Latent Autoimmune Diabetes in Adults (LADA)NCT07460336
Effects of Cofrogliptin on Beta-Cell Function in LADA Patients
A study testing Cofrogliptin, Vitamin D3 and Metformin in people with Latent Autoimmune Diabetes in Adults (LADA), run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This single-center, randomized, open-label, controlled study aims to evaluate the effect of cofrogliptin on pancreatic β-cell function in adults with latent autoimmune diabetes in adults (LADA). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Latent Autoimmune Diabetes in Adults (LADA)
- What is being tested?
- Cofrogliptin, Vitamin D3 and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 31 Dec 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Voluntarily signed informed consent.
- 2. Age 18 to 70 years, inclusive.
- 3. Diagnosed with LADA, defined as meeting all of the following:
- (1) Meets 1999 WHO criteria for diabetes mellitus.
- (2) Age at diagnosis of diabetes ≥ 18 years.
- (3) Positive for at least one islet autoantibody (GADA, IA-2A, or ZnT8A).
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- (4) Did not require continuous insulin therapy for at least 6 months after diagnosis.
- 4. Stimulated C-peptide ≥ 200 pmol/L.
- 5. Glycated Hemoglobin (HbA1c) ≤ 9.0%.
- 6. For women of childbearing potential, must agree to use a highly effective method of contraception throughout the study.
Who cannot join
- 1. Pregnant, breastfeeding, or planning to become pregnant during the study.
- 2. Gestational diabetes or other specific types of diabetes.
- 3. Known hypersensitivity to Cogliptin, Vitamin D3, or their excipients.
- 4. Use of DPP-4 inhibitors, GLP-1 receptor agonists, or thiazolidinediones (TZDs) within 8 weeks prior to randomization.
- 5. Hypercalcemia (serum calcium above the upper limit of the normal range).
- 6. Systemic corticosteroid therapy (oral or IV) for more than 7 consecutive days within 6 months prior to screening.
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- 7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN), or total bilirubin > 2 times ULN.
- 8. Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m².
- 9. History of acute diabetic complications such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state.
- 10. History of pancreatitis or pancreatic surgery.
- 11. New York Heart Association (NYHA) class III or IV congestive heart failure, or known left ventricular ejection fraction (LVEF) < 40%.
- 12. History of malignancy.
- 13. Severe psychiatric illness.
- 14. History of alcohol or illicit drug dependence.
- 15. Any other severe systemic disease that the investigator deems unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chuqing Cao, PhD contact
China1 site
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410000
Zhiguang Zhou, MD,PhD, +8673185292154, zhouzhiguang@csu.edu.cn
Chuqing Cao, PhD, csuccq@163.com
About this study
Official title: Key Effects of Cofrogliptin on Beta-cell Function in Adults With Latent Autoimmune Diabetes (LADA): A Single-Center, Randomized, Controlled Trial - KOLA Study
This single-center, randomized, open-label, controlled study aims to evaluate the effect of cofrogliptin on pancreatic β-cell function in adults with latent autoimmune diabetes in adults (LADA). Following a screening period of up to 6 weeks, 84 eligible participants will be randomized in a 1:1 ratio via a sealed-envelope method, stratified by baseline GADA titer (≥0.3 vs <0.3). Participants will be assigned to one of two treatment arms: (1) metformin (with or without insulin) plus vitamin D3, or (2) metformin (with or without insulin) plus vitamin D3 and cofrogliptin. Cofrogliptin will be administered orally at a dose of 10 mg once every 2 weeks, and vitamin D3 at 2000 IU once daily, for a total treatment duration of 52 weeks. Study visits are planned at baseline and at Weeks 12, 26, 38, and 52, during which mixed-meal tolerance tests (MMTT) and other protocol-specified assessments will be conducted.
Read the detailed description
Latent autoimmune diabetes in adults (LADA) is a form of autoimmune diabetes characterized by the progressive destruction of pancreatic beta cells. Preclinical and clinical evidence suggests that dipeptidyl peptidase-4 (DPP-4) inhibitors and vitamin D possess immunomodulatory effects that may help preserve residual beta-cell function. Cofrogliptin is a novel, ultra-long-acting DPP-4 inhibitor.
This study will enroll patients with LADA who will first enter a screening period. Eligible participants will be randomized (1:1) into two parallel arms on Day 1. The experimental group will receive cofrogliptin and vitamin D3 in addition to their background therapy. The active comparator group will receive vitamin D3 plus background therapy. Background therapy includes metformin, with insulin permitted and adjusted per investigator's judgment. Follow-up clinic visits are scheduled at Weeks 12, 26, 38, and 52. Efficacy will be assessed through MMTT-derived C-peptide and glucose measurements, as well as other glycemic indices. Safety will be monitored through the recording of adverse events, laboratory tests, and vital signs throughout the 52-week treatment period.
