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Phase 2Recruiting

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

Sponsored by Regeneron Pharmaceuticals

About this study

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

Where this study is enrolling (6)

  • Arizona Liver Health - Tucson

    Tucson, Arizona

    I'm interested

  • Arizona Liver Health

    Chandler, Arizona

    I'm interested

  • Adobe Clinical Research

    Tucson, Arizona

    I'm interested

  • Del Sol Research Management, LLC

    Tucson, Arizona

    Call (520) 257-3881

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  • University of Pennsylvania - Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania

    I'm interested
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Who can participate

Inclusion criteria

  • ✓1. Adult male or female ≥18 years (or country's legal age of adulthood)
  • ✓2. A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN
  • ✓3. NAS score ≥3, as defined in the protocol
  • ✓4. Meets genotype criteria for study enrollment, as defined in the protocol
  • ✓5. Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening

Exclusion criteria

  • ✕1. Evidence of other forms of known chronic liver disease, as defined in the protocol
  • ✕2. Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol
  • ✕3. History of Type 1 diabetes
  • ✕4. Bariatric surgery within approximately 5 years prior to or planned during the study period
  • ✕5. Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)
  • ✕Note: Other protocol-defined Inclusion/Exclusion Criteria apply

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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.