Clinical Trial Details
| Trial ID: | L0057 |
| Source ID: | NCT04216589 |
| Associated Drug: | Semaglutide |
| Title: | Study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome With Insulin Resistance, Increased Hepatic Lipids, and Increased Cardiovascular Disease Risk (The SLIM LIVER Study) |
| Acronym: | -- |
| Status: | Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | HIV Infections|Non-Alcoholic Fatty Liver Disease |
| Interventions: | Drug: Semaglutide |
| Outcome Measures: | Change (absolute) in IHTG (%)|Change (percent) in IHTG (%)|Change (absolute) in body mass index (BMI)|Change (absolute) in body weight|Change (absolute) in minimum waist circumference (WC)|Level of IHTG (%)|Occurrence of premature discontinuation of study treatment|Occurrence of Grade ???3 adverse event that are related to study treatment|Change (absolute) in insulin resistance (HOMA-IR)|Change (absolute) in glucose|Change (absolute) in lipid profiles (triglycerides, HDL cholesterol, LDL cholesterol, and total cholesterol)|Presence of metabolic syndrome |
| Sponsor/Collaborators: | National Institute of Allergy and Infectious Diseases (NIAID)|The University of Texas Health Science Center, Houston |
| Gender: | All |
| Age: | 18 Years and older ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 50 |
| Study Type: | Interventional |
| Study Designs: | Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| Start Date: | October 1, 2020 |
| Completion Date: | December 15, 2023 |
| Results First Posted: | -- |
| Last Update Posted: | January 31, 2022 |
| Locations: | Alabama CRS (Site ID: 31788), Birmingham, Alabama, United States|University of Colorado Hospital CRS (Site ID: 6101), Aurora, Colorado, United States|Johns Hopkins University CRS, Baltimore, Maryland, United States|Massachusetts General Hospital CRS (MGH CRS) (Site ID: 101), Boston, Massachusetts, United States|Cincinnati Clinical Research Site (Site ID: 2401), Cincinnati, Ohio, United States|Ohio State University CRS (Site ID: 2301), Columbus, Ohio, United States|Houston AIDS Research Team CRS (Site ID: 31473), Houston, Texas, United States|University of Washington AIDS CRS (Site ID: 1401), Seattle, Washington, United States|Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID: 12101), Rio de Janeiro, Brazil |
| URL: | https://ClinicalTrials.gov/show/NCT04216589 |
