Type 2 Diabetes MellitusPhase 2NCT05067621
Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease
A Phase 2 study testing Semaglutide Pen Injector in people with Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to understand the role of GLP-1 in the pathogenesis of T2D in youth and explore their potential salutary effects and ability to delay the progressive loss of ß-cell function and reduce hepatic steatosis in youth with prediabetes/new onset T2D and NAFLD. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Impaired Glucose Tolerance, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Semaglutide Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects diagnosed with Pre-impaired glucose tolerance (pre-IGT) (2h glucose ≥ 130 mg/dl to ≤ 200 mg/dl post-OGTT) OR impaired glucose tolerance (2h glucose ≥140 to <200 mg/dl post-OGTT OR HbA1c ≥5.7% to <6.5%), OR new-onset T2D (≤24 months duration, 2h glucose >200 and HbA1c >6.5% to10%) treated with stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 12 months or less)
- PDFF of ≥ 8%
- Male or female, aged 10 to <21 years at the day of randomization, in puberty (pubertal stage will be assessed by pediatric Endocrinologists Dr. Samuels and Dr. Hu) (girls and boys: Tanner stage II-IV); girls who begin menstruating must have a negative pregnancy test during the study
- Weight ≥ 54kg
- BMI ≥ 85% but ≤ 40 kg/m2
- Good general health (normal kidney function, amylase, and lipase levels)
- Informed consent from a legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities (trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial)
- Ability and willingness to adhere to the protocol including self-measurement of plasma glucose according to the protocol.
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products.
- Receipt of any investigational medicinal product within 30 days before screening.
- Prepubertal participants (Tanner stage 1)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods.
- Having a diagnosis of:
- Type 1 diabetes o Maturity onset diabetes of the young (MODY) o History or presence of Pancreatitis (acute or chronic) o Presence of endocrinopathies (e.g., Cushing syndrome) o Cardiac, renal or pulmonary or other chronic illness o Known history of heart disease (including history of clinically significant arrhythmias or conduction delays on ECG, or new clinically significant arrhythmias or conduction delays on ECG identified at visit 1) o Family or personal history of MEN type 2 or medullary thyroid carcinoma (family is defined as a first-degree relative)o Any other disorder which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
Show all 24Show fewer
- Any laboratory safety parameter at screening outside the below extended laboratory ranges: o Baseline creatinine >1.0mg o Hypertriglyceridemia)(>500 mg/dl)
- Calcitonin equal or above 50 ng/L at screening o Body Mass Index (BMI) ≤ 25.0 at the screening visit o ALT ≥5 times the upper normal limit (UNL) o Creatinine >UNL for age in children unless renal function is proven normal by further assessments at the discretion of the investigator
- Known hypoglycemic unawareness.
- Recurrent severe hypoglycemic episodes within the last year as judged by the investigator.
- Uncontrolled hypertension treated or untreated >99th percentile for age and gender in children and adolescents.
- Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria in a period of 90 days before screening.
- Taking medication, based on the investigator's judgement, that may cause significant weight gain or loss (e.g., antipsychotic, steroid, anti-obesity medication).
- Presence or history of malignant neoplasm within 5 years prior to the day of screening.Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
- Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
- Mental health:
- History of major depressive disorder within 2 years before screening
- Diagnosis of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)
- A Patient Health Questionnaire-9 (PHQ-9) score of ≥15 at screening
- A lifetime history of suicidal attempt
- Suicidal behavior within 30 days before screening
- Suicidal ideation corresponding to type 4 or 5 based on the Columbia-Suicide Severity
- Rating Scale (C-SSRS) within the past 30 days before screening
- Participants with confirmed diagnosis of bulimia nervosa disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Diabetes Center
New Haven, Connecticut, 06511
About this study
Official title: Semaglutide, 2.4mg, Once Weekly: Effects on Beta-cell Preservation and Reduction of Intrahepatic Triglyceride Content in Obese Youth With Prediabetes (IGT)/Early Type 2 Diabetes (T2D) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
The purpose of this study is to understand the role of GLP-1 in the pathogenesis of T2D in youth and explore their potential salutary effects and ability to delay the progressive loss of ß-cell function and reduce hepatic steatosis in youth with prediabetes/new onset T2D and NAFLD.
