HypoglycemiaPhase 4NCT07818707
Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH)
A Phase 4 study testing Glucagon for Injection (Fresenius Kabi USA), [6,6-2H2] glucose and [13C9, 15N1]-glucagon in people with Hypoglycemia and Hypoglycemia, Reactive, run by Joslin Diabetes Center at 2 sites in United States.
Trial summary
In this study, the investigators will determine (a) whether metabolism (secretion and turnover) of glucagon is altered in patients with PBH, (b) whether this is affected by a meal, (c) whether PBH affects the ability of the body to produce glucose (endogenous glucose production), and (d) whether PBH affects the amount… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia, Hypoglycemia, Reactive, Bariatric Surgery
- What is being tested?
- Glucagon for Injection (Fresenius Kabi USA), [6,6-2H2] glucose and [13C9, 15N1]-glucagon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2026to Jan 2027
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years of age, inclusive, at screening.
- Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
- Males or females at least 2 years following Roux-en-Y gastric bypass (RYGB)
- For patients recruited to PBH group: diagnosed with ongoing PBH, with documented episodes of hypoglycemia, and history of fulfillment of Whipple's triad.
Who cannot join
- Documented hypoglycemia occurring only in the fasting state (>12 hours fast);
- Current diabetes, defined as hemoglobin A1c >6.5% or use of diabetes medications, except for acarbose or miglitol;
- Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
- Hepatic disease, including serum ALT or AST greater than 2 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL; or serum bilirubin > 2.0;
- Congestive heart failure, NYHA class II, III or IV;
- History of myocardial infarction, unstable angina or revascularization within the past 6 months.
Show all 23Show fewer
- Two or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use.
- History of recurrent syncope (unrelated to hypoglycemia) or active diagnosis of a cardiac arrhythmia;
- Current administration of β-blocker therapy;
- History of a cerebrovascular accident;
- Seizure disorder (other than with suspect or documented hypoglycemia);
- Active treatment with long-acting (LAR) octreotide or pasireotide;
- Active malignancy, except basal cell or squamous cell skin cancers;
- Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
- Known insulinoma;
- Major surgical operation within 30 days prior to screening;
- Clinically significant anemia as defined as a hematocrit < 33%;
- Bleeding disorder, treatment with warfarin, or platelet count <50,000;
- Blood donation (1 pint of whole blood) within the past 2 months;
- Active alcohol abuse or substance abuse;
- Current administration of oral or parenteral corticosteroids;
- Pregnancy and/ or lactation: For persons of childbearing potential: there is a requirement for a negative urine pregnancy test before any procedures.
- Not enrolled in another study that uses an investigational drug for this condition.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Alabama
Birmingham, Alabama, 35294
Ananda Basu, MD, 205-975-0471, anandabasu@uabmc.edu
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Mary-Elizabeth Patti, MD, 617-309-2400, mary.elizabeth.patti@joslin.harvard.edu
About this study
In this study, the investigators will determine (a) whether metabolism (secretion and turnover) of glucagon is altered in patients with PBH, (b) whether this is affected by a meal, (c) whether PBH affects the ability of the body to produce glucose (endogenous glucose production), and (d) whether PBH affects the amount of glycogen in the liver (storage form of glucose) when fasting and after a meal. The investigators will determine the effect of glucagon to raise glucose levels after a meal. To answer these questions, participants will receive an infusion of a stable (nonradioactive) isotope of glucose and glucagon, and a meal containing a stable isotope of glucose. Glycogen will be measured by magnetic resonance imaging (MRI) of the liver before and after the meal. This information will be used to develop computer models for the glucagon pump system.
Read the detailed description
The purpose of this study is to assess post-prandial carbohydrate, hormone, and hepatic glycogen metabolism comparing individuals with post-bariatric surgery hypoglycemia (PBH+) to individuals post-bariatric surgery without hypoglycemia (PBH-). There will be 3 visits to the study center in total.
In this study, the investigators will determine (a) whether metabolism (secretion and turnover) of glucagon is altered in patients with PBH, (b) whether this is affected by a meal, (c) whether PBH affects the ability of the body to produce glucose (endogenous glucose production), and (d) whether PBH affects the amount of glycogen in the liver (storage form of glucose) when fasting and after a meal. The investigators will determine the effect of glucagon to raise glucose levels after a meal. To answer these questions, participants will receive an infusion of a stable (nonradioactive) isotope of glucose and glucagon, and a meal containing a stable isotope of glucose. Glycogen will be measured by magnetic resonance imaging (MRI) of the liver before and after the meal. This information will be used to develop computer models for the glucagon pump system.
