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Type 1 DiabetesNCT06422325

Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

A study testing MPC closed-loop system in insulin only mode and MPC closed-loop system in insulin/pramlintide mode in people with Type 1 Diabetes, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
MPC closed-loop system in insulin only mode and MPC closed-loop system in insulin/pramlintide mode
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
12 Jul 2024to 28 Jan 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Diagnosis of type 1 diabetes mellitus for at least 1 year.
  • Participants 18 to 70 years of age.
  • Current use of an insulin pump for at least 3 months with stable insulin pump settings for >2 weeks OR current use of multiple day injection insulin therapy with stable doses for >2 weeks.
  • Uses a carbohydrate ratio, at lease occasionally, to dose meal time insulin.
  • HbA1c ≤ 10.5% at screening.
  • Total daily insulin requirement is less than 139 units/day.
  • Willingness to follow all study procedures, including attending all clinic visits.
  • Willingness to sign informed consent and HIPAA documents.

Who cannot join

  • Individual of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence.
  • Any cardiovascular disease, defined as a clinically significant EKG abnormality at the time of screening or any history of: stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or 3rd degree heart block or any non-physiological arrhythmia judged by the investigator to be exclusionary.
  • Renal insufficiency (GFR < 60 ml/min, using the MDRD equation as reported by the OHSU laboratory).
  • Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
  • History of severe hypoglycemia during the past 3 months prior to screening visit or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
  • History of diabetes ketoacidosis during the prior 3 months prior to screening visit, as diagnosed on hospital admission or as judged by the investigator.
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  • Adrenal insufficiency.
  • Any active infection requiring treatment (example soft tissue infection requiring antibiotics).
  • Known or suspected abuse of alcohol, narcotics, or illicit drugs.
  • Seizure disorder.
  • Active foot ulceration.
  • Major surgical operation within 30 days prior to screening.
  • Use of an investigational drug within 30 days prior to screening.
  • Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
  • Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
  • Allergy to aspart insulin.
  • Allergy to pramlintide.
  • Current administration of oral or parenteral corticosteroids.
  • Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the past 5 years prior to screening (except basal and squamous cell skin cancer).
  • Current use of any medication intended to lower glucose other than insulin or pramlintide (ex. use of liraglutide, metformin).
  • Gastroparesis
  • Diets consisting of less than 50 grams of carbohydrates per day.
  • Dietary restrictions or allergies to the study meals
  • Any clinically significant disease or disorder which in the opinion of the Investigator may jeopardize the participant's safety or compliance with the protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health and Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: A Crossover Study to Evaluate Insulin/Pramlintide Versus Insulin Alone Delivery Strategy

The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide. Pramlintide is a drug that is used with mealtime insulin to control blood sugar in people who have diabetes. It works by slowing down the movement of food through the stomach which prevents blood sugar from rising too high after a meal. The closed loop system will receive glucose values from the Dexcom G6 continuous glucose monitoring (CGM) and automatically send commands to one Omnipod for insulin and one Omnipod for pramlintide delivery.

Read the detailed description

Participants will undergo two 12.5 hour clinic visits. Participants will complete a training on how to start the Dexcom G6 sensor at home. Participants will start the G6 sensor the day before each study visit. For one visit, the system will use insulin only for managing blood sugar. For the other study, the system will use both insulin and pramlintide. The order of the visits will be randomly chosen. For 3 days before the insulin and pramlintide visit, participants will dose with pramlintide before each meal. During the visits, participants will wear one or two Omnipods to delivery insulin and insulin/pramlintide and a Dexcom G6 CGM. The CGM system will provide sensor glucose data every 5 minutes. Sensor glucose data will be wirelessly transmitted via Bluetooth Low Energy (BTLE) from the Dexcom G6 to the smartphone master controller every 5 minutes. The smartphone will communicate via BTLE to an Omnipod for insulin delivery. The closed loop system will receive activity data through a Polar M600 watch worn by the participant. Participants will eat breakfast and lunch in clinic.

Conditions
Type 1 Diabetes
Being tested
MPC closed-loop system in insulin only mode, MPC closed-loop system in insulin/pramlintide mode
Keywords
automated insulin delivery systems, glucose sensor, pramlintide
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • MPC closed-loop system in insulin only modeDevice

    The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer insulin continuously for managing blood sugar.

  • MPC closed-loop system in insulin/pramlintide modeDevice

    The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal in puts. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure (METs). The METs then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM. The MPC also has missed meal insulin bolus detection where the system will calculate the amount of insulin that was missed for a meal. The missed meal boluses can be delivered automatically without any input from the user. This feature can also be disabled. The device in this mode will administer both insulin and pramlintide continuously for managing blood sugar. The system will deliver pramlintide in a fixed ratio to insulin at 6 mcg of pramlintide delivered for every 1 unit of insulin.

