Parkinson DiseasePhase 2NCT07280299
Efficacy, Safety, Tolerability, and Biomarker Effects of GT-02287 in Early Parkinson's Disease
A Phase 2 study testing Low Dose GT-02287 and High Dose GT-02287 in people with Parkinson Disease, run by Gain Therapeutics, Inc..
Trial summary
The purpose of this study is to assess the efficacy, the safety, and the effect on biomarkers of 2 dose levels of oral GT-02287 over placebo after 48 weeks of treatment in treated and untreated participants with early PD. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Low Dose GT-02287 and High Dose GT-02287
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 30 Jun 2028
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent and willing to comply with the requirements and restrictions of the study
- Willing to undergo PD-related genetic testing and analysis
- Any sex, ≥30 and ≤85 years of age
- Body mass index of ≥18 and ≤40 kg/m2 and a body weight of at ≥55 kg and <120 kg at Screening
- Diagnosis of PD based on MDS criteria
- Within 5 years of PD diagnosis
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- Positive SAA in CSF at Baseline
- Hoehn \& Yahr 1-2.5, inclusive
- Naïve to pharmacological treatment for PD with no initiation of dopaminergic treatment expected during the first 9 months of the study or on stable PD medication for ≥3 months prior to Screening, including ≥4 weeks at the same dose(s) immediately before Screening with no changes to dose(s), or medication(s) expected during the first 9 months of the study
- Not pregnant or breastfeeding
- If participant is either of childbearing potential or produces potentially viable sperm, participant must agree to use 2 forms of contraception (barrier method and a second highly effective form of birth control/contraception, as defined in the protocol) if engaging in potentially reproductive intercourse (with a partner who produces potentially viable sperm or is of childbearing potential, respectively)
- Agreeing not to participate in another investigational study while taking part in this study
Who cannot join
- Other neurological disorders, including but not limited to Alzheimer's disease, amyotrophic lateral sclerosis, frontotemporal dementia, progressive supranuclear palsy, corticobasal syndrome, Huntington's disease, multiple system atrophy, dementia with Lewy bodies, secondary (e.g. drug-induced) parkinsonism, multiple sclerosis, or epilepsy
- PD-associated LRRK2 pathogenic variant or other PD-associated genetic mutations other than GBA1
- Severe motor fluctuations and/or disabling dyskinesias based on the investigator's clinical assessment
- Deep-brain stimulation
- Hallucinations, delusions, or other psychotic symptoms requiring antipsychotic medication Use of dopamine antagonists (antipsychotics) or anticholinergic medications
- Dementia by clinical diagnosis and/or a MoCA score of ≤20 and/or a history of behavioral impairment
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- Hypersensitivity to GT 02287 or any of its excipients
- Concomitant medications including drugs metabolized primarily by CYP3A4 that have a narrow therapeutic window, substrates of BCRP that have a narrow therapeutic window, strong or moderate inhibitors or strong inducers of CYP3A4 that could affect the metabolism and plasma levels of GT 02287, including herbal supplements and certain foods.
- Concomitant disease including, but not limited to cardiovascular conditions, diabetes, autoimmune disease, cancer, active infectious disease, psychotic disorders and symptoms, depressive symptoms, drug and/or alcohol misuse as defined in the protocol
- Clinically significant abnormalities in laboratory test
- Contraindications to lumbar puncture (LP) including current treatment with anticoagulants or any other contraindications that might preclude safe completion of the LP
- Blood donation >500 mL within 3 months
- Malabsorption or relevant disorder which may impact the absorption of GT-02287
- Participation in any interventional clinical study within 3 months or 5 half-lives, whichever is longer, prior to Screening
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Phase 2a Study to Evaluate the Clinical Efficacy, Safety, Tolerability, and Biomarker Effects of 2 Dose Levels of GT-02287 in Participants With Early Parkinson's Disease
The purpose of this study is to assess the efficacy, the safety, and the effect on biomarkers of 2 dose levels of oral GT-02287 over placebo after 48 weeks of treatment in treated and untreated participants with early PD.
Read the detailed description
This is a 48-week, double-blind, randomized, placebo-controlled Phase 2a study testing two doses of oral GT-02287 in people with early Parkinson's disease (PD), both treated and untreated.