- Being tested
- Cofrogliptin, Vitamin D3, Metformin, Insulin
- Keywords
- LADA, Adult-Onset Autoimmune Diabetes, DPP-4 inhibitor, Beta-cell Function, Randomized Controlled Trial, C-peptide, Vitamin D3, Cofrogliptin
- Medical subject headings
- Latent Autoimmune Diabetes in Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CofrogliptinDrug
5 mg/tablet, oral; 2 tablets (10 mg) once every 2 weeks. Administered from randomization through Week 52.
Vitamin D3Drug
400 IU/capsule, oral; 5 capsules (2000 IU) once daily. Administered from randomization through Week 52.
MetforminDrug
Background therapy. Oral; typical daily dose 1.5 g, adjustable from 1.0 to 1.7 g/day per investigator judgment.
InsulinDrug
Background therapy, as needed. Subcutaneous; individualized daily dose per investigator judgment.
| Study group | Role | What they receive |
|---|---|---|
| Cofrogliptin + Vitamin D3 + Background Therapy | Experimental | Participants will receive Cofrogliptin (10 mg orally every 2 weeks) and Vitamin D3 (2000 IU orally once daily), in addition to background therapy consisting of metformin (with or without insulin), over a period of 52 weeks. Receives: Drug: Cofrogliptin; Drug: Vitamin D3; Drug: Metformin; Drug: Insulin |
| Vitamin D3 + Background Therapy | Active comparator | Participants will receive Vitamin D3 (2000 IU orally once daily), in addition to background therapy consisting of metformin (with or without insulin), for a total duration of 52 weeks. Receives: Drug: Vitamin D3; Drug: Metformin; Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
Change from baseline in the area under the curve from 0 to 120 minutes (AUC0-120) for serum C-peptide during a mixed-meal tolerance test (MMTT), calculated using the trapezoidal rule from C-peptide measured at 0, 60, and 120 minutes.
Measured: Baseline, Week 52
Secondary outcomes (14)
Change From Baseline in 2-hour MMTT C-peptide AUC at Weeks 12, 26, and 38
The 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC) will be calculated using the trapezoidal rule from C-peptide levels measured at 0, 60, and 120 minutes during the MMTT. Change from baseline is defined as the post-baseline value minus the baseline value. This outcome assesses the overall C-peptide response to a standardized meal stimulus.
Measured: Baseline, Week 12, Week 26, Week 38
Change From Baseline in Fasting C-peptide (FCP)
Fasting C-peptide (FCP) is measured from a blood sample taken after an overnight fast of at least 8 hours. It reflects the basal insulin secretion capacity of pancreatic β-cells.
Measured: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in 60-Minute Post-Meal C-peptide
Serum C-peptide will be measured at 60 minutes during the mixed-meal tolerance test (MMTT). Change from baseline is defined as the post-baseline 60-minute C-peptide value minus the baseline 60-minute C-peptide value. This measurement assesses the early dynamic response of pancreatic β-cells to a meal stimulus.
Measured: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in 120-Minute Post-Meal C-peptide
Serum C-peptide will be measured at 120 minutes during the mixed-meal tolerance test (MMTT). Change from baseline is defined as the post-baseline 120-minute C-peptide value minus the baseline 120-minute C-peptide value. This measurement assesses the late dynamic response of pancreatic β-cells to a meal stimulus.
Measured: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Glycated Hemoglobin (HbA1c)
HbA1c provides an indication of the average blood glucose levels over the preceding 2-3 months. This outcome measures the long-term glycemic control in participants.
Measured: Baseline, Week 26, Week 52
Proportion of Participants Achieving HbA1c < 7.0%
The percentage of participants in each group who achieve a target HbA1c level of less than 7.0% (53 mmol/mol), which is a standard therapeutic goal for glycemic control in adults with diabetes.
Measured: Week 12, Week 26, Week 38, Week 52
Change From Baseline in Mean Daily Insulin Dose
The change from baseline in the mean daily insulindose will be calculated as units per kilogram per day (u/kg/day), based on data recorded in participant diaries. This outcome is designed to evaluate the effect of the intervention on the requirement for exogenous insulin.
Measured: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Homeostatic Model Assessment of β-cell function (HOMA-β)
HOMA-β is calculated using fasting glucose and fasting C-peptide levels. It provides an estimate of basal pancreatic β-cell function. Change from baseline is defined as the post-baseline value minus the baseline value.