During Visit 1, the participants will undergo a medical history, physical examination, vital signs, and ECG; inclusion/exclusion criteria will be assessed. Participants will also be advised to complete food log entries and to follow a low glycemic index diet.
At Visit 2, a continuous glucose monitor (CGM sensor) in masked mode will be placed on the participant.
During Visit 3, participants will undergo infusions of glucose, glucagon, and their respective isotope tracers, and will consume a triple tracer mixed meal containing labeled glucose. The participants will complete C13 MRS scans to estimate liver glycogen content. Participants at Joslin Diabetes Center will not have MRS; response to an exogenous subcutaneous glucagon injection in the post-prandial state will be assessed instead. Blood samples will be processed and stored for subsequent analysis.
- Conditions
- Hypoglycemia, Hypoglycemia, Reactive, Bariatric Surgery
- Being tested
- Glucagon for Injection (Fresenius Kabi USA), [6,6-2H2] glucose, [13C9, 15N1]-glucagon, [1-13C] glucose, [2-13C] glucose
- Keywords
- glucagon sensitivity
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon for Injection (Fresenius Kabi USA)Drug
The investigators are assessing glucagon metabolism in individuals with and without PBH in fasting and post-prandial states.
[6,6-2H2] glucoseDrug
The investigators are using a stable isotope glucose tracer to assess glucose metabolism in individuals with and without PBH in fasting and post-prandial states.
[13C9, 15N1]-glucagonDrug
The investigators are assessing the metabolism of glucagon in individuals with and without PBH in fasting and post-prandial states.
[1-13C] glucoseDrug
The investigators are assessing the metabolism of glucose in individuals with and without PBH in fasting and post-prandial states.
[2-13C] glucoseDrug
The investigators assessing the metabolism of glucose in individuals with and without PBH in fasting and post-prandial states.
| Study group | Role | What they receive |
|---|---|---|
| RYGB non-hypoglycemia | Active comparator | Individuals that underwent Roux-en-y gastric bypass (RYGB) at least 2 years prior to recruitment and do not have a diagnosis of PBH. Receives: Drug: Glucagon for Injection (Fresenius Kabi USA); Drug: [6,6-2H2] glucose; Drug: [13C9, 15N1]-glucagon; Drug: [1-13C] glucose; Drug: [2-13C] glucose |
| Post-Bariatric Hypoglycemia (PBH) | Experimental | Individuals that underwent RYGB at least 2 years prior to recruitment and have a diagnosis of PBH. Receives: Drug: Glucagon for Injection (Fresenius Kabi USA); Drug: [6,6-2H2] glucose; Drug: [13C9, 15N1]-glucagon; Drug: [1-13C] glucose; Drug: [2-13C] glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group differences in iAUC for postprandial EGP
Between-group differences in endogenous glucose production (EGP) in the postprandial state, as quantified by iAUC for postprandial EGP. These measurements will be taken at baseline and after mixed-meal consumption, specifically at minutes 10, 20, 30, 60, 90, 120, 150, and 180.
Measured: During Visit 2, within 10 days of the baseline visit
Secondary outcomes (8)
Between-group differences in the integrated postprandial response (iAUC) of Ra glucagon
Between-group differences in glucagon secretion (Ra glucagon) in the postprandial state during mixed meal testing, as quantified by integrated postprandial response (iAUC) of Ra glucagon. These measurements will be taken at baseline and after mixed-meal consumption, specifically at minutes 10, 20, 30, 60, 90, 120, 150, and 180.
Measured: During Visit 2, within 10 days of the baseline visit
Between-group differences in EGP in the fasting state
Between-group differences in EGP in the fasting state, as quantified by fasting EGP. Samples will be collected at baseline before consumption of a mixed meal. This will be measured at baseline.
Measured: During Visit 2, within 10 days of the baseline visit
Between-group differences in iAUC for glucose levels for 60 minutes after postprandial glucagon administration
Between-group differences in glycemic response to exogenous glucagon administration in the postprandial state, following mixed meal testing, as quantified by iAUC glucose for 60 minutes after postprandial glucagon administration. This will be measured at the end of mixed meal testing (180 minutes) and then every 10 minutes for up to 60 minutes.
Measured: During Visit 2, within 10 days of the baseline visit
Between-group differences in insulin sensitivity, as estimated by postprandial SI derived from oral glucose minimal model
Between-group differences in insulin sensitivity, as estimated by postprandial SI derived from oral glucose minimal model. This will be measured after mixed-meal consumption (timepoints 0 minutes).
Measured: During Visit 2, within 10 days of the baseline visit
Between-group differences in insulin secretion, as estimated by postprandial phi total
Between-group differences in insulin secretion, as estimated by postprandial phi total, derived from oral glucose minimal model. This will be measured after mixed-meal consumption (timepoint 0 minutes).