The study has three parts:
- Screening Period lasting up to 45 days
- Treatment Period lasting about 341 days
- Follow-up Period lasting up to 33 days Participants will have 7 onsite visits for efficacy, safety, tolerability, and biomarker assessments (Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, and a Follow-Up Visit at Week 52). In addition, there will be 5 additional visits for laboratory blood tests (Weeks 2, 16, 20, 30, and 42).
Approximately 111 participants will be randomized into three groups (high dose, low dose, placebo).
Participants can have idiopathic PD or be heterozygous for a pathogenic variant in the GBA1 gene. Participants who have other PD-associated genetic variants (e.g., leucine rich repeat kinase 2 [LRRK2]) are ineligible. All participants will be genotyped to determine their PD-associated genetic status before enrollment.
At the start, participants undergo screening and baseline tests, including motor assessments, quality of life, sensor measurements, and collection of fluid and blood samples for biomarkers. Some baseline tests may be done just before dosing.
The study will measure efficacy through various motor, quality of life, disease progression, non-motor and other symptoms of PD, and cognitive tests, along with wearable sensor data.
Safety will be assessed by recording adverse events, lab tests, vital signs, body weight, heart monitoring, and questionnaires.
The study will also analyze GT-02287 levels in blood and spinal fluid, and its effects on biomarkers.
- Conditions
- Parkinson Disease
- Being tested
- Low Dose GT-02287, High Dose GT-02287, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose GT-02287Drug
Also called GT-02287 400 or 600 mg/day
Sachets containing 400 mg/day or 600 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water.
High Dose GT-02287Drug
Also called GT-02287 800 or 1000 mg/day
Sachets containing 800 mg/day or 1000 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water.
PlaceboDrug
Also called Magnesium aluminometasilicate (MAS)
Sachets containing 420 to 1200 mg of MAS indistinguishable from the active sachets. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose GT-02287 | Active comparator | GT-02287 400 or 600 mg/day Receives: Drug: Low Dose GT-02287 |
| High Dose GT-02287 | Active comparator | GT-02287 800 or 1000 mg/day Receives: Drug: High Dose GT-02287 |
| Placebo | Placebo comparator | Magnesium aluminometasilicate (MAS) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 48 in the sum of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and Part III score [Efficacy]
Change from Baseline to Week 48 in the sum of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and Part III score assessed in the practically defined OFF state. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of four parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be rated by the patient and/or caregiver. Part III assesses the motor signs of PD and is rated by the investigator (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD.
Measured: From baseline to Week 48
Secondary outcomes (8)
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Incidence, nature, relationship to investigational product (IP), and severity of adverse events (AEs); Incidence of clinically significant findings for clinical laboratory evaluations, physical and neurological examinations, body weight , vital signs measurements, 12-lead o 12-lead electrocardiograms (ECGs), Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: From baseline to Week 48
Change from Baseline to Week 48 in the MDS-UPDRS Part II score [Effect on motor function]
Change from Baseline to Week 48 in the MDS-UPDRS Part II score. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of four parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be rated by the patient and/or caregiver. A higher score indicates more severe symptoms of PD.
Measured: From baseline to Week 48
Change from Baseline to Week 48 in the MDS-UPDRS Part III score [Effect on motor function]
Change from Baseline to Week 48 in the MDS-UPDRS Part III score assessed in the practically defined OFF state. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of four parts. Part III assesses the motor signs of PD and is rated by the investigator (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD.
Measured: From baseline to Week 48
Change from Baseline to Week 48 in the Timed Up and Go (TUG) test [Effect on motor function]
Change from Baseline to Week 48 in the Timed Up and Go (TUG) test performed in the practically defined OFF state. The TUG is a clinical test for assessing functional mobility and balance, where a person times how long it takes to stand up from a chair, walk 3 meters, turn 180 degrees, walk back, and sit down again. A time of less than 14 to 15 seconds indicates good mobility, while longer times suggest an increased risk of falling, poor physical performance, and potentially neurological issues.
