Phase 2: testing ALN-HSD for Metabolic Dysfunction-Associated SteatoHepatitis (MASH)
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).
Official registry: https://clinicaltrials.gov/study/NCT05519475 · Regeneron Pharmaceuticals · enrollment listed as 120
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are ALN-HSD, or Placebo. The registry lists allocation as randomized. This study is researching an investigational drug, ALN-HSD called "study drug".
They plan to enroll about 120 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of siRNA Gene Silencing for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Participants With Genetic Risk Factors
Interventions: ALN-HSD, Placebo
Primary outcome (registry wording): Change in quantitative liver Fibrosis (qFibrosis)
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- Adult male or female ≥18 years (or country's legal age of adulthood)
- A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN
- NAS score ≥3, as defined in the protocol
- Meets genotype criteria for study enrollment, as defined in the protocol
- Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening
Who the registry excludes
- Evidence of other forms of known chronic liver disease, as defined in the protocol
- Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol
- History of Type 1 diabetes
- Bariatric surgery within approximately 5 years prior to or planned during the study period
- 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/
Public study contact (from the registry)
Clinical Trials Administrator
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
71 listed- The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff — Flagstaff, Arizona (terminated)
- The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria — Peoria, Arizona (recruiting)
- Adobe Clinical Research — Tucson, Arizona (recruiting)
- Arizona Liver Health - Tucson — Tucson, Arizona (recruiting)
- The Institute for Liver Health II LLC dba Arizona Liver Health — Tucson, Arizona (recruiting)
- Del Sol Research Management, LLC — Tucson, Arizona (recruiting)
- San Fernando Valley Health Institute — Canoga Park, California (terminated)
- Velocity Clinical Research — Chula Vista, California (terminated)
- Southern California Research Center — Coronado, California (recruiting)
- Velocity Clinical Research — Gardena, California (terminated)
- Velocity Clinical Research - Huntington Park — Huntington Park, California (terminated)
- Om Research Llc — Lancaster, California (recruiting)
+ 10 sites outside the US on the same record
FAQ about this NCT record
Is NCT05519475 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05519475?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05519475?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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