Read the detailed description
In a recent publication by the TODAY Group Study, it was reported that "diabetes-related complications appear early in youth-onset T2D and accumulate rapidly at a mean age of 26.4 years," and 60.1% of participants developed at least one microvascular complication. The same has been reported in RISE Studies and was suggested that the rapid decline in β-cell function and its insensitivity to two of the most frequently used treatments for T2D in pediatrics is further aggravated by the rising prevalence in NAFLD. These alarming results indicate a pressing need for effective and innovative approaches at preserving β-cell function and reducing hepatic steatosis in obese youth in order to prevent disease progression and associated complications.
This study will provide mechanistic insights in support of a GLP-1 analog, Semaglutide, 2.4 mg weekly, therapy for prediabetes, new onset T2D and NAFLD in youth. The study design is a randomized, double-blind, placebo-controlled, clinical trial (RCT) using Semaglutie (Wegovy up to 2.4mg) for 6 months followed by a wash-out period of 3 months.
- Conditions
- Type 2 Diabetes Mellitus, Impaired Glucose Tolerance, Non-Alcoholic Fatty Liver Disease, Obesity, Childhood
- Being tested
- Semaglutide Pen Injector, Placebo
- Keywords
- Prediabetes, NAFLD, Impaired Glucose Tolerance, Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Non-alcoholic Fatty Liver Disease, Pediatric Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen InjectorDrug
Also called Wegovy
Semaglutide (Wegovy) pen is a subcutaneous injection that contains 2.4mg/0.75mL of active ingredient. The injection pen can deliver doses of 0.24mg, 0.5mg, 1.0mg, 1.7mg, and 2.4mg.
PlaceboDrug
Injection pen contains excipients.
| Study group | Role | What they receive |
|---|---|---|
| Receive treatment | Experimental | Semaglutide (Wegovy) pen is a subcutaneous injection Receives: Drug: Semaglutide Pen Injector |
| Placebo | Placebo comparator | The placebo pen is almost exactly the same as the Wegovy subcutaneous injection except it does not contain the active ingredient, Semaglutide. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Disposition Index (oDI)
The oDI value is the product of total responsivity index and insulin sensitivity. The change in oDI from baseline to 6M on treatment is calculated as the difference between 6M oDI value and baseline oDI value. The oDI measures the ability of beta-cell to respond to a glucose stimulus.
Measured: Baseline and 6 months
Change in Protein Density Fat Fraction (PDFF)
The change in PDFF from baseline to 6M on treatment is calculated as the difference between 6M PDFF value and Baseline PDFF. It provides an accurate, non-invasive, reproducible, quantitative, and precise estimation of liver fat content. The expected changes in MRI-PDFF from baseline to 6M is ≥ 5.8% reduction compared to the placebo group.
Measured: Baseline and 6 months
Secondary outcomes (27)
Change in Oral glucose tolerance test (OGTT) derived biomarkers: oDI
Change in oDI from baseline to 9M after the wash-out period, calculated as the difference between 9M oDI value and baseline oDI value. This is similar to Outcome 1 except measured at 9M.
Measured: Baseline and 9 months
Change in OGTT derived biomarkers: fasting insulin
Change in fasting insulin calculated as 1/Fasting Insulin [1/IF] from baseline to 6M.
Measured: Baseline and 6 months
Change in OGTT derived biomarkers: fasting insulin
Change in fasting insulin calculated as 1/Fasting Insulin [1/IF] from baseline to 9M.
Measured: Baseline and 9 months
Change in OGTT derived biomarkers: c-peptide
Change in c-peptide from baseline to 6M calculated as [change in C-peptide from 0-30min]
/[change in glucose from 0-30 min]. This computes for early c-peptide response to oral glucose.
