Phase 2: testing ALN-CIDEB for Metabolic Dysfunction-Associated Steatohepatitis
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH. In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver injury, and liver scarring.
Official registry: https://clinicaltrials.gov/study/NCT07631637 · Regeneron Pharmaceuticals · enrollment listed as 360
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-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 MASH.
They plan to enroll about 360 people at 24 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Interventions: ALN-CIDEB, Placebo
Primary outcome (registry wording): Percent Change from Baseline in Liver Fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)
Who it is for (from inclusion criteria)
- Ages 18 Years to 75 Years
- A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers and clinical risk factors, including having a history of 1 or more elements of metabolic syndrome as described in the protocol
- Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol
- Has a FibroScan Aspartate aminotransferase (FAST) score \>0.35 either at Screening Visit 1 or within approximately 3 months of Screening Visit 1 as described in the protocol
Who the registry excludes
- Known chronic liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol
- Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1
- History of liver transplantation, current placement on a liver transplant list, or MELD score \>12
- Known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion
- 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
24 listed- Adobe Clinical Research — 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)
- California Liver Research Institute — Pasadena, California (recruiting)
- Inland Empire Clinical Trials — Rialto, California (recruiting)
- Universal Axon Clinical Research — Doral, Florida (recruiting)
- Southwest General Healthcare Center — Fort Myers, Florida (recruiting)
- Genoma Research Group, Inc. — Miami, Florida (recruiting)
- Med Research of Florida, LLC — Miami, Florida (recruiting)
- Indiana University School of Medicine — Indianapolis, Indiana (recruiting)
- Kansas Medical Clinic — Topeka, Kansas (recruiting)
- Tandem Clinical Research — Marrero, Louisiana (recruiting)
+ 2 sites outside the US on the same record
FAQ about this NCT record
Is NCT07631637 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 NCT07631637?
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 NCT07631637?
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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