Study groups in NCT06422325
Study groupRoleWhat they receive
Insulin Only ArmExperimentalParticipants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
Receives: Device: MPC closed-loop system in insulin only mode
Insulin and Pramlintide ArmExperimentalParticipants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.
Receives: Device: MPC closed-loop system in insulin/pramlintide mode

What is being measured

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

  1. Incremental Area Under the Curve of Postprandial Glucose Following the First Meal

    Incremental area under the curve (iAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are (mg/dL*min)/1000.

    Measured: 6 hours following first meal

  2. Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

    Measured: 6 hours following first meal

Secondary outcomes (46)

  1. Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal

    Incremental area under the curve (iAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose for the obseration period. Values shown are iAUC/1000.

    Measured: 6 hours following second meal

  2. Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following Second Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

    Measured: 6 hours following second meal

  3. Net Area Under the Curve of Postprandial Glucose Following the First Meal

    Net area under the curve (netAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL*min)/1000.

    Measured: 6 hours following first meal

  4. Net Area Under the Curve of Postprandial Glucose Following the Second Meal

    Net area under the curve (netAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dl *min)/1000

    Measured: 6 hours following second meal

  5. Net Area Under the Curve of Postprandial Glucose

    Net area under the curve (netAUC) of postprandial glucose (mg/dL*min) calculated using a trapezoidal method, which sums all continuous glucose monitoring (CGM) values above the starting glucose and subtracts CGM values below the starting glucose for the observation period. Values shown are (mg/dL*min)/1000.

    Measured: 12 hour clinic visit

  6. Percent of Time With Sensed Glucose <70 mg/dL Following First Meal

    Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor in the 6 hours following the start of the first meal. Because so few participants had any sensed glucose values <70 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <70 mg/dL

    Measured: 6 hours following first meal

  7. Percent of Time With Sensed Glucose <70 mg/dL Following Second Meal

    Because so few participants had any sensed glucose values <70 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <70 mg/dL

    Measured: 6 hours following second meal

  8. Percent of Time With Sensed Glucose <70 mg/dL

    Because so few participants had any sensed glucose values <70 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <70 mg/dL

    Measured: 12 hour clinic visit

  9. Percent of Time With Sensed Glucose Between 70-140 mg/dL Following First Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

    Measured: 6 hours following first meal

  10. Percent of Time With Sensed Glucose Between 70-140 mg/dL Following Second Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

    Measured: 6 hours following second meal

  11. Percent of Time With Sensed Glucose Between 70-140 mg/dL

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve hours of the clinic visit as the denominator.

    Measured: 12 hour clinic visit

  12. Mean Sensed Glucose Following First Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal.

    Measured: 6 hours following first meal

  13. Mean Sensed Glucose Following Second Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the six hours following the meal.

    Measured: 6 hours following second meal

  14. Mean Sensed Glucose

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The outcome is calculated as the average of these values for the twelve-hour clinic visit.

    Measured: 12 hour clinic visit

  15. Percent of Time With Sensed Glucose <54 mg/dL Following First Meal

    Because so few participants had any sensed glucose values <54 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <54 mg/dL

    Measured: 6 hours following first meal

  16. Percent of Time With Sensed Glucose <54 mg/dL Following Second Meal

    Because so few participants had any sensed glucose values <54 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <54 mg/dL

    Measured: 6 hours following second meal

  17. Percent of Time With Sensed Glucose <54 mg/dL

    Because so few participants had any sensed glucose values <54 mg/dL, this summary shows the count of participants with any time (>0) with sensed glucose <54 mg/dL.

    Measured: 12 hour clinic visit

  18. Percent of Time With Sensed Glucose >180 mg/dL Following First Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

    Measured: 6 hours following first meal

  19. Percent of Time With Sensed Glucose >180 mg/dL Following Second Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours following the meal as the denominator.

    Measured: 6 hours following second meal

  20. Percent of Time With Sensed Glucose >180 mg/dL

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve-hour clinic visit as the denominator.

    Measured: 12 hour clinic visit

  21. Percent of Time With Sensed Glucose >250 mg/dL Following First Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours after the meal as the denominator.

    Measured: 6 hours following first meal

  22. Percent of Time With Sensed Glucose >250 mg/dL Following Second Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the six hours after the meal as the denominator.

    Measured: 6 hours following second meal

  23. Percent of Time With Sensed Glucose >250 mg/dL

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. Percent of time in range can take values between 0 and 100 and uses the twelve hours of the clinic visit as the denominator.

    Measured: 12 hour clinic visit

  24. Median Amount of Insulin Delivered Following First Meal

    Amount of insulin (units) delivered in the 6 hours following the first meal.

    Measured: 6 hours following the first meal

  25. Median Amount of Insulin Delivered Following Second Meal

    Amount of insulin (units) delivered. in the 6 hours following the second meal.