Measured: Baseline and 6 months
Change in OGTT derived biomarkers: c-peptide
Change in c-peptide from baseline to 9M calculated as [change in C-peptide from 0-30min]
/[change in glucose from 0-30 min]. This computes for early c-peptide response to oral glucose.
Measured: Baseline and 9 months
Change in OGTT derived biomarkers: fasting c-peptide
Change in fasting c-peptide from baseline to 6M calculated as Fasting C-peptide/Fasting Insulin.
Measured: Baseline and 6 months
Change in OGTT derived biomarkers: fasting c-peptide
Change in fasting c-peptide from baseline to 9M calculated as Fasting C-peptide/Fasting Insulin.
Measured: Baseline and 9 months
Time to glucose peak
Identification of time to glucose peak during OGTT at baseline.
Measured: Baseline
Time to glucose peak
Identification of time to glucose peak during OGTT at 6M.
Measured: 6 months
Time to glucose peak
Identification of time to glucose peak during OGTT at 9M.
Measured: 9 months
Glucagon levels
Identification of glucagon levels during OGTT at baseline.
Measured: Baseline
Glucagon levels
Identification of glucagon levels during OGTT at 6M.
Measured: 6 months
Glucagon levels
Identification of glucagon levels during OGTT at 9M.
Measured: 9 months
Incretin effect
Estimated as the ratio between total insulin responses during OGTT and IVGTT at the end of treatment and expressed as percentage. It is computed by: [100% × (AUCins OGTT - AUCins IVGTT)/AUCins OGTT].
Measured: 6 months
Incretin effect
Estimated as the ratio between total insulin responses during OGTT and IVGTT at the end of the wash-out period and expressed as percentage. It is computed by: [100% × (AUCins OGTT - AUCins IVGTT)/AUCins OGTT].
Measured: 9 months
Change in Protein Density Fat Fraction (PDFF)
The change in PDFF from baseline to 9M after the wash-out period is calculated as the difference between 9M PDFF value and Baseline PDFF. It provides an accurate, non-invasive, reproducible, quantitative, and precise estimation of liver fat content. The expected changes in MRI-PDFF from baseline to 9M is ≥ 5.8% reduction compared to the placebo group.
Measured: Baseline and 9 months
Fractional rates of de Novo Lipogenesis (DNL)
It is the measure of contribution of hepatic DNL and plasma free fatty acid reesterification to plasma triglyceride secretion at baseline. It is calculated by F = plasma palmitate enrichment/(22 X plasma deuterium enrichment). F is the fraction of palmitate synthesized during the time between the loading dose of the deuterium-labeled water and the collection time.
Measured: Baseline
Fractional rates of de Novo Lipogenesis (DNL)
It is the measure of contribution of hepatic DNL and plasma free fatty acid reesterification to plasma triglyceride secretion at 6M. It is calculated by F = plasma palmitate enrichment/(22 X plasma deuterium enrichment). F is the fraction of palmitate synthesized during the time between the loading dose of the deuterium-labeled water and the collection time.
Measured: 6 months
Fractional rates of de Novo Lipogenesis (DNL)
It is the measure of contribution of hepatic DNL and plasma free fatty acid reesterification to plasma triglyceride secretion at 9M. It is calculated by F = plasma palmitate enrichment/(22 X plasma deuterium enrichment). F is the fraction of palmitate synthesized during the time between the loading dose of the deuterium-labeled water and the collection time.
Measured: 9 months
Total cholesterol
Measure of total cholesterol in plasma taken at 6M.
Measured: 6 months
Total cholesterol
Measure of total cholesterol in plasma taken at 9M.
Measured: 9 months
LDL cholesterol
Measure of LDL cholesterol in plasma taken at 6M.
Measured: 6 months
LDL cholesterol
Measure of LDL cholesterol in plasma taken at 9M.