Measured: From baseline to Week 48
Change from Baseline to Week 48 in the Parkinson's Disease Questionnaire 39 (PDQ-39) score [Effect on quality of life]
Change from Baseline to Week 48 in the Parkinson's Disease Questionnaire 39 (PDQ-39) score. The PDQ-39 is a 39-item self-report questionnaire, which assesses PD-specific health-related quality over the last month. The questionnaire measures 39 items, which assess 8 domains of health: mobility (10 items), activities of daily living (6 items), emotional well being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), and bodily discomfort (3 items). Each item is scored on the following scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = always. Items in each subscale and the total scale can be summarized into an index and transformed linearly to a scale from 0 (perfect health as assessed by the measure) to 100 (worst health as assessed by the measure).
Measured: From baseline to Week 48
Change from Baseline to Week 48 in the Schwab and England Activities of Daily Living (SEADL) scale [Effect on activities of daily living]
Change from Baseline to Week 48 in the Schwab and England Activities of Daily Living (SEADL) scale. The SEADL Scale assesses the capabilities of people with impaired mobility in a range of life activities. The scale uses a percentage score to rate a person's abilities, with 100% indicating complete independence (able to do all chores without slowness, difficulty, or impairment) and 0% indicating full dependence (bedridden and almost completely comatose).
Measured: From baseline to Week 48
Change from Baseline to Week 48 in the Patient Global Impression Scale - Severity (PGI-S)
Change from Baseline to Week 48 in the Patient Global Impression Scale - Severity (PGI-S). The PGI-S is a simple, direct, easy to use scales used to rate the response of a condition to a therapy. It is a transition scale for the participant to rate their condition now as compared with how it was prior to before starting the treatment on a scale from 1 "Very much better" to 7 "Very much worse" with lower scores indicating greater improvement.
Measured: From baseline to Week 48
Change from Baseline to Week 48 in the Clinical Global Impressions Scale - Severity (CGI-S)
Change from Baseline to Week 48 in the Clinical Global Impressions Scale - Severity (CGI-S). The CGI-C scale is a clinician-rated measures of severity of a symptom or condition, using a single item, 6-point-scale. The CGI-S scale ranges from 1 ("None") to 6 ("Very Severe") with lower scores indicating lower severity.
Measured: From baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start30 May 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gain Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonas Hannestad, CMO, Study director, Gain Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280299
- Sponsor's protocol ID
- GANX-001-V103
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Phase 2a Study to Evaluate the Clinical Efficacy, Safety, Tolerability, and Biomarker Effects of 2 Dose Levels of GT-02287 in Participants With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07280299
- Acronym / sponsor ID
- GANX-001-V103
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Gain Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 12 Dec 2025 (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.
The purpose of this study is to assess the efficacy, the safety, and the effect on biomarkers of 2 dose levels of oral GT-02287 over placebo after 48 weeks of treatment in treated and untreated participants with early PD.
Detailed description
This is a 48-week, double-blind, randomized, placebo-controlled Phase 2a study testing two doses of oral GT-02287 in people with early Parkinson's disease (PD), both treated and untreated.
The study has three parts:
- Screening Period lasting up to 45 days
- Treatment Period lasting about 341 days
- Follow-up Period lasting up to 33 days Participants will have 7 onsite visits for efficacy, safety, tolerability, and biomarker assessments (Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, and a Follow-Up Visit at Week 52). In addition, there will be 5 additional visits for laboratory blood tests (Weeks 2, 16, 20, 30, and 42).
Approximately 111 participants will be randomized into three groups (high dose, low dose, placebo).
Participants can have idiopathic PD or be heterozygous for a pathogenic variant in the GBA1 gene. Participants who have other PD-associated genetic variants (e.g., leucine rich repeat kinase 2 [LRRK2]) are ineligible. All participants will be genotyped to determine their PD-associated genetic status before enrollment.
At the start, participants undergo screening and baseline tests, including motor assessments, quality of life, sensor measurements, and collection of fluid and blood samples for biomarkers. Some baseline tests may be done just before dosing.
The study will measure efficacy through various motor, quality of life, disease progression, non-motor and other symptoms of PD, and cognitive tests, along with wearable sensor data.
Safety will be assessed by recording adverse events, lab tests, vital signs, body weight, heart monitoring, and questionnaires.
