Clinical Trial Details
| Trial ID: | L0170 |
| Source ID: | NCT04565717 |
| Associated Drug: | ALN-HSD |
| Title: | A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) |
| Acronym: | -- |
| Status: | Active, not recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | Nonalcoholic Steatohepatitis|NASH |
| Interventions: | Drug: ALN-HSD|Drug: Placebo |
| Outcome Measures: | Frequency of Adverse Events|Area Under the Plasma Concentration-time Curve (AUC) for ALN-HSD and Potential Metabolites|Maximum Plasma Concentration (Cmax) for ALN-HSD and Potential Metabolites|Fraction Excreted in Urine (fe) of ALN-HSD and Potential Metabolites|Part B: Change from Baseline of Liver Hydroxysteroid 17?? Dehydrogenase 13 (HSD17B13) Messenger Ribonucleic Acid (mRNA) |
| Sponsor/Collaborators: | Alnylam Pharmaceuticals |
| Gender: | All |
| Age: | 18 Years to 65 Years ?? (Adult, Older Adult) |
| Phases: | Phase 1 |
| Enrollment: | 103 |
| Study Type: | Interventional |
| Study Designs: | Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment |
| Start Date: | October 9, 2020 |
| Completion Date: | January 4, 2023 |
| Results First Posted: | -- |
| Last Update Posted: | March 14, 2022 |
| Locations: | Clinical Trial Site, Huntington Park, California, United States|Clinical Trial Site, Newport Beach, California, United States|Clinical Trial Site, Fleming Island, Florida, United States|Clinical Trial Site, Inverness, Florida, United States|Clinical Trial Site, Maitland, Florida, United States|Clinical Trial Site, Miami, Florida, United States|Clinical Trial Site, Iowa City, Iowa, United States|Clinical Trial Site, Marrero, Louisiana, United States|Clinical Trial Site, Baltimore, Maryland, United States|Clinical Trial Site, Detroit, Michigan, United States|Clinical Trial Site, Jackson, Mississippi, United States|Clinical Trial Site, Hermitage, Tennessee, United States|Clinical Trial Site, Arlington, Texas, United States|Clinical Trial Site, San Antonio, Texas, United States|Clinical Trial Site, San Antonio, Texas, United States|Clinical Trial Site, San Antonio, Texas, United States|Clinical Trial Site, Temple, Texas, United States|Clinical Trial Site, Brussels, Belgium|Clinical Trial Site, Edegem, Belgium|Clinical Trial Site, Pleven, Bulgaria|Clinical Trial Site, Sofia, Bulgaria|Clinical Trial Site, Stara Zagora, Bulgaria|Clinical Trial Site, Bal??ova, Turkey|Clinical Trial Site, ??zmir, Turkey|Clinical Trial Site, Topkap??, Turkey|Clinical Trial Site, Edinburgh, United Kingdom|Clinical Trial Site, London, United Kingdom|Clinical Trial Site, Nottingham, United Kingdom |
| URL: | https://ClinicalTrials.gov/show/NCT04565717 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D462 | ALN-HSD | Biological drug | -- | -- | -- | Under clinical trials | Details |
| D010 | Amoxicillin | Chemical drug | DB01060 | -- | -- | Under clinical trials | Details |
| D223 | Metabolic Cofactor Supplementation | Supplement | -- | -- | -- | Under clinical trials | Details |