Measured: During Visit 2, within 10 days of the baseline visit
Between-group differences in disposition index derived from oral glucose minimal model
Between group differences in disposition index, as estimated by postprandial DI, derived from oral glucose minimal model. This will be measured after mixed-meal consumption (timepoint 0 minutes).
Measured: During Visit 2, within 10 days of the baseline visit
Between-group differences in basal glycogen content, measured by MRI
Glycogen content will be measured using magnetic resonance imaging (MRI). Spectroscopy will be performed using a 3-Tesla whole-body MR imager/spectrometer. Absolute glycogen concentrations will be calculated from the integrated area of the C1-glycogen signal at 100.1 parts per million referenced to a glycogen phantom, corrected for receiver gain and reception sensitivity. This measurement by MRI will only occur at the University of Alabama at Birmingham.
Measured: During Visit 2, within 10 days of the baseline visit.
Between-group differences in meal-stimulated changes in glycogen content, measured by change from baseline
Glycogen content will be measured using magnetic resonance imaging (MRI). Spectroscopy will be performed using a 3-Tesla whole-body MR imager/spectrometer. Absolute glycogen concentrations will be calculated from the integrated area of the C1-glycogen signal at 100.1 parts per million referenced to a glycogen phantom, corrected for receiver gain and reception sensitivity. This measurement by MRI will only occur at the University of Alabama at Birmingham.
Measured: During Visit 2, within 10 days of the baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start27 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Ananda Basu, MD, Principal investigator, University of Alabama at BirminghamMary-Elizabeth Patti, MD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818707
- Sponsor's protocol ID
- STUDY00000341
- Other IDs
- R01DK137518
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data may be shared with other researchers with permission of local institutional review boards.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Prandial Carbohydrate Metabolism in Individuals With and Without Post-Bariatric Surgery Hypoglycemia (PBH)
- ClinicalTrials.gov ID
- NCT07818707
- Acronym / sponsor ID
- STUDY00000341
- Conditions
- Hypoglycemia, Hypoglycemia, Reactive, Bariatric Surgery
- Keywords
- glucagon sensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Sep 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.
In this study, the investigators will determine (a) whether metabolism (secretion and turnover) of glucagon is altered in patients with PBH, (b) whether this is affected by a meal, (c) whether PBH affects the ability of the body to produce glucose (endogenous glucose production), and (d) whether PBH affects the amount of glycogen in the liver (storage form of glucose) when fasting and after a meal. The investigators will determine the effect of glucagon to raise glucose levels after a meal. To answer these questions, participants will receive an infusion of a stable (nonradioactive) isotope of glucose and glucagon, and a meal containing a stable isotope of glucose. Glycogen will be measured by magnetic resonance imaging (MRI) of the liver before and after the meal. This information will be used to develop computer models for the glucagon pump system.
Detailed description
The purpose of this study is to assess post-prandial carbohydrate, hormone, and hepatic glycogen metabolism comparing individuals with post-bariatric surgery hypoglycemia (PBH+) to individuals post-bariatric surgery without hypoglycemia (PBH-). There will be 3 visits to the study center in total.
In this study, the investigators will determine (a) whether metabolism (secretion and turnover) of glucagon is altered in patients with PBH, (b) whether this is affected by a meal, (c) whether PBH affects the ability of the body to produce glucose (endogenous glucose production), and (d) whether PBH affects the amount of glycogen in the liver (storage form of glucose) when fasting and after a meal. The investigators will determine the effect of glucagon to raise glucose levels after a meal. To answer these questions, participants will receive an infusion of a stable (nonradioactive) isotope of glucose and glucagon, and a meal containing a stable isotope of glucose. Glycogen will be measured by magnetic resonance imaging (MRI) of the liver before and after the meal. This information will be used to develop computer models for the glucagon pump system.
During Visit 1, the participants will undergo a medical history, physical examination, vital signs, and ECG; inclusion/exclusion criteria will be assessed. Participants will also be advised to complete food log entries and to follow a low glycemic index diet.
At Visit 2, a continuous glucose monitor (CGM sensor) in masked mode will be placed on the participant.
