Clinical Trial Details
| Trial ID: | L0175 |
| Source ID: | NCT03205150 |
| Associated Drug: | LIK066 |
| Title: | Effect of LIK066 on Reduction of Fatty Content in Livers of Obese Patients |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT03205150/results |
| Conditions: | Obese Patients With Non-alcoholic Steatohepatitis (NASH) |
| Interventions: | Drug: LIK066|Drug: Placebo |
| Outcome Measures: | Change From Baseline in Alanine Aminotransferase (ALT) at Week 12|Change From Baseline in Percent Liver Fat at Week 12|Percent Change From Baseline in Total Body Weight at Week 12|Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Week 12|Change From Baseline in the Concentration of Hyaluronic Acid at Week 12.|Change From Baseline in the Concentration of Procollagen Type Iii N-Terminal Peptide (PIIINP) at Week 12.|Change From Baseline in the Concentration of Tissue Inhibitor Of Metalloproteinase 1 (TIMP-1) at Week 12.|Pharmacokinetics of LIK066: Observed Maximum Plasma Concentration (Cmax) Following Drug Administration|Pharmacokinetics of LIK066: Observed Maximum Time Duration of Maximum Concentration (Tmax) Following Drug Administration|Pharmacokinetics of LIK066: Observed Area Under the Curve up to the Last Measurable Concentration (AUClast) Following Drug Administration|Change From Baseline in Aspartate Aminotransferase (AST) at Week 12 |
| Sponsor/Collaborators: | Novartis Pharmaceuticals|Novartis |
| Gender: | All |
| Age: | 18 Years and older ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 107 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment |
| Start Date: | October 4, 2017 |
| Completion Date: | November 14, 2019 |
| Results First Posted: | January 6, 2021 |
| Last Update Posted: | October 8, 2021 |
| Locations: | Novartis Investigative Site, Baton Rouge, Louisiana, United States|Novartis Investigative Site, Saint Louis, Missouri, United States|Novartis Investigative Site, Knoxville, Tennessee, United States|Novartis Investigative Site, Live Oak, Texas, United States|Novartis Investigative Site, Caba, Buenos Aires, Argentina|Novartis Investigative Site, Buenos Aires, Argentina|Novartis Investigative Site, Montreal, Quebec, Canada|Novartis Investigative Site, Haifa, Israel|Novartis Investigative Site, Ramat Gan, Israel|Novartis Investigative Site, Tel Aviv, Israel|Novartis Investigative Site, Leiden, Netherlands|Novartis Investigative Site, St-Petersburg, Russian Federation|Novartis Investigative Site, Chia-Yi, Taiwan|Novartis Investigative Site, Tainan, Taiwan|Novartis Investigative Site, Bangkok, Thailand |
| URL: | https://ClinicalTrials.gov/show/NCT03205150 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D204 | Licogliflozin | Chemical drug | DB15048 | SGLT1 inhibitor; SGLT2 inhibitor | Improve insulin resistance | Under clinical trials | Details |
| D010 | Amoxicillin | Chemical drug | DB01060 | -- | -- | Under clinical trials | Details |
| D083 | CLA | Chemical drug | DB01211 | KCNH2; SLCO1B1; SLCO1B3 | -- | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D199 | L-alanine | Chemical drug | DB00160 | KYNU | -- | Failed in 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 |