A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Metabolic Dysfunction-Associated SteatoHepatitis (MASH)
In brief
This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH). MASH is a form of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring related to MASH. The study is looking at several other research questions, including: * How ALN-HSD works to improve liver function and lessen MASH-related inflammation in the liver * What side effects may happen from receiving the study drug * How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times * Better understanding of the study drug and MASH
Key facts
- Study ID
- NCT05519475
- Run by
- Regeneron Pharmaceuticals
- People needed
- 120
- Starts
- 2023-02-09
- Expected to finish
- 2028-12-07
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Indiana University School of Medicine — Indianapolis, Indiana, United States (enrolling)
- Columbia University Irving Medical Center — New York, New York, United States (enrolling)
- Health Awareness, inc. — Jupiter, Florida, United States (enrolling)
- Charter Research LLC - Orlando — Orlando, Florida, United States (enrolling)
- GI Associates — Flowood, Mississippi, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- Adobe Clinical Research — Tucson, Arizona, United States (enrolling)
- Arizona Liver Health — Chandler, Arizona, United States (enrolling)
- Genoma Research Group, Inc. — Miami, Florida, United States (enrolling)
- Med Research of Florida, LLC — Miami, Florida, United States (enrolling)
- Tandem Clinical Research — Metairie, Louisiana, United States (enrolling)
- Om Research Llc — Lancaster, California, United States (enrolling)
- Ark Clinical Research - Long Beach — Long Beach, California, United States (enrolling)
- The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria — Peoria, Arizona, United States (enrolling)
- Clinnova Research Solutions — Orange, California, United States (enrolling)
- Knowledge Research Center, St. Joseph's Medical Tower — Orange, California, United States (enrolling)
- Southern California Research Center — Coronado, California, United States (enrolling)
- California Liver Research Institute — Pasadena, California, United States (enrolling)
- Ark Clinical Research - Fountain Valley — Fountain Valley, California, United States (enrolling)
- Inland Empire Liver Foundation — Rialto, California, United States (enrolling)
- Arizona Liver Health - Tucson — Tucson, Arizona, United States (enrolling)
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
- Del Sol Research Management, LLC — Tucson, Arizona, United States (enrolling)
- Evolution Clinical Trials — Hialeah Gardens, Florida, United States (enrolling)
- Geisinger Medical Center — Danville, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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