Gout DiseaseMETABOGOUTNCT07343336
Landscape of Gout in French Polynesia.
An observational study of Gout Disease and Metabolic Diseases, run by Lille Catholic University at 6 sites in French Polynesia.
Trial summary
The aim of this research is to characterise the genetic and molecular landscape of gout, inflammation and metabolic diseases, as well as the associated molecular, anthropomorphic and pathological characteristics. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout Disease, Metabolic Diseases, Inflammation
- What is being tested?
- Epidemiological study and Blood and urine tests
- How many people
- 2,750 participants
- Where
- 6 sitesFrench Polynesia
- Study dates
- 2 Sep 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population group: Participants will be recruited by general practitioners or study nurses during consultations in community-based practices. The objective is to include a representative general population sample, with no specific reason for consultation required or excluded. Gout group: Patients will be recruited at the Rheumatology Clinic of the Taaone Hospital Center (CHT) in Papeete when presenting with gout symptoms, either tophaceous gout or an acute flare within the previous 48 hours. 2021 follow-up group: Participants from the TOPATA study conducted in 2021 will be recontacted by telephone to assess willingness to participate, followed by an in-person inclusion visit. Only individuals currently living in Tahiti will be contacted. Nurses will be responsible for recruitment, biological sample collection, physical measurements, and questionnaire administration.
Who may be able to join
- All participants:
- Age between 18 and 75 years old inclusive
- Signature of informed consent
- Fasting for the collection of biological samples
- Declared Polynesian ancestry
- Affiliated to a social security scheme
Show all 20Show fewer
- General population group :
- Not having participated to the 2021 TOPATA study
- Visiting a general practitioner (for whatever reason)
- Gout Group :
- Managed at the rheumatology clinic of the Taaone Hospital Centre (CHT) in Papeete by Dr Baptiste Gérard.
- Tophaceous gout sub-group:
- Present with tophaceous gout.
- Gout crisis subgroup:
- Be within 48 hours of the onset of a gout attack
- Agree to return 1 week after inclusion for the second blood and urine sample.
- 2021 follow-up group:
- To have been included in the TOPATA study in 2021
- Have taken the genetic and biological samples that generated the genetic and serum urate data for the 2021 study
- Have hyperuricaemia without signs of gout OR without hyperuricaemia or gout at the time of inclusion in TOPATA
Who cannot join
- All participants :
- Refusal or inability to understand or give consent
- Physical inability to follow and respect the protocol
- 1st degree relative*,
- Person under guardianship or trusteeship
- Pregnant or breast-feeding woman
Show all 12Show fewer
- If several relatives from the same household are eligible to participate, only one person may be included in the study. The choice is left to the discretion of the investigator or the first person met. However, both members of a couple (e.g. husband and wife) may participate.
- General population group :
- Unable to return for sampling if required.
- Gout group :
- Person wearing a knee prosthesis
- People suffering from other inflammatory rheumatic diseases
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
French Polynesia6 sites, 6 recruiting
- Recruiting
Medical Office Dr Antoine Scuiller
Faa'a, 98702
Antoine Scuiller, +689 87 29 99 11, taoteantoine@gmail.com
- Recruiting
Medical Office Dr Cedric Gueguen
Papeete, 98713
Cedric Gueguen, +689 89 51 10 50, Docteur.cedricgueguen@gmail.com
- Recruiting
Medical Office Dr Voradeth Nouanesengsy
Papeete, 98714
Voradeth Nouanesengsy, +689 89 52 59 17, taotevoradeth@gmail.com
- Not yet recruiting
CH de Polynesie Française Papeete
Pirae, 98716
Baptiste Gerard, +689 40 48 62 62, bap.gerard@gmail.com
- Recruiting
Medical Office Dr Nanethida Nouanesengsy
Pirae, 98716
Nanethida Nouanesengsy, +689 87 23 67 12, docteurnane@gmail.com
- Recruiting
Medical Office Dr Raphael Habib
Pirae, 98716
Raphael Habib, +689 40 85 13 23, raphaelhabib@hotmail.fr
About this study
Official title: FENUA-METABOGOUT : Genetic Landscape of Gout, Inflammation and Metabolic Diseases in French Polynesia.