Measured: 9 months
HDL cholesterol
Measure of HDL cholesterol in plasma taken at 6M.
Measured: 6 months
HDL cholesterol
Measure of LDL cholesterol in plasma taken at 9M.
Measured: 9 months
Triglycerides
Measures of triglycerides in plasma taken at 6M.
Measured: 6 months
Triglycerides
Measures of triglycerides in plasma taken at 9M.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start17 Jul 2023
- Primary completionDec 2026 (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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Yale 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will undergo baseline tests at the beginning of the study and will be randomized to receive experimental drug or placebo. Dose escalation will be achieved within 16 weeks to reach up to 2.4mg of Semaglutide, weekly, which they will be on for 6 months. All tests will be repeated after 6 months of treatment followed by a wash-out period of 3 months, after which the same tests will be repeated.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Caprio, Yale University
- Investigators
- Sonia Caprio, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067621
- Sponsor's protocol ID
- 2000031181
- Other IDs
- 2R01DK111038-06A1
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide, 2.4mg, Once Weekly: Effects on Beta-cell Preservation and Reduction of Intrahepatic Triglyceride Content in Obese Youth With Prediabetes (IGT)/Early Type 2 Diabetes (T2D) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- ClinicalTrials.gov ID
- NCT05067621
- Acronym / sponsor ID
- 2000031181
- Conditions
- Type 2 Diabetes Mellitus, Impaired Glucose Tolerance, Non-Alcoholic Fatty Liver Disease, Obesity, Childhood
- Keywords
- Prediabetes, NAFLD, Impaired Glucose Tolerance, Semaglutide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand the role of GLP-1 in the pathogenesis of T2D in youth and explore their potential salutary effects and ability to delay the progressive loss of ß-cell function and reduce hepatic steatosis in youth with prediabetes/new onset T2D and NAFLD.
Detailed description
In a recent publication by the TODAY Group Study, it was reported that "diabetes-related complications appear early in youth-onset T2D and accumulate rapidly at a mean age of 26.4 years," and 60.1% of participants developed at least one microvascular complication. The same has been reported in RISE Studies and was suggested that the rapid decline in β-cell function and its insensitivity to two of the most frequently used treatments for T2D in pediatrics is further aggravated by the rising prevalence in NAFLD. These alarming results indicate a pressing need for effective and innovative approaches at preserving β-cell function and reducing hepatic steatosis in obese youth in order to prevent disease progression and associated complications.
This study will provide mechanistic insights in support of a GLP-1 analog, Semaglutide, 2.4 mg weekly, therapy for prediabetes, new onset T2D and NAFLD in youth. The study design is a randomized, double-blind, placebo-controlled, clinical trial (RCT) using Semaglutie (Wegovy up to 2.4mg) for 6 months followed by a wash-out period of 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will undergo baseline tests at the beginning of the study and will be randomized to receive experimental drug or placebo. Dose escalation will be achieved within 16 weeks to reach up to 2.4mg of Semaglutide, weekly, which they will be on for 6 months. All tests will be repeated after 6 months of treatment followed by a wash-out period of 3 months, after which the same tests will be repeated.
| Arm | Type | Receives |
|---|---|---|
| Receive treatment | Experimental | Drug: Semaglutide Pen InjectorSemaglutide (Wegovy) pen is a subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo pen is almost exactly the same as the Wegovy subcutaneous injection except it does not contain the active ingredient, Semaglutide. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Subjects diagnosed with Pre-impaired glucose tolerance (pre-IGT) (2h glucose ≥ 130 mg/dl to ≤ 200 mg/dl post-OGTT) OR impaired glucose tolerance (2h glucose ≥140 to <200 mg/dl post-OGTT OR HbA1c ≥5.7% to <6.5%), OR new-onset T2D (≤24 months duration, 2h glucose >200 and HbA1c >6.5% to10%) treated with stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 12 months or less)
- PDFF of ≥ 8%
- Male or female, aged 10 to <21 years at the day of randomization, in puberty (pubertal stage will be assessed by pediatric Endocrinologists Dr. Samuels and Dr. Hu) (girls and boys: Tanner stage II-IV); girls who begin menstruating must have a negative pregnancy test during the study
- Weight ≥ 54kg
- BMI ≥ 85% but ≤ 40 kg/m2
Key exclusion criteria (24 listed)
- Known or suspected hypersensitivity to trial product(s) or related products.