Measured: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is calculated using fasting glucose and fasting C-peptide levels. It provides an estimate of insulin resistance. Change from baseline is defined as the post-baseline value minus the baseline value.
Measured: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Glutamic Acid Decarboxylase Autoantibody (GADA) Titers
GADA is a marker of the autoimmune process in LADA. Change from baseline is defined as the Week 52 value minus the baseline value. Changes in its titers may reflect modulation of the autoimmune response.
Measured: Baseline, Week 52
Change From Baseline in Insulinoma-Associated Antigen-2 Autoantibody (IA-2A) Titers
IA-2A is a marker of the autoimmune process in LADA. Changes in its titers may reflect modulation of the autoimmune response. Change from baseline is defined as the Week 52 value minus the baseline value.
Measured: Baseline, Week 52
Change From Baseline in Zinc Transporter 8 Autoantibody (ZnT8A) Titers
ZnT8A is a marker of the autoimmune process in LADA. Changes in its titers may reflect modulation of the autoimmune response. Change from baseline is defined as the Week 52 value minus the baseline value.
Measured: Baseline, Week 52
Change From Baseline in Body Weight
Body weight will be measured in kilograms (kg) at scheduled visits. Change from baseline is defined as the post-baseline value minus the baseline value.
Measured: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated as weight in kilograms divided by the square of height in meters (kg/m²) to assess changes in body composition. Change from baseline is defined as the post-baseline value minus the baseline value.
Measured: Baseline, Week 12, Week 26, Week 38, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Latent Autoimmune Diabetes in Adults (LADA)Studies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, randomized, open-label, controlled, parallel-group study with a 1:1 allocation ratio.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguang Zhou, Second Xiangya Hospital of Central South University
- Investigators
- Zhiguang Zhou, MD,PhD, Principal investigator, The Second Xiangya Hospital, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460336
- Sponsor's protocol ID
- KOLA Study
- Status last verified
- May 2026
- First submitted
- 9 Feb 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Key Effects of Cofrogliptin on Beta-cell Function in Adults With Latent Autoimmune Diabetes (LADA): A Single-Center, Randomized, Controlled Trial - KOLA Study
- ClinicalTrials.gov ID
- NCT07460336
- Acronym / sponsor ID
- KOLA Study
- Keywords
- LADA, Adult-Onset Autoimmune Diabetes, DPP-4 inhibitor, Beta-cell Function, Randomized Controlled Trial, C-peptide, Vitamin D3, Cofrogliptin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Mar 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.
This single-center, randomized, open-label, controlled study aims to evaluate the effect of cofrogliptin on pancreatic β-cell function in adults with latent autoimmune diabetes in adults (LADA). Following a screening period of up to 6 weeks, 84 eligible participants will be randomized in a 1:1 ratio via a sealed-envelope method, stratified by baseline GADA titer (≥0.3 vs <0.3). Participants will be assigned to one of two treatment arms: (1) metformin (with or without insulin) plus vitamin D3, or (2) metformin (with or without insulin) plus vitamin D3 and cofrogliptin. Cofrogliptin will be administered orally at a dose of 10 mg once every 2 weeks, and vitamin D3 at 2000 IU once daily, for a total treatment duration of 52 weeks. Study visits are planned at baseline and at Weeks 12, 26, 38, and 52, during which mixed-meal tolerance tests (MMTT) and other protocol-specified assessments will be conducted.
Detailed description
Latent autoimmune diabetes in adults (LADA) is a form of autoimmune diabetes characterized by the progressive destruction of pancreatic beta cells. Preclinical and clinical evidence suggests that dipeptidyl peptidase-4 (DPP-4) inhibitors and vitamin D possess immunomodulatory effects that may help preserve residual beta-cell function. Cofrogliptin is a novel, ultra-long-acting DPP-4 inhibitor.
