| Trial ID: | L3930 |
| Source ID: | NCT06005012
|
| Associated Drug: |
Semaglutide
|
| Title: |
Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM
|
| Acronym: |
SAMARA
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Fibrosis, Liver|Type 2 Diabetes Mellitus in Obese|Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
DRUG: Semaglutide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in fibrosis due to NAFLD, Change in fibrosis due to Nonalcoholic fatty liver disease (NAFLD), as measured by change in FAST Score, which combines FibroScan results with aspartate aminotransferase (AST)., 52 weeks | Secondary: Change in liver stiffness, Change in liver stiffness, as measured by change in Vibration-Controlled Transient Elastography, 52 weeks|Change in steatosis, Change in steatosis, as measure by a change in proton density fat fraction or controlled attenuation parameter, 52 weeks|Change in ALT, Change in ALT, as measured by a change in patients with ALT \>= 30 U/L at baseline, 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of California, San Diego
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-07-25
|
| Completion Date: |
2025-06
|
| Results First Posted: |
|
| Last Update Posted: |
2023-09-07
|
| Locations: |
University of California, San Diego, La Jolla, California, 92093, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06005012
|
