ALN-CIDEB for adults with fibrotic MASH (phase 2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial explores whether ALN-CIDEB can improve liver health in adults with fibrotic metabolic dysfunction-associated steatohepatitis (MASH). Participants are randomized to receive ALN-CIDEB or placebo, with liver fat, injury markers, and fibrosis monitored over time. Researchers will assess safety and how the drug affects liver biology and function to understand variability among patients. The study includes biomarker and imaging assessments along with a per-protocol liver biopsy history to confirm NAS and fibrosis stages. Enrollment requires documented MASH with NAS ≥4 and fibrosis stage F2 or F3, plus FAST score criteria.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. 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
2. Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol
3. 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

Key Exclusion Criteria:

1. Known chronic liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol
2. Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1
3. History of liver transplantation, current placement on a liver transplant list, or MELD score \>12
4. Known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion
5. Prior, current, or planned future use of a Glucagon-Like Peptide-1 (GLP-1) receptor agonist-based therapy or any medication approved for the treatment of MASH unless used at a generally stable dose and regimen since at least 3 months prior to Screening Visit 1 or the qualifying historical liver biopsy and use is continued throughout the screening period with no change to the dose or regimen anticipated during the treatment period as described in the protocol

NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply

Where it's running

• Adobe Clinical Research
  Tucson, Arizona, United States Recruiting
• The Institute for Liver Health II LLC dba Arizona Liver Health
  Tucson, Arizona, United States Recruiting
• Del Sol Research Management, LLC
  Tucson, Arizona, United States Recruiting
• California Liver Research Institute
  Pasadena, California, United States Recruiting
• Inland Empire Clinical Trials
  Rialto, California, United States Recruiting
• Universal Axon Clinical Research
  Doral, Florida, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Endohepatology-based reclassification of treatment indication in high-risk MASLD

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• Resmetirom in children and teens with MASH

  This study tests how safe resmetirom is and how it acts in the body of kids aged 6 to 17 who have MASH with liver fibrosis.

  Recruiting Phase 2 Madrigal Pharmaceuticals, Inc. · Indianapolis, Indiana · NCT07763015

• Pre-hepatectomy rehabilitation with mazdutide for obese MASLD donors

  This trial tests whether adding mazdutide to a structured lifestyle plan helps overweight MASLD donors lose liver fat faster to become eligible for donation.

  Recruiting Phase 4 West China Hospital · Hefei, Anhui and 3 other locations · NCT07718126

• Efimosfermin vs. placebo in adults with compensated cirrhosis from MASH

  This study tests whether Efimosfermin can help adults with compensated cirrhosis due to MASH compared with placebo.

  Recruiting at 35 sites Phase 3 GlaxoSmithKline · Little Rock, Arkansas and 34 other locations · NCT07704892

• Efimosfermin vs placebo in adults with compensated cirrhosis from MASH

  This study tests whether efimosfermin helps adults with compensated cirrhosis caused by MASH compared with placebo.

  Recruiting at 30 sites Phase 3 GlaxoSmithKline · Little Rock, Arkansas and 29 other locations · NCT07701993

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.