The study will also analyze GT-02287 levels in blood and spinal fluid, and its effects on biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose GT-02287 | Active comparator | Drug: Low Dose GT-02287GT-02287 400 or 600 mg/day |
| High Dose GT-02287 | Active comparator | Drug: High Dose GT-02287GT-02287 800 or 1000 mg/day |
| Placebo | Placebo comparator | Drug: PlaceboMagnesium aluminometasilicate (MAS) |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able and willing to provide written informed consent and willing to comply with the requirements and restrictions of the study
- Willing to undergo PD-related genetic testing and analysis
- Any sex, ≥30 and ≤85 years of age
- Body mass index of ≥18 and ≤40 kg/m2 and a body weight of at ≥55 kg and <120 kg at Screening
- Diagnosis of PD based on MDS criteria
Key exclusion criteria (14 listed)
- Other neurological disorders, including but not limited to Alzheimer's disease, amyotrophic lateral sclerosis, frontotemporal dementia, progressive supranuclear palsy, corticobasal syndrome, Huntington's disease, multiple system atrophy, dementia with Lewy bodies, secondary (e.g. drug-induced) parkinsonism, multiple sclerosis, or epilepsy
- PD-associated LRRK2 pathogenic variant or other PD-associated genetic mutations other than GBA1
- Severe motor fluctuations and/or disabling dyskinesias based on the investigator's clinical assessment
- Deep-brain stimulation
- Hallucinations, delusions, or other psychotic symptoms requiring antipsychotic medication Use of dopamine antagonists (antipsychotics) or anticholinergic medications
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 |
|---|---|---|
| Low Dose GT-02287Also: GT-02287 400 or 600 mg/daySachets containing 400 mg/day or 600 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water. | Drug | Low Dose GT-02287 |
| High Dose GT-02287Also: GT-02287 800 or 1000 mg/daySachets containing 800 mg/day or 1000 mg/day of active (GT-02287), depending on the participant's body weight. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water. | Drug | High Dose GT-02287 |
| PlaceboAlso: Magnesium aluminometasilicate (MAS)Sachets containing 420 to 1200 mg of MAS indistinguishable from the active sachets. Each daily dose will be prepared as an oral suspension by mixing the content of 1 sachet with the vehicle (supplied in an amber glass bottle) and the requisite volume of tap water. | Drug | Placebo |
Primary outcome
Change from Baseline to Week 48 in the sum of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and Part III score [Efficacy]
Time frame: From baseline to Week 48
Change from Baseline to Week 48 in the sum of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and Part III score assessed in the practically defined OFF state. MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of four parts. Part II assesses motor experiences of daily living (Range 0-52). It contains 13 questions which are to be rated by the patient and/or caregiver. Part III assesses the motor signs of PD and is rated by the investigator (Range 0-132). Part III contains 33 scores based on 18 items. For each question a numeric score is assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. A higher score indicates more severe symptoms of PD.
8 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Time frame: From baseline to Week 48
Change from Baseline to Week 48 in the MDS-UPDRS Part II score [Effect on motor function]
Time frame: From baseline to Week 48
Change from Baseline to Week 48 in the MDS-UPDRS Part III score [Effect on motor function]
Time frame: From baseline to Week 48
Change from Baseline to Week 48 in the Timed Up and Go (TUG) test [Effect on motor function]
Time frame: From baseline to Week 48
Change from Baseline to Week 48 in the Parkinson's Disease Questionnaire 39 (PDQ-39) score [Effect on quality of life]
Time frame: From baseline to Week 48
Change from Baseline to Week 48 in the Schwab and England Activities of Daily Living (SEADL) scale [Effect on activities of daily living]
Time frame: From baseline to Week 48
Change from Baseline to Week 48 in the Patient Global Impression Scale - Severity (PGI-S)
Time frame: From baseline to Week 48
Change from Baseline to Week 48 in the Clinical Global Impressions Scale - Severity (CGI-S)
Time frame: From baseline to Week 48
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 12 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Jonas Hannestad, CMO study director
Gain Therapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low Dose GT-02287 and High Dose GT-02287 in people with Parkinson Disease, run by Gain Therapeutics, Inc..
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 12 inclusion and 14 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: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Gain Therapeutics Clinical Operations (+41919211131, info@gaintherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 48 in the sum of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II score and Part III score [Efficacy] (time frame: From baseline to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.