    Measured: 6 hours following the second meal

  26. Median Amount of Insulin Delivered

    Amount of insulin (units) delivered

    Measured: 12 hour clinic visit

  27. Median Amount of Pramlintide Delivered Following First Meal

    Amount of pramlintide (mcg) delivered in the 6 hours following the first meal.

    Measured: 6 hours following the first meal

  28. Median Amount of Pramlintide Delivered Following Second Meal

    Amount of pramlintide (mcg) delivered in the 6 hours following the second meal.

    Measured: 6 hours following the second meal

  29. Median Amount of Pramlintide Delivered

    Amount of pramlintide (mcg) delivered

    Measured: 12 hour clinic visit

  30. Coefficient of Variation Following First Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 * [standard deviation] / mean) of these values for the six hours following the meal.

    Measured: 6 hours following the first meal

  31. Coefficient of Variation Following Second Meal

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 * [standard deviation] / mean) of these values for the six hours following the meal.

    Measured: 6 hours following the second meal

  32. Coefficient of Variation

    Blood glucose values are recorded every 5 minutes using the Dexcom G6 sensor. The coefficient of variation outcome is calculated as (100 * [standard deviation] / mean) of these values for the twelve hours in the clinic.

    Measured: 12 hour clinic visit

  33. Low Blood Glucose Index (LBGI) Following the First Meal

    The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138

    Measured: 6 hours following the first meal

  34. Low Blood Glucose Index (LBGI) Following the Second Meal

    The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138

    Measured: 6 hours following the second meal

  35. Low Blood Glucose Index (LBGI)

    The Low Blood Glucose Index (LBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138

    Measured: 12 hour clinic visit

  36. High Blood Glucose Index (HBGI) Following the First Meal

    The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138

    Measured: 6 hours following the first meal

  37. High Blood Glucose Index (HBGI) Following the Second Meal

    The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138

    Measured: 6 hours following the second meal

  38. High Blood Glucose Index (HBGI)

    The High Blood Glucose Index (HBGI) was calculated and categorized following accepted methods as described in: Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(Suppl 1):S-45-S-54. doi:10.1089/dia.2008.0138

    Measured: 12 hour clinic visit

  39. Adverse Events Related to Pramlintide

    Assess the number of adverse events probably or possibly associated with pramlintide administration.

    Measured: 4 days of pramlintide use

  40. Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the First Meal

    Six hours after the meal, participants were asked to use the Baxter Retching Faces (BARF) visual analog scale to indicate the worst nausea/vomiting discomfort they felt over the prior 6 hours. The scale ranges from 0 (none) to 10 (most discomfort).

    Measured: 6 hours following first meal

  41. Baxter Retching Faces (BARF) Visual Analog Scale for Gastrointestinal Issues After the Second Meal

    Six hours after the meal, participants were asked to use the Baxter Retching Faces (BARF) visual analog scale to indicate the worst nausea/vomiting discomfort they felt over the prior 6 hours. The scale ranges from 0 (none) to 10 (most discomfort).

    Measured: 6 hours following second meal

  42. Mean Duration of Gastrointestinal Issues After the First Meal

    Six hours after the meal, participants were asked to report the approximate number of minutes they felt nausea during the prior 6 hours.

    Measured: 6 hours following first meal

  43. Mean Duration of Gastrointestinal Issues After the Second Meal

    Six hours after the meal, participants were asked to report the approximate number of minutes they felt nausea during the prior 6 hours.

    Measured: 6 hours following second meal

  44. Episodes of Hypoglycemia

    Counts of the number of episodes when the continuous glucose monitoring (CGM) values were <70 mg/dL for 10 minutes or more.

    Measured: 12 hour clinic visit

  45. Episodes of Carbohydrate Intake to Treat Hypoglycemia

    Assess the number of rescue carbohydrate treatments (defined as 15 grams of carbohydrate intake) needed to treat hypoglycemia.

    Measured: 12 hour clinic visit

  46. Number of Provider-administered Insulin Injections

    Assess the number of provider-administered insulin injections due to hyperglycemia.

    Measured: 12 hour clinic visit

Timeline

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

  1. First posted20 May 2024
  2. Study start12 Jul 2024
  3. Primary completion4 Jan 2025
  4. Study completion28 Jan 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06422325
Sponsor's protocol ID
STUDY00025279
Other IDs
5R01DK129382-03
Status last verified
Feb 2026
First submitted
15 May 2024
Last updated
9 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing MPC closed-loop system in insulin only mode and MPC closed-loop system in insulin/pramlintide mode in people with Type 1 Diabetes, run by Oregon Health and Science University at 1 site 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 8 inclusion and 24 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: finished, as of the sponsor's last update on 9 Jun 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 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incremental Area Under the Curve of Postprandial Glucose Following the First Meal (time frame: 6 hours following first meal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06422325.

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 9 Jun 2026.

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Clinical Trial NCT06422325 | AzTrials