During Visit 3, participants will undergo infusions of glucose, glucagon, and their respective isotope tracers, and will consume a triple tracer mixed meal containing labeled glucose. The participants will complete C13 MRS scans to estimate liver glycogen content. Participants at Joslin Diabetes Center will not have MRS; response to an exogenous subcutaneous glucagon injection in the post-prandial state will be assessed instead. Blood samples will be processed and stored for subsequent analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RYGB non-hypoglycemia | Active comparator | Drug: Glucagon for Injection (Fresenius Kabi USA), Drug: [6,6-2H2] glucose, Drug: [13C9, 15N1]-glucagon, Drug: [1-13C] glucose, Drug: [2-13C] glucoseIndividuals that underwent Roux-en-y gastric bypass (RYGB) at least 2 years prior to recruitment and do not have a diagnosis of PBH. |
| Post-Bariatric Hypoglycemia (PBH) | Experimental | Drug: Glucagon for Injection (Fresenius Kabi USA), Drug: [6,6-2H2] glucose, Drug: [13C9, 15N1]-glucagon, Drug: [1-13C] glucose, Drug: [2-13C] glucoseIndividuals that underwent RYGB at least 2 years prior to recruitment and have a diagnosis of PBH. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years of age, inclusive, at screening.
- Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.
- Males or females at least 2 years following Roux-en-Y gastric bypass (RYGB)
- For patients recruited to PBH group: diagnosed with ongoing PBH, with documented episodes of hypoglycemia, and history of fulfillment of Whipple's triad.
Key exclusion criteria (23 listed)
- Documented hypoglycemia occurring only in the fasting state (>12 hours fast);
- Current diabetes, defined as hemoglobin A1c >6.5% or use of diabetes medications, except for acarbose or miglitol;
- Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
- Hepatic disease, including serum ALT or AST greater than 2 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL; or serum bilirubin > 2.0;
- Congestive heart failure, NYHA class II, III or IV;
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 |
|---|---|---|
| Glucagon for Injection (Fresenius Kabi USA)The investigators are assessing glucagon metabolism in individuals with and without PBH in fasting and post-prandial states. | Drug | Post-Bariatric Hypoglycemia (PBH), RYGB non-hypoglycemia |
| [6,6-2H2] glucoseThe investigators are using a stable isotope glucose tracer to assess glucose metabolism in individuals with and without PBH in fasting and post-prandial states. | Drug | Post-Bariatric Hypoglycemia (PBH), RYGB non-hypoglycemia |
| [13C9, 15N1]-glucagonThe investigators are assessing the metabolism of glucagon in individuals with and without PBH in fasting and post-prandial states. | Drug | Post-Bariatric Hypoglycemia (PBH), RYGB non-hypoglycemia |
| [1-13C] glucoseThe investigators are assessing the metabolism of glucose in individuals with and without PBH in fasting and post-prandial states. | Drug | Post-Bariatric Hypoglycemia (PBH), RYGB non-hypoglycemia |
| [2-13C] glucoseThe investigators assessing the metabolism of glucose in individuals with and without PBH in fasting and post-prandial states. | Drug | Post-Bariatric Hypoglycemia (PBH), RYGB non-hypoglycemia |
Primary outcome
Between-group differences in iAUC for postprandial EGP
Time frame: During Visit 2, within 10 days of the baseline visit
Between-group differences in endogenous glucose production (EGP) in the postprandial state, as quantified by iAUC for postprandial EGP. These measurements will be taken at baseline and after mixed-meal consumption, specifically at minutes 10, 20, 30, 60, 90, 120, 150, and 180.
8 secondary outcomes
Between-group differences in the integrated postprandial response (iAUC) of Ra glucagon
Time frame: During Visit 2, within 10 days of the baseline visit
Between-group differences in EGP in the fasting state
Time frame: During Visit 2, within 10 days of the baseline visit
Between-group differences in iAUC for glucose levels for 60 minutes after postprandial glucagon administration
Time frame: During Visit 2, within 10 days of the baseline visit
Between-group differences in insulin sensitivity, as estimated by postprandial SI derived from oral glucose minimal model
Time frame: During Visit 2, within 10 days of the baseline visit
Between-group differences in insulin secretion, as estimated by postprandial phi total
Time frame: During Visit 2, within 10 days of the baseline visit
Between-group differences in disposition index derived from oral glucose minimal model
Time frame: During Visit 2, within 10 days of the baseline visit
Between-group differences in basal glycogen content, measured by MRI
Time frame: During Visit 2, within 10 days of the baseline visit.
Between-group differences in meal-stimulated changes in glycogen content, measured by change from baseline
Time frame: During Visit 2, within 10 days of the baseline visit
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 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant data may be shared with other researchers with permission of local institutional review boards.
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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.
Ananda Basu, MD principal investigator
University of Alabama at Birmingham
Mary-Elizabeth Patti, MD principal investigator
Joslin Diabetes Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucagon for Injection (Fresenius Kabi USA), [6,6-2H2] glucose and [13C9, 15N1]-glucagon in people with Hypoglycemia and Hypoglycemia, Reactive, run by Joslin Diabetes Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group differences in iAUC for postprandial EGP (time frame: During Visit 2, within 10 days of the baseline visit). 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 14 Sep 2026.