The aim of this research is to characterise the genetic and molecular landscape of gout, inflammation and metabolic diseases, as well as the associated molecular, anthropomorphic and pathological characteristics.
Read the detailed description
Recent work by the GHICL has highlighted the imminent public health problem represented by gout and hyperuricaemia in French Polynesia, with gout affecting around 15% and hyperuricaemia 71.6% of the adult population.
Hyperuricaemia is defined as a serum urate level above the saturation point, leading to its crystallisation under biological conditions. It is generally accepted that hyperuricaemia (HU) begins at 6.0 mg/dL (360 µmol/L).
The best-known consequence of hyperuricaemia is the development of gout, which results from the inflammatory response to the presence of monosodium urate (MSU) crystals in and around the joints. The factors modulating the deposition of MSU crystals in HU are poorly understood and a potential genetic contribution is unknown. It is known that the inflammatory response to the presence of MSU crystal deposits causing gout flares is mediated by activation of the NLRP33 inflammasome, but there is significant variability in this inflammatory response within the same individual (irregular recurrence of flares), and between individuals. The exceptionally high prevalence of HU that have been identified in French Polynesia represents a major health burden, as hyperuricaemia and gout are associated with many other cardiometabolic diseases.
For example, hyperuricaemia, BMI and type 2 diabetes are all associated with the risk of gout. The association between gout and cardiovascular events is also well known, and is thought to be mediated by a persistent inflammatory state. These data are particularly relevant in the context of French Polynesia where, in addition to high rates of gout and HU, a prevalence of obesity of over 40% (BMI >30kg/m2) and a prevalence of diabetes (based on HBA1c measurements) of over 13% was previously identified by the same team.
This last point is particularly striking as the prevalence of diabetes based on self-reported diagnosis was only 7%, indicating that many people are probably undiagnosed and therefore untreated. A better understanding not only of the mechanism and causal link between these conditions and risk factors, but also of the genetic basis of the disease, could lead to the development of therapies and to the improvement in diagnosis. This is particularly crucial in French Polynesia, where hyperuricaemia and its pathological effects on cardiometabolic health affect a large proportion of the adult population.
Here a multi-pronged approach to take advantage of a previous study named 'TOPATA' (NCT04812886) performed previously in French Polynesia, is proposed. The idea is to expand the existing cohort, in order to identify the genetic effectors contributing to the high rates of metabolic diseases previously observed, and to track the longitudinal impacts of HU.
- Conditions
- Gout Disease, Metabolic Diseases, Inflammation
- Being tested
- Epidemiological study, Blood and urine tests
- Keywords
- Gout disease, metabolic disease, inflammation
- Medical subject headings
- Metabolic Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiological studyOther
Collection of sociodemographic data, collection of treatment data, standard and clinical ophthalmological examination, physical and biological measurements, clinical characteristics specific to chronic and metabolic diseases, questionnaires (gout questionnaire, health assessment questionnaire (HAQ-II), EuroQol (EQ)-5D-5L, joint pain, state of health, diet and physical activity, access to care, addictions, sleep quality, pain scale (EVA), personal and family history) will be performed.
Blood and urine testsDiagnostic test
Collection of blood and urine samples for genetic, biochemical, omics, and biobank analyses, in order to characterize cardiometabolic health markers will be performed.
| Study group | Role | What they receive |
|---|---|---|
| General Population Group | Patients aged between 18 and 75 years old who did not take part in the TOPATA study in 2021 and who visit their general practitioner for a consultation (for whatever reason) Receives: Other: Epidemiological study; Diagnostic Test: Blood and urine tests | |
| Gout Group | Patients aged between 18 and 75 years old who are treated at the rheumatology clinic of the Taaone Hospital Centre (CHT) in Papeete by Dr Baptiste Gérard.
* There is a tophaceous gout subgroup: patients with tophaceous gout.
* And a gout attack subgroup: patients presenting with a gout crisis. Receives: Other: Epidemiological study; Diagnostic Test: Blood and urine tests | |
| Follow-up group 2021 | Patients aged between 18 and 75 years old who were included in the TOPATA study in 2021 and for whom genetic and biological samples during the 2021 study were taken.
