients with fibrostenotic CD?
  • How much [68Ga]Ga-DOTA-Cys-ATH001 PET-tracer can be found in the blood after injection?
  • How is [68Ga]Ga-DOTA-Cys-ATH001 uptake distributed in the body?
  • What medical problems do participants have when receiving [68Ga]Ga-DOTA-Cys-ATH001?
Read more

Participants will:

Receive one administration of [68Ga]Ga-DOTA-Cys-ATH001, after which examination with PET is performed. Magnetic Resonance Imaging (MRI) is also used in the study to create a detailed picture of the body and its function which will facilitate the interpretation of the results of the PET examination. A subset of participants will have blood samples collected after the tracer administration to assess the blood levels of the tracer over time.

A subset of participants will come back for a second visit where they will receive a second administration of [68Ga]Ga-DOTA-Cys-ATH001, followed by PET and MRI.

A health check-up is performed before dosing, and a safety assessment will be performed after dosing. A remote follow-up visit is performed the day after the dosing visit.

Read the detailed description

This is a first-in-human (FIH), phase 0, multi-center, non-randomized trial to investigate [68Ga]Ga-DOTA-Cys-ATH001 PET-tracer binding in the liver and in the GI tract in healthy subjects and patients with metabolically caused steatohepatitis (MASH), patients with fibrostenotic Crohn´s Disease (CD) and patients with primary sclerosing cholangitis (PSC), in a total of 5 different cohorts, including a sub-trial to assess test-retest reliability and a sub-trial to assess dosimetry. The allocation of cohorts is:

  • Cohort 1a (n=3): Healthy volunteers, sub-group dosimetry,
  • Cohort 1b (n=3): Healthy volunteers, sub-group test/retest,
  • Cohort 2a (n=3): Presumed MASH patients, sub-group dosimetry,
  • Cohort 2b (n=3): Presumed MASH patients, sub-group test/retest,
  • Cohort 3 (n=6): Verified MASH patients,
  • Cohort 4 (n=6): Fibrostenotic CD patients,
  • Cohort 5 (n=6): PSC patients.

The participants will come for 2 or 3 visits to the trial site. The screening (Visit 1) will include an eligibility check and review of health status. Participants in cohort 2 and cohort 3 will perform a FibroScan® investigation.

At Visit 2, participants will come to the trial site for PET/MRI and safety assessments. The participants will receive a single, bolus iv injection of a maximum of 100 µg [68Ga]Ga-DOTA-Cys-ATH001 after which participants will be examined by whole-body PET/MRI scans. A sub-group of participants in cohort 1 (cohort 1a, healthy subjects, n=3, the first 3 participants in this cohort) and cohort 2 (cohort 2a, presumed MASH patients, n=3, the first 3 participants in this cohort) will be participating in a sub-trial to calculate the whole-body dosimetry of the tracer. These participants will have one longer PET visit and will be examined by sequential whole-body PET/MRI scans to determine tracer biodistribution and clearance. At Visit 4 (within 6 weeks of Visit 2), participants taking part in the test/retest sub-trial (Cohorts 1b and 2b) will come for a second PET/MRI visit which includes a second administration of [68Ga]Ga-DOTA-Cys-ATH001.

To determine tracer clearance from blood, venous (1a and b and 2a and b) and arterial (1b and 2b) PK samples will be collected post-dose. No PK samples will be taken from cohorts 3 to 5.

Safety assessments will take place after the PET/MRI (vital signs, 12-lead ECG, safety laboratory sampling and injection site reactions). A remote follow-up by telephone (Visit 3) will be performed the day after [68Ga]Ga-DOTA-Cys-ATH001 dosing to follow-up on AEs, injection site reactions and concomitant medication.For participants in cohorts 1b and 2b (the test/retest sub-group), a remote follow-up by telephone (Visit 5) will be performed the day after [68Ga]Ga-DOTA-Cys-ATH001 dosing to follow-up on AEs, injection site reactions and concomitant medication.

Being tested
[68Ga]Ga-DOTA-Cys-ATH001
Keywords
PET, Tracer, PDGFRB, MASH, PSC, MRI, Crohn´s Disease
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]Ga-DOTA-Cys-ATH001Drug

    Target dose of 200MBq [68Ga]Ga-DOTA-Cys-ATH001 corresponding to a maximum mass dose of 100 µg, administered as an intravenous bolus dose.

Study groups in NCT06562361
Study groupRoleWhat they receive
100 µg [68Ga]Ga-DOTA-Cys-ATH001 (target dose of 200 MBq)ExperimentalAll participants will receive a single, bolus iv injection of up to 100 µg [68Ga]Ga-DOTA-Cys-ATH001 (target dose of 200 MBq). At Visit 4, cohort 1b (healthy participants, n=3) and cohort 2b (presumed MASH participants, n=3) will come for a second PET/MR imaging visit within 6 weeks from the first imaging visit where an additional bolus iv injection of up to 100 µg [68Ga]Ga-DOTA-Cys-ATH001 will be administered.
Receives: Drug: [68Ga]Ga-DOTA-Cys-ATH001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [68Ga]Ga-DOTA-Cys-ATH001 uptake in the whole liver of healthy subjects compared with patients with MASH and PSC

    Difference in [68Ga]Ga-DOTA-Cys-ATH001 mean standardized uptake value (SUV) in the whole liver of healthy subjects (cohort 1), compared with patients with MASH (cohort 2 and 3) and PSC patients (cohort 5).

    Measured: Assessed during the intervention

  2. [68Ga]Ga-DOTA-Cys-ATH001 uptake in the GI tract of healthy subjects compared with patients with fibrostenotic CD

    Difference in [68Ga]Ga-DOTA-Cys-ATH001 SUV in the GI tract of healthy subjects (cohort 1) compared with patients with fibrostenotic CD (cohort 4).

    Measured: Assessed during the intervention

Secondary outcomes (1)

  1. [68Ga]Ga-DOTA-Cys-ATH001 PET-tracer PK in arterial and venous plasma

    [68Ga]Ga-DOTA-Cys-ATH001 PET-tracer PK (radioactivity associated with the parent compound) in arterial and venous plasma for up to 125 minutes after injection.

    Measured: Assessed 5 minutes to 125 minutes post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study startAug 2024 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06562361
Sponsor's protocol ID
INT008
Other IDs
2023-506555-15-00, 2023
Status last verified
Aug 2024
First submitted
14 Aug 2024
Last updated
29 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [68Ga]Ga-DOTA-Cys-ATH001 in people with MASH and PSC, run by Antaros Medical at 3 sites in Sweden.

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 30 inclusion and 48 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: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Johan Vessby, MD, PhD (+46 (0)73 356 93 04, johan.vessby@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[68Ga]Ga-DOTA-Cys-ATH001 uptake in the whole liver of healthy subjects compared with patients with MASH and PSC (time frame: Assessed during the intervention). 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 NCT06562361.

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 29 Aug 2024.

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