Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALN-CIDEB, Placebo.
- Who it may be relevant to
- Registry conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Overview
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. The study will compare ALN-CIDEB with placebo to understand how well ALN-CIDEB works to lower the amount of fat in the liver. The study is looking at: * What side effects ALN-CIDEB might cause * How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring * How the body and the liver change after having ALN-CIDEB, which can help researchers understand why ALN-CIDEB works better for some people than others
Interventions
- Drug ALN-CIDEB
Administered per the protocol - Drug Placebo
Administered per the protocol
Primary outcome measures
- Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) [Time frame: At week 26]
Secondary outcome measures (12)
- Resolution of MASH with no worsening of Nonalcoholic Steatohepatitis-Clinical Research Network (NASH-CRN) fibrosis on liver biopsy [Time frame: At week 52]
- Percent change from baseline in liver fat by MRI-PDFF [Time frame: At week 52]
- Achievement of a ≥30% reduction in liver fat by MRI-PDFF [Time frame: At week 52]
- Achievement of ≤5% liver fat by MRI-PDFF [Time frame: At week 52]
- Percent change from baseline in liver fat by MRI-PDFF for each dose level of ALN-CIDEB [Time frame: Up to week 52]
- Improvement of NASH-CRN Fibrosis Stage (F) by ≥1 with no worsening of MASH [Time frame: At week 52]
- Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to week 64]
- Severity of TEAEs [Time frame: Up to week 64]
- Change from baseline in FibroScan Controlled Attenuation Parameter (CAP) [Time frame: Through week 52]
- Change from baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) [Time frame: Through week 52]
- Change from baseline in Aspartate Aminotransferase (AST) [Time frame: Up to week 64]
- Change from baseline in Alanine Aminotransferase (ALT) [Time frame: Up to week 64]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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 and/or a score on the AUDIT questionnaire ≥8
- 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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07631637 · ALN-CIDEB-MASH-2603 · 2026-525916-33-00