Clinical Trial Details
| Trial ID: | L0275 |
| Source ID: | NCT04685993 |
| Associated Drug: | LPCN 1144 |
| Title: | A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial |
| Acronym: | -- |
| Status: | Active, not recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | NASH - Nonalcoholic Steatohepatitis |
| Interventions: | Drug: LPCN 1144 |
| Outcome Measures: | Measure the safety and tolerability of LPCN 1144 by assessing the number of treatment-related adverse events|Measure the effect of LPCN 1144 on liver injury markers|Measure the effect of LPCN 1144 on serum lipid panels|Measure the effect of LPCN 1144 on hematology panels|Measure the safety and tolerability of LPCN 1144 by assessing changes in patient-reported disease severity using the PGI-S questionnaire |
| Sponsor/Collaborators: | Lipocine Inc. |
| Gender: | Male |
| Age: | Child, Adult, Older Adult |
| Phases: | Phase 2 |
| Enrollment: | 20 |
| Study Type: | Interventional |
| Study Designs: | Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
| Start Date: | November 11, 2020 |
| Completion Date: | August 2022 |
| Results First Posted: | -- |
| Last Update Posted: | February 14, 2022 |
| Locations: | Clinical Trials Research, Roseville, California, United States|Sensible Healthcare, LLC, Ocoee, Florida, United States|Jubilee Clinical Research, Inc., Las Vegas, Nevada, United States|R&H Clinical Research, Katy, Texas, United States|Sun Research Institute, San Antonio, Texas, United States|Endeavor Clinical Trials, San Antonio, Texas, United States|Pioneer Research Soultions, Sugar Land, Texas, United States|Advanced Clinical Research - Gut Whisperer, Riverton, Utah, United States|Granger Medical Clinic, West Valley City, Utah, United States|Manassas Clinical Research Center, Manassas, Virginia, United States |
| URL: | https://ClinicalTrials.gov/show/NCT04685993 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D211 | LPCN 1144 | Biological drug | -- | AR activator | Metabolic disorder drug | 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 |