Clinical Trial Details
| Trial ID: | L0262 |
| Source ID: | NCT02913105 |
| Associated Drug: | LMB763 |
| Title: | Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH |
| Acronym: | -- |
| Status: | Terminated |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT02913105/results |
| Conditions: | Non-alcoholic Steatohepatitis NASH |
| Interventions: | Drug: LMB763|Drug: Placebo |
| Outcome Measures: | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Change From Baseline in Alanine Aminotransferase (ALT) Levels|Observed Maximum Plasma Concentration (Cmax) of LMB763|Time to Reach Maximum Concentration (Tmax) of LMB763|Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763|Accumulation Ratio (Racc) of LMB763|Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)|Change From Baseline in Weight|Change From Baseline in Body Mass Index (BMI)|Change From Baseline in Waist to Hip Ratio|Change From to Baseline in Liver Stiffness|Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel|Change From Baseline in Fibrosis Biomarker Test|Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)|Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol|Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin |
| Sponsor/Collaborators: | Novartis Pharmaceuticals|Novartis |
| Gender: | All |
| Age: | 18 Years and older ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 122 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment |
| Start Date: | October 24, 2016 |
| Completion Date: | September 19, 2018 |
| Results First Posted: | November 26, 2019 |
| Last Update Posted: | January 5, 2021 |
| Locations: | Novartis Investigative Site, Culver City, California, United States|Novartis Investigative Site, Cypress, California, United States|Novartis Investigative Site, Gainesville, Florida, United States|Novartis Investigative Site, Miami Springs, Florida, United States|Novartis Investigative Site, Orlando, Florida, United States|Novartis Investigative Site, Orlando, Florida, United States|Novartis Investigative Site, Honolulu, Hawaii, United States|Novartis Investigative Site, Baton Rouge, Louisiana, United States|Novartis Investigative Site, Boston, Massachusetts, United States|Novartis Investigative Site, High Point, North Carolina, United States|Novartis Investigative Site, Nashville, Tennessee, United States|Novartis Investigative Site, Arlington, Texas, United States|Novartis Investigative Site, Houston, Texas, United States|Novartis Investigative Site, Newport News, Virginia, United States|Novartis Investigative Site, New Lambton, New South Wales, Australia|Novartis Investigative Site, Nedlands, Western Australia, Australia|Novartis Investigative Site, Tbilisi, Georgia|Novartis Investigative Site, Amman, Jordan|Novartis Investigative Site, Papatoetoe, Auckland, New Zealand|Novartis Investigative Site, Auckland, New Zealand|Novartis Investigative Site, Christchurch, New Zealand|Novartis Investigative Site, Tauranga, New Zealand|Novartis Investigative Site, Wellington, New Zealand|Novartis Investigative Site, San Juan, Puerto Rico|Novartis Investigative Site, Bern, Switzerland|Novartis Investigative Site, Geneve 14, Switzerland|Novartis Investigative Site, Lugano, Switzerland|Novartis Investigative Site, Plymouth, Devon, United Kingdom|Novartis Investigative Site, Glasgow, United Kingdom|Novartis Investigative Site, Portsmouth, United Kingdom |
| URL: | https://ClinicalTrials.gov/show/NCT02913105 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D241 | Nidufexor | Chemical drug | DB16255 | FXR modulator | Enhance lipid metabolism | 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 |