Clinical Trial Details
| Trial ID: | L0037 |
| Source ID: | NCT04147195 |
| Associated Drug: | Tropifexor |
| Title: | Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH) |
| Acronym: | NEXSCOT |
| Status: | Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Non-alcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis |
| Interventions: | Drug: LYS006|Drug: LYS006 + Tropifexor (LJN452) |
| Outcome Measures: | Number of Participants with Treatment Related Adverse Events, Serious Adverse Events and Deaths|Change from Baseline in Enhanced Liver Fibrosis (ELF)|Change from Baseline in percent liver fat|Change from Baseline in fasting lipid profile|Change from Baseline in Alanine aminotransferase (ALT)|Determine the Area Under the Curve (AUC) of treatments|Determine the minimum concentration (Cmin) of treatments|Determine the maximum concentration (Cmax) of treatments|Determine the time to reach the maximum concentration (Tmax) for the treatments |
| Sponsor/Collaborators: | Novartis Pharmaceuticals|Novartis |
| Gender: | All |
| Age: | 18 Years and older ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 250 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| Start Date: | June 4, 2020 |
| Completion Date: | July 31, 2022 |
| Results First Posted: | -- |
| Last Update Posted: | February 28, 2022 |
| Locations: | Novartis Investigative Site, Coronado, California, United States|Novartis Investigative Site, Los Angeles, California, United States|Novartis Investigative Site, Los Angeles, California, United States|Novartis Investigative Site, Miami Lakes, Florida, United States|Novartis Investigative Site, Saint Petersburg, Florida, United States|Novartis Investigative Site, Marietta, Georgia, United States|Novartis Investigative Site, Honolulu, Hawaii, United States|Novartis Investigative Site, South Bend, Indiana, United States|Novartis Investigative Site, Wichita, Kansas, United States|Novartis Investigative Site, Morehead City, North Carolina, United States|Novartis Investigative Site, Dallas, Texas, United States|Novartis Investigative Site, Denison, Texas, United States|Novartis Investigative Site, San Antonio, Texas, United States|Novartis Investigative Site, Waco, Texas, United States|Novartis Investigative Site, Caba, Buenos Aires, Argentina|Novartis Investigative Site, Buenos Aires, Argentina|Novartis Investigative Site, Essen, Nordrhine Westphalia, Germany|Novartis Investigative Site, Dresden, Germany|Novartis Investigative Site, Frankfurt, Germany|Novartis Investigative Site, Mainz, Germany |
| URL: | https://ClinicalTrials.gov/show/NCT04147195 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D379 | Tropifexor | Chemical drug | DB16343 | FXR agonist | Enhance lipid metabolism | Under clinical trials | Details |
| D010 | Amoxicillin | Chemical drug | DB01060 | -- | -- | Under clinical trials | Details |
| D199 | L-alanine | Chemical drug | DB00160 | KYNU | -- | Failed in clinical trials | Details |
| D214 | LYS006 | Chemical drug | -- | -- | -- | Under clinical trials | Details |
| D223 | Metabolic Cofactor Supplementation | Supplement | -- | -- | -- | Under clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |