| Trial ID: | L0080 |
| Source ID: | NCT05067621
|
| Associated Drug: |
Semaglutide
|
| Title: |
Semaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Not yet recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Type 2 Diabetes Mellitus|Impaired Glucose Tolerance|Non-Alcoholic Fatty Liver Disease|Obesity, Childhood
|
| Interventions: |
Drug: Semaglutide Pen Injector|Drug: Placebo
|
| Outcome Measures: |
Change in Oral Disposition Index (oDI)|Change in Protein Density Fat Fraction (PDFF)|Change in Oral glucose tolerance test (OGTT) derived biomarkers: oDI|Change in OGTT derived biomarkers: fasting insulin|Change in OGTT derived biomarkers: c-peptide|Change in OGTT derived biomarkers: fasting c-peptide|Time to glucose peak|Glucagon levels|Incretin effect|Fractional rates of de Novo Lipogenesis (DNL)|Total cholesterol|LDL cholesterol|HDL cholesterol|Triglycerides
|
| Sponsor/Collaborators: |
Yale University|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
All
|
| Age: |
10 Years to 21 Years ?? (Child, Adult)
|
| Phases: |
Phase 3
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
June 2022
|
| Completion Date: |
January 2027
|
| Results First Posted: |
--
|
| Last Update Posted: |
February 10, 2022
|
| Locations: |
--
|
| URL: |
https://ClinicalTrials.gov/show/NCT05067621
|
