Clinical Trial Details
| Trial ID: | L0069 |
| Source ID: | NCT01811472 |
| Associated Drug: | LCQ908 |
| Title: | Study to Assess the Efficacy, Safety and Tolerability of LCQ908 in NAFLD Patients |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT01811472/results |
| Conditions: | Non-alcoholic Fatty Liver Disease (NAFLD) |
| Interventions: | Drug: LCQ908|Drug: placebo |
| Outcome Measures: | Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24|Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12|Percentage of Responders at Week 12|Percentage of Responders at Week 24|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24|Percentage of Patients With Normalized Liver Enzymes|Percent Change From Baseline in Fasting Triglycerides|Post-prandial Peak Triglycerides Over 0 - 8 Hours|Change From Baseline in Body Weight|Change From Baseline in Waist Circumference|Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability |
| Sponsor/Collaborators: | Novartis Pharmaceuticals|Novartis |
| Gender: | All |
| Age: | 18 Years to 74 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 52 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | June 2013 |
| Completion Date: | September 2014 |
| Results First Posted: | February 4, 2016 |
| Last Update Posted: | February 4, 2016 |
| Locations: | Novartis Investigative Site, Mobile, Alabama, United States|Novartis Investigative Site, San Diego, California, United States|Novartis Investigative Site, Gainesville, Florida, United States|Novartis Investigative Site, Miami, Florida, United States|Novartis Investigative Site, Tamarac, Florida, United States|Novartis Investigative Site, Honolulu, Hawaii, United States|Novartis Investigative Site, Louisville, Kentucky, United States|Novartis Investigative Site, Tupelo, Mississippi, United States|Novartis Investigative Site, Houston, Texas, United States|Novartis Investigative Site, Plano, Texas, United States|Novartis Investigative Site, Richmond, Virginia, United States |
| URL: | https://ClinicalTrials.gov/show/NCT01811472 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D202 | LCQ908 | Chemical drug | DB12866 | DGAT1 inhibitor | Hypolipidemic drug | 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 |