- Receipt of any investigational medicinal product within 30 days before screening.
- Prepubertal participants (Tanner stage 1)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods.
- Having a diagnosis of:
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 |
|---|---|---|
| Semaglutide Pen InjectorAlso: WegovySemaglutide (Wegovy) pen is a subcutaneous injection that contains 2.4mg/0.75mL of active ingredient. The injection pen can deliver doses of 0.24mg, 0.5mg, 1.0mg, 1.7mg, and 2.4mg. | Drug | Receive treatment |
| PlaceboInjection pen contains excipients. | Drug | Placebo |
Primary outcome
Change in Oral Disposition Index (oDI)
Time frame: Baseline and 6 months
The oDI value is the product of total responsivity index and insulin sensitivity. The change in oDI from baseline to 6M on treatment is calculated as the difference between 6M oDI value and baseline oDI value. The oDI measures the ability of beta-cell to respond to a glucose stimulus.
Change in Protein Density Fat Fraction (PDFF)
Time frame: Baseline and 6 months
The change in PDFF from baseline to 6M on treatment is calculated as the difference between 6M PDFF value and Baseline PDFF. It provides an accurate, non-invasive, reproducible, quantitative, and precise estimation of liver fat content. The expected changes in MRI-PDFF from baseline to 6M is ≥ 5.8% reduction compared to the placebo group.
27 secondary outcomes
Change in Oral glucose tolerance test (OGTT) derived biomarkers: oDI
Time frame: Baseline and 9 months
Change in OGTT derived biomarkers: fasting insulin
Time frame: Baseline and 6 months
Change in OGTT derived biomarkers: fasting insulin
Time frame: Baseline and 9 months
Change in OGTT derived biomarkers: c-peptide
Time frame: Baseline and 6 months
Change in OGTT derived biomarkers: c-peptide
Time frame: Baseline and 9 months
Change in OGTT derived biomarkers: fasting c-peptide
Time frame: Baseline and 6 months
Change in OGTT derived biomarkers: fasting c-peptide
Time frame: Baseline and 9 months
Time to glucose peak
Time frame: Baseline
Time to glucose peak
Time frame: 6 months
Time to glucose peak
Time frame: 9 months
Glucagon levels
Time frame: Baseline
Glucagon levels
Time frame: 6 months
Glucagon levels
Time frame: 9 months
Incretin effect
Time frame: 6 months
Incretin effect
Time frame: 9 months
Change in Protein Density Fat Fraction (PDFF)
Time frame: Baseline and 9 months
Fractional rates of de Novo Lipogenesis (DNL)
Time frame: Baseline
Fractional rates of de Novo Lipogenesis (DNL)
Time frame: 6 months
Fractional rates of de Novo Lipogenesis (DNL)
Time frame: 9 months
Total cholesterol
Time frame: 6 months
Total cholesterol
Time frame: 9 months
LDL cholesterol
Time frame: 6 months
LDL cholesterol
Time frame: 9 months
HDL cholesterol
Time frame: 6 months
HDL cholesterol
Time frame: 9 months
Triglycerides
Time frame: 6 months
Triglycerides
Time frame: 9 months
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 Apr 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. This study is not recruiting at the moment.
Sonia Caprio, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide Pen Injector in people with Type 2 Diabetes Mellitus and Impaired Glucose Tolerance, run by Yale 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Change in Oral Disposition Index (oDI) (time frame: Baseline and 6 months). 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?
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 Apr 2026.