Patients must have had hyperuricaemia without signs of gout OR without hyperuricaemia or gout at the time of inclusion in the 2021 TOPATA study. Receives: Other: Epidemiological study; Diagnostic Test: Blood and urine tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
GWAS-identified associations between population-enriched genetic variants and health-related traits
Effect estimates (odds ratios or beta coefficients) for statistically significant associations between population-enriched genetic variants and predefined health-related traits identified through GWAS.
Measured: 12 month
Secondary outcomes (9)
Multiple correlation between gout, hyperuricemia, type 2 diabetes and obesity
Anthropometric and biological characteristics of gout, hyperuricemia, type 2 diabetes, and obesity will be assessed, and comorbidity associations analyzed using multivariate logistic regression. Measurements will include waist and hip circumferences, blood pressure, muscle properties by myotonometry, lower-limb strength via chair stand test, and handgrip strength. Blood analyses will assess lipid profile, liver function, inflammation, renal function and metabolism, glucose metabolism, and complete blood count. Urine analyses will also be performed.
Measured: 12 month
Incidence rate of gout or HU in French Polynesia between 2021 and 2025
Incidence rate of gout or HU in French Polynesia between 2021 and 2025 in a sample of participants in the 2021 cohort with asymptomatic HU and no gout.
Measured: 4 years
Proportion of each type of urate-lowering therapy prescribed annually between 2019 and 2025
Breakdown of types of THU prescribed between 2019 and 2025 based on the database of healthcare claims submitted to the Caisse de Prévoyance Sociale (CPS)
Measured: 4 years
Incidence of major adverse cardiovascular events (MACE) in patients with gout, diabetes, or obesity
Occurrence of MACE related to gout, diabetes or obesity on the Healthcare Claims Database (HCD).
Measured: 12 month
Determinants of progression from asymptomatic hyperuricemia (in 2021) to gout (in 2025)
Factors influencing the transition from asymptomatic HU to gout will be sought among demographic, anthropomorphic and biological characteristics, comorbidities, current treatments, genetic profiles, gene expression, proteomic profiles and metabolomic profiles.
Measured: 4 years
Multiple correlation between metabolic changes and disease evolution
Severe gout is defined by subcutaneous tophi. Clinical characteristics will be assessed, including disease features (age at onset, duration), topography (affected joints, mono-/polyarticular and axial involvement), number, duration, and severity of flares, serum uric acid, and presence, number, and size of tophi. Treatment history and response (urate-lowering therapy, flare management), comorbidities (cardiovascular disease, chronic kidney disease, metabolic syndrome, diabetes, obesity, hypertension), and lifestyle factors (diet, alcohol, physical activity) will also be recorded. Molecular and biological characterization will include genetic, transcriptomic, proteomic, and metabolomic analyses to identify biomarkers associated with disease severity and progression.
Measured: 12 month
Multiple correlation between molecular, clinical features and gout severity
Severe gout is defined by subcutaneous tophi. Clinical characteristics will be evaluated, including disease features (age at onset, duration), topography (affected joints, mono-/polyarticular and axial involvement), number, duration, and severity of flares, serum uric acid, and presence, number, and size of tophi. Treatment history and response (urate-lowering therapy, flare management), comorbidities (cardiovascular disease, chronic kidney disease, metabolic syndrome, diabetes, obesity, hypertension), and lifestyle factors (diet, alcohol, physical activity) will also be recorded. Molecular and biological characterization will include genetic, transcriptomic, proteomic, and metabolomic analyses to identify biomarkers linked to disease severity and progression.
Measured: 12 month
Multiple correlation between gout attacks, clinical manifestations, gene expression, proteomic, and metabolomic profiles.
Gout attack characteristics will be investigated, including attack location (affected joints, mono- or polyarticular), pain intensity (VAS or NRS), and inflammatory parameters (CRP, ESR if available, leukocyte count and differential). Synovial fluid analysis will include total and differential cell counts and presence of monosodium urate crystals. Triggering factors (diet, alcohol, trauma, infection, medications), associated acute conditions (infection, surgery, cardiovascular events), and flare duration and severity will be recorded. Treatments and clinical response will also be documented. Molecular characterization will include genetic analyses (urate transport and inflammation variants), gene expression, proteomic profiling of blood and synovial fluid, and metabolomic analyses of serum, urine, and synovial fluid to identify biomarkers of acute flares.