This study will enroll patients with LADA who will first enter a screening period. Eligible participants will be randomized (1:1) into two parallel arms on Day 1. The experimental group will receive cofrogliptin and vitamin D3 in addition to their background therapy. The active comparator group will receive vitamin D3 plus background therapy. Background therapy includes metformin, with insulin permitted and adjusted per investigator's judgment. Follow-up clinic visits are scheduled at Weeks 12, 26, 38, and 52. Efficacy will be assessed through MMTT-derived C-peptide and glucose measurements, as well as other glycemic indices. Safety will be monitored through the recording of adverse events, laboratory tests, and vital signs throughout the 52-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, randomized, open-label, controlled, parallel-group study with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Cofrogliptin + Vitamin D3 + Background Therapy | Experimental | Drug: Cofrogliptin, Drug: Vitamin D3, Drug: Metformin, Drug: InsulinParticipants will receive Cofrogliptin (10 mg orally every 2 weeks) and Vitamin D3 (2000 IU orally once daily), in addition to background therapy consisting of metformin (with or without insulin), over a period of 52 weeks. |
| Vitamin D3 + Background Therapy | Active comparator | Drug: Vitamin D3, Drug: Metformin, Drug: InsulinParticipants will receive Vitamin D3 (2000 IU orally once daily), in addition to background therapy consisting of metformin (with or without insulin), for a total duration of 52 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Voluntarily signed informed consent.
- 2. Age 18 to 70 years, inclusive.
- 3. Diagnosed with LADA, defined as meeting all of the following:
- (1) Meets 1999 WHO criteria for diabetes mellitus.
- (2) Age at diagnosis of diabetes ≥ 18 years.
Key exclusion criteria (15 listed)
- 1. Pregnant, breastfeeding, or planning to become pregnant during the study.
- 2. Gestational diabetes or other specific types of diabetes.
- 3. Known hypersensitivity to Cogliptin, Vitamin D3, or their excipients.
- 4. Use of DPP-4 inhibitors, GLP-1 receptor agonists, or thiazolidinediones (TZDs) within 8 weeks prior to randomization.
- 5. Hypercalcemia (serum calcium above the upper limit of the normal range).
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 |
|---|---|---|
| Cofrogliptin5 mg/tablet, oral; 2 tablets (10 mg) once every 2 weeks. Administered from randomization through Week 52. | Drug | Cofrogliptin + Vitamin D3 + Background Therapy |
| Vitamin D3400 IU/capsule, oral; 5 capsules (2000 IU) once daily. Administered from randomization through Week 52. | Drug | Cofrogliptin + Vitamin D3 + Background Therapy, Vitamin D3 + Background Therapy |
| MetforminBackground therapy. Oral; typical daily dose 1.5 g, adjustable from 1.0 to 1.7 g/day per investigator judgment. | Drug | Cofrogliptin + Vitamin D3 + Background Therapy, Vitamin D3 + Background Therapy |
| InsulinBackground therapy, as needed. Subcutaneous; individualized daily dose per investigator judgment. | Drug | Cofrogliptin + Vitamin D3 + Background Therapy, Vitamin D3 + Background Therapy |
Primary outcome
Change From Baseline in 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC)
Time frame: Baseline, Week 52
Change from baseline in the area under the curve from 0 to 120 minutes (AUC0-120) for serum C-peptide during a mixed-meal tolerance test (MMTT), calculated using the trapezoidal rule from C-peptide measured at 0, 60, and 120 minutes.
14 secondary outcomes
Change From Baseline in 2-hour MMTT C-peptide AUC at Weeks 12, 26, and 38
Time frame: Baseline, Week 12, Week 26, Week 38
Change From Baseline in Fasting C-peptide (FCP)
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in 60-Minute Post-Meal C-peptide
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in 120-Minute Post-Meal C-peptide
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Glycated Hemoglobin (HbA1c)
Time frame: Baseline, Week 26, Week 52
Proportion of Participants Achieving HbA1c < 7.0%
Time frame: Week 12, Week 26, Week 38, Week 52
Change From Baseline in Mean Daily Insulin Dose
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Homeostatic Model Assessment of β-cell function (HOMA-β)
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Glutamic Acid Decarboxylase Autoantibody (GADA) Titers
Time frame: Baseline, Week 52
Change From Baseline in Insulinoma-Associated Antigen-2 Autoantibody (IA-2A) Titers
Time frame: Baseline, Week 52
Change From Baseline in Zinc Transporter 8 Autoantibody (ZnT8A) Titers
Time frame: Baseline, Week 52
Change From Baseline in Body Weight
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 12, Week 26, Week 38, Week 52
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 8 May 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.
Chuqing Cao, PhD contact
Zhiguang Zhou, MD,PhD principal investigator
The Second Xiangya Hospital, Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cofrogliptin, Vitamin D3 and Metformin in people with Latent Autoimmune Diabetes in Adults (LADA), run by Second Xiangya Hospital of Central South University at 1 site in China.
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 10 inclusion and 15 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 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 Zhiguang Zhou, MD,PhD (+8673185292154, zhouzhiguang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in 2-hour Mixed-Meal Tolerance Test (MMTT) C-peptide Area Under the Curve (AUC) (time frame: Baseline, Week 52). 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 8 May 2026.