Clinical Trial Details
| Trial ID: | L0072 |
| Source ID: | NCT04019561 |
| Associated Drug: | MEDI0382 |
| Title: | A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH. |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Non-alcoholic Fatty Liver Disease (NAFLD)|Non-alcoholic Steatohepatitis (NASH) |
| Interventions: | Drug: MEDI0382 high dose|Drug: Placebo for MEDI0382 high dose|Drug: MEDI0382 low dose|Drug: Placebo for MEDI0382 low dose |
| Outcome Measures: | To assess the safety (including hepatic safety) and tolerability of MEDI0382 compared with placebo|Change in hepatic fat|Change in liver volume|Change in liver fat volume|Change in visceral adipose tissue|Change in subcutaneous adipose tissue|Change in liver diffusion|Change in abdominal sagittal diameter (image based)|Change in abdominal transversal diameter (image based)|Change in circulating markers of hepatic inflammation|To assess the effect of MEDI0382 on BMI|To assess the dose response of MEDI0382 on HFF by MRI-PDFF|To assess the dose response of MEDI0382 on body weight|To assess the dose response of MEDI0382 on hepatic safety|To assess the dose response of MEDI0382 on imaging parameters.|To assess the dose response of MEDI0382 on circulating biomarkers of hepatic inflammation|Immunogenicity profile defined by presence of anti-drug antibodies (ADA) |
| Sponsor/Collaborators: | MedImmune LLC |
| Gender: | All |
| Age: | 18 Years to 101 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 74 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | September 23, 2019 |
| Completion Date: | May 6, 2021 |
| Results First Posted: | -- |
| Last Update Posted: | May 27, 2021 |
| Locations: | Research Site, Tucson, Arizona, United States|Research Site, Canoga Park, California, United States|Research Site, Chula Vista, California, United States|Research Site, Coronado, California, United States|Research Site, La Jolla, California, United States|Research Site, Lincoln, California, United States|Research Site, Los Angeles, California, United States|Research Site, Montclair, California, United States|Research Site, Oxnard, California, United States|Research Site, Panorama City, California, United States|Research Site, Torrance, California, United States|Research Site, Westminster, California, United States|Research Site, Colorado Springs, Colorado, United States|Research Site, Doral, Florida, United States|Research Site, Hialeah, Florida, United States|Research Site, Miami, Florida, United States|Research Site, Miami, Florida, United States|Research Site, Palmetto Bay, Florida, United States|Research Site, Columbus, Georgia, United States|Research Site, Marrero, Louisiana, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Durham, North Carolina, United States|Research Site, Blue Ash, Ohio, United States|Research Site, Chattanooga, Tennessee, United States|Research Site, Austin, Texas, United States|Research Site, Houston, Texas, United States|Research Site, Houston, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Fairfax, Virginia, United States|Research Site, Richmond, Virginia, United States|Research Site, San Juan, Puerto Rico |
| URL: | https://ClinicalTrials.gov/show/NCT04019561 |