Measured: 12 month
Change in clinical and molecular characteristics of acute gout flares between baseline and 1-week visit
Composite assessment of acute gout flares including clinical characteristics (attack location, mono- or polyarticular involvement, pain intensity measured by VAS or NRS, inflammatory markers [CRP, ESR if available, leukocyte count and differential]), synovial fluid findings (total and differential cell counts and presence of monosodium urate crystals), triggering factors and associated acute conditions, flare duration and severity, treatments administered and clinical response, and molecular biomarkers identified through genetic analyses, gene expression profiling, proteomic analyses, and metabolomic profiling of blood, urine, and synovial fluid.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start2 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Variant Bio, Inc.
- Responsible party
- Sponsor
- Investigators
- Tristan Pascart, Professor, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343336
- Sponsor's protocol ID
- RC-P00126
- Acronym
- METABOGOUT
- Status last verified
- Jan 2026
- First submitted
- 1 Oct 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FENUA-METABOGOUT : Genetic Landscape of Gout, Inflammation and Metabolic Diseases in French Polynesia.
- ClinicalTrials.gov ID
- NCT07343336
- Acronym / sponsor ID
- METABOGOUT / RC-P00126
- Conditions
- Gout Disease, Metabolic Diseases, Inflammation
- Keywords
- Gout disease, metabolic disease, inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,750 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Variant Bio, Inc.
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this research is to characterise the genetic and molecular landscape of gout, inflammation and metabolic diseases, as well as the associated molecular, anthropomorphic and pathological characteristics.
Detailed description
Recent work by the GHICL has highlighted the imminent public health problem represented by gout and hyperuricaemia in French Polynesia, with gout affecting around 15% and hyperuricaemia 71.6% of the adult population.
Hyperuricaemia is defined as a serum urate level above the saturation point, leading to its crystallisation under biological conditions. It is generally accepted that hyperuricaemia (HU) begins at 6.0 mg/dL (360 µmol/L).
The best-known consequence of hyperuricaemia is the development of gout, which results from the inflammatory response to the presence of monosodium urate (MSU) crystals in and around the joints. The factors modulating the deposition of MSU crystals in HU are poorly understood and a potential genetic contribution is unknown. It is known that the inflammatory response to the presence of MSU crystal deposits causing gout flares is mediated by activation of the NLRP33 inflammasome, but there is significant variability in this inflammatory response within the same individual (irregular recurrence of flares), and between individuals. The exceptionally high prevalence of HU that have been identified in French Polynesia represents a major health burden, as hyperuricaemia and gout are associated with many other cardiometabolic diseases.
For example, hyperuricaemia, BMI and type 2 diabetes are all associated with the risk of gout. The association between gout and cardiovascular events is also well known, and is thought to be mediated by a persistent inflammatory state. These data are particularly relevant in the context of French Polynesia where, in addition to high rates of gout and HU, a prevalence of obesity of over 40% (BMI >30kg/m2) and a prevalence of diabetes (based on HBA1c measurements) of over 13% was previously identified by the same team.
This last point is particularly striking as the prevalence of diabetes based on self-reported diagnosis was only 7%, indicating that many people are probably undiagnosed and therefore untreated. A better understanding not only of the mechanism and causal link between these conditions and risk factors, but also of the genetic basis of the disease, could lead to the development of therapies and to the improvement in diagnosis. This is particularly crucial in French Polynesia, where hyperuricaemia and its pathological effects on cardiometabolic health affect a large proportion of the adult population.
Here a multi-pronged approach to take advantage of a previous study named 'TOPATA' (NCT04812886) performed previously in French Polynesia, is proposed. The idea is to expand the existing cohort, in order to identify the genetic effectors contributing to the high rates of metabolic diseases previously observed, and to track the longitudinal impacts of HU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General Population Group | – | Other: Epidemiological study, Diagnostic Test: Blood and urine testsPatients aged between 18 and 75 years old who did not take part in the TOPATA study in 2021 and who visit their general practitioner for a consultation (for whatever reason) |
| Gout Group | – | Other: Epidemiological study, Diagnostic Test: Blood and urine testsPatients aged between 18 and 75 years old who are treated at the rheumatology clinic of the Taaone Hospital Centre (CHT) in Papeete by Dr Baptiste Gérard. * There is a tophaceous gout subgroup: patients with tophaceous gout. * And a gout attack subgroup: patients presenting with a gout crisis. |
| Follow-up group 2021 | – | Other: Epidemiological study, Diagnostic Test: Blood and urine testsPatients aged between 18 and 75 years old who were included in the TOPATA study in 2021 and for whom genetic and biological samples during the 2021 study were taken. Patients must have had hyperuricaemia without signs of gout OR without hyperuricaemia or gout at the time of inclusion in the 2021 TOPATA study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population group: Participants will be recruited by general practitioners or study nurses during consultations in community-based practices. The objective is to include a representative general population sample, with no specific reason for consultation required or excluded. Gout group: Patients will be recruited at the Rheumatology Clinic of the Taaone Hospital Center (CHT) in Papeete when presenting with gout symptoms, either tophaceous gout or an acute flare within the previous 48 hours. 2021 follow-up group: Participants from the TOPATA study conducted in 2021 will be recontacted by telephone to assess willingness to participate, followed by an in-person inclusion visit. Only individuals currently living in Tahiti will be contacted. Nurses will be responsible for recruitment, biological sample collection, physical measurements, and questionnaire administration.
Key inclusion criteria (20 listed)
- Age between 18 and 75 years old inclusive
- Signature of informed consent
- Fasting for the collection of biological samples
- Declared Polynesian ancestry
- Affiliated to a social security scheme
Key exclusion criteria (12 listed)
- Refusal or inability to understand or give consent
- Physical inability to follow and respect the protocol
- 1st degree relative*,
- Person under guardianship or trusteeship
- Pregnant or breast-feeding woman
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 |
|---|---|---|
| Epidemiological studyCollection of sociodemographic data, collection of treatment data, standard and clinical ophthalmological examination, physical and biological measurements, clinical characteristics specific to chronic and metabolic diseases, questionnaires (gout questionnaire, health assessment questionnaire (HAQ-II), EuroQol (EQ)-5D-5L, joint pain, state of health, diet and physical activity, access to care, addictions, sleep quality, pain scale (EVA), personal and family history) will be performed. | Other | Follow-up group 2021, General Population Group, Gout Group |
| Blood and urine testsCollection of blood and urine samples for genetic, biochemical, omics, and biobank analyses, in order to characterize cardiometabolic health markers will be performed. | Diagnostic test | Follow-up group 2021, General Population Group, Gout Group |
Primary outcome
GWAS-identified associations between population-enriched genetic variants and health-related traits
Time frame: 12 month
Effect estimates (odds ratios or beta coefficients) for statistically significant associations between population-enriched genetic variants and predefined health-related traits identified through GWAS.
9 secondary outcomes
Multiple correlation between gout, hyperuricemia, type 2 diabetes and obesity
Time frame: 12 month
Incidence rate of gout or HU in French Polynesia between 2021 and 2025
Time frame: 4 years
Proportion of each type of urate-lowering therapy prescribed annually between 2019 and 2025
Time frame: 4 years
Incidence of major adverse cardiovascular events (MACE) in patients with gout, diabetes, or obesity
Time frame: 12 month
Determinants of progression from asymptomatic hyperuricemia (in 2021) to gout (in 2025)
Time frame: 4 years
Multiple correlation between metabolic changes and disease evolution
Time frame: 12 month
Multiple correlation between molecular, clinical features and gout severity
Time frame: 12 month
Multiple correlation between gout attacks, clinical manifestations, gene expression, proteomic, and metabolomic profiles.
Time frame: 12 month
Change in clinical and molecular characteristics of acute gout flares between baseline and 1-week visit
Time frame: one week
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 15 Jan 2026.
- 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.
Tristan Pascart, Professor principal investigator
GHICL
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gout Disease and Metabolic Diseases, run by Lille Catholic University at 6 sites in French Polynesia.
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 20 inclusion and 12 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in French Polynesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie De Solere (+33 3 20 22 59 31, desolere.marie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GWAS-identified associations between population-enriched genetic variants and health-related traits (time frame: 12 month). 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 15 Jan 2026.