RecruitingPhase 3interventionalRules rewrite

Phase 3: testing ALN-CIDEB for Metabolic Dysfunction-Associated Steatotic Liver Disease

This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD.

Official registry: https://clinicaltrials.gov/study/NCT07854782 · Regeneron Pharmaceuticals · enrollment listed as 1,500

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

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-CIDEB, or Placebo. The registry lists allocation as randomized. This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH).

They plan to enroll about 1,500 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Interventions: ALN-CIDEB, Placebo

Primary outcome (registry wording): Occurrence of Treatment Emergent Adverse Events (TEAEs)

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
Has a clinical diagnosis of MASLD, as defined in the protocol
Has a liver stiffness measurement between 6 and 20 kilopascals (kPa), as measured by a FibroScan® scan during screening or within approximately 3 months of screening, as defined in the protocol

Who the registry excludes

Has a known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol
Has prior or current suspected or known drug-induced liver injury within approximately 1 year prior to screening
Has a history of liver transplantation, current placement on a liver transplant list, or Model for End-Stage Liver Disease (MELD) score \>12
Has a known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion
Has evidence of uncontrolled human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection during screening, as defined in the protocol
NOTE: Other Protocol-defined Inclusion/

Public study contact (from the registry)

Clinical Trials Administrator

844-734-6643

clinicaltrials@regeneron.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

Med Research of Florida, LLC — Miami, Florida (recruiting)
Tandem Clinical Research — Marrero, Louisiana (recruiting)
Tandem Clinical Research — Metairie, Louisiana (recruiting)
Advanced Medical Trials — Georgetown, Texas (recruiting)

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FAQ about this NCT record

Is NCT07854782 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 NCT07854782?

Phase 3. 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 NCT07854782?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary