Clinical Trial Details
| Trial ID: | L0336 |
| Source ID: | NCT03656744 |
| Associated Drug: | HTD1801 |
| Title: | A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) |
| Acronym: | -- |
| Status: | Completed |
| Study Results: | Has Results |
| Results: | https://ClinicalTrials.gov/show/NCT03656744/results |
| Conditions: | Fatty Liver, Nonalcoholic|NAFLD|Nonalcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis|Digestive System Diseases|Type 2 Diabetes Mellitus (T2DM) |
| Interventions: | Drug: HTD1801|Drug: Placebo |
| Outcome Measures: | Absolute Change in Liver Fat Content (LFC) as Measured by MRI-PDFF|Change in Fasting Glucose|Changes in Hemoglobin A1c|Proportion of Subjects Who Achieved ??? 30% Relative Reduction in LFC as Measured by MRI-PDFF|Relative Change in LFC as Measured by MRI-PDFF|Number of Subjects Who Normalized LFC to <5% as Measured by MRI-PDFF|Number of Subjects Who Achieved ???5% Absolute Reduction in Liver Fat Content (LFC) as Measured by MRI-PDFF|Change in HOMA-IR|Change in LDL-c|Change in Serum Triglycerides|Change in HDL-c|Change in AST|Change in ALT|Proportion of Subjects With Elevated ALT at Baseline Who Normalized ALT at Week 18|Change in Pro-Peptide of Type III Collagen (Pro-C3)|Change in ELF Score|Change in TIMP-1|Change in PIIINP|Change in HA|Change in Total Bile Acids|Change in FGF19|Number of Participants Reporting an Adverse Events From Baseline Through Week 18 |
| Sponsor/Collaborators: | HighTide Biopharma Pty Ltd |
| Gender: | All |
| Age: | 18 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 101 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | November 26, 2018 |
| Completion Date: | March 9, 2020 |
| Results First Posted: | December 29, 2021 |
| Last Update Posted: | December 29, 2021 |
| Locations: | Institute for Liver Health, Chandler, Arizona, United States|Institute for Liver Health, Tucson, Arizona, United States|Adobe Clinical Research, Tucson, Arizona, United States|National Research Institute, Panorama City, California, United States|Excel Medical Clinical Trials, Boca Raton, Florida, United States|Florida Research Institute, Lakewood Ranch, Florida, United States|Compass Research, Orlando, Florida, United States|Kansas City Research Institute, Kansas City, Missouri, United States|Cumberland Research Associates, Fayetteville, North Carolina, United States|Gastro One, Germantown, Tennessee, United States|Digestive Health Research, Hermitage, Tennessee, United States|Pinnacle Clinical Research, Austin, Texas, United States|Doctors Hospital at Renaissance, Edinburg, Texas, United States|Pinnacle Clinical Research, San Antonio, Texas, United States|Texas Digestive Disease Consultants, Southlake, Texas, United States|Harborview Medical Center, Seattle, Washington, United States|University of Washington Medical Center, Seattle, Washington, United States |
| URL: | https://ClinicalTrials.gov/show/NCT03656744 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D174 | HTD1801 | Chemical drug | -- | lipid modulator | Anticholesteremic; Anti-inflammatories; Antihyperlipidaemics; Hepatoprotectants | 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 |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |