Clinical Trial Details
| Trial ID: | L0077 |
| Source ID: | NCT03467217 |
| Associated Drug: | Losartan |
| Title: | Losartan for the Treatment of Pediatric NAFLD |
| Acronym: | STOP-NAFLD |
| Status: | Terminated |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT03467217/results |
| Conditions: | NAFLD - Nonalcoholic Fatty Liver Disease |
| Interventions: | Drug: Losartan potassium|Drug: Placebo losartan capsule |
| Outcome Measures: | Change in Serum Alanine Aminotransferase (ALT) From Baseline.|Change in Gamma-glutamyl Transpeptidase (GGT) Compared to Baseline|Change in Serum Aspartate Aminotransferase AST at 24 Weeks Compared to Baseline AST|Relative Change in Serum Alanine Aminotransferase (ALT) Compared to Baseline ALT|Change in ALT at 12 Weeks Compared to Baseline ALT|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Compared to Baseline.|Change in Weight at 24 Weeks Compared to Baseline|Change in Body Mass Index (BMI) at 24 Weeks Compared to Baseline.|Change in Waist Circumference at 24 Weeks Compared to Baseline|Change in Waist-to-hip Ratio at 24 Weeks Compared to Baseline|Change in Pediatric Quality of Life Inventory (PedsQOL) Physical Health Score at 24 Weeks Compared to Baseline|Frequency of Adverse Events Over 24 Weeks|Change in Total Cholesterol at 24 Weeks Compared to Baseline|Change in Triglycerides at 24 Weeks Compared to Baseline|Change in HDL Cholesterol at 24 Weeks Compared to Baseline|Change in LDL Cholesterol at 24 Weeks Compared to Baseline|Change in Pediatric Quality of Life Inventory (PedsQOL) Psychosocial Health Score at 24 Weeks Compared to Baseline |
| Sponsor/Collaborators: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|Johns Hopkins University |
| Gender: | All |
| Age: | 8 Years to 17 Years ?? (Child) |
| Phases: | Phase 2 |
| Enrollment: | 83 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment |
| Start Date: | October 2, 2018 |
| Completion Date: | June 30, 2020 |
| Results First Posted: | October 21, 2021 |
| Last Update Posted: | October 21, 2021 |
| Locations: | University of California, San Diego, San Diego, California, United States|University of California, San Francisco, San Francisco, California, United States|Emory University, Atlanta, Georgia, United States|Northwestern Univ-Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States|Indiana University, Indianapolis, Indiana, United States|St. Louis University, Saint Louis, Missouri, United States|Columbia University, New York, New York, United States|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States|Texas Children's Hospital, Houston, Texas, United States|University of Washington, Seattle, Washington, United States |
| URL: | https://ClinicalTrials.gov/show/NCT03467217 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D209 | Losartan | Chemical drug | DB00678 | AGTR1 antagonist&binder | Anti-fibrosis | Under clinical trials | Details |
| D182 | Insulin | Biological drug | DB00030 | INSR agonist; CPE modulator&product of | -- | Under clinical trials | Details |
| D199 | L-alanine | Chemical drug | DB00160 | KYNU | -- | Failed in clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |