Clinical Trial Details
| Trial ID: | L0204 |
| Source ID: | NCT04880031 |
| Associated Drug: | BOS-580 |
| Title: | A Study of BOS-580 in Obese Subjects at Risk for Nonalcoholic Steatohepatitis (NASH) |
| Acronym: | -- |
| Status: | Recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Nonalcoholic Steatohepatitis (NASH) |
| Interventions: | Drug: BOS-580|Drug: Placebo |
| Outcome Measures: | Number of participants with treatment-emergent adverse events (TEAE) and treatment-emergent serious adverse events (TESAE)|Changes from Baseline to Week 12 (Day 85) in systolic and diastolic blood pressure (BP)|Changes from Baseline to Week 12 (Day 85) in heart rate|Number of participants with Grade 3-4 laboratory abnormalities at Week 12 (Day 85)|Maximum serum drug concentration (Cmax) for BOS-580|Minimum serum drug concentration (Cmin) for BOS-580|Average serum drug concentration (Cavg) for BOS-580|Time to reach maximum serum concentration (Tmax) for BOS-580|Area under the serum concentration-time curve (AUC) from time zero to time of last measurable concentration (AUClast) for BOS-580|Area under the serum concentration-time curve during a dosage interval (AUCtau) for BOS-580 |
| Sponsor/Collaborators: | Boston Pharmaceuticals |
| Gender: | All |
| Age: | 18 Years to 75 Years ?? (Adult, Older Adult) |
| Phases: | Phase 2 |
| Enrollment: | 75 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment |
| Start Date: | September 30, 2021 |
| Completion Date: | August 2023 |
| Results First Posted: | -- |
| Last Update Posted: | February 18, 2022 |
| Locations: | Central Research Associates, Birmingham, Alabama, United States|QLMC, Tucson, Arizona, United States|Catalina Research Institute, Montclair, California, United States|Southwest General Healthcare Center, Fort Myers, Florida, United States|Galenus Group, Lehigh Acres, Florida, United States|Panex Clinical Research, Miami Lakes, Florida, United States|Century Research, Miami, Florida, United States|Lovelace, Albuquerque, New Mexico, United States|Lillestol Research LLC, Fargo, North Dakota, United States|Accelemed Research, Austin, Texas, United States|Olympus Family Medicine, Salt Lake City, Utah, United States|South Ogden Family Medicine, South Ogden, Utah, United States|Liver Institute NorthWest, Seattle, Washington, United States |
| URL: | https://ClinicalTrials.gov/show/NCT04880031 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D472 | BOS-580 | Chemical drug | -- | -- | -- | 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 |
| D223 | Metabolic Cofactor Supplementation | Supplement | -- | -- | -- | Under clinical trials | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |