Home › Steatotic Liver Disease › NCT07631637
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
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
About the study
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
What is being tested
- ALN-CIDEB (drug)
- Placebo (drug)
Sponsor: Regeneron Pharmaceuticals · Participants: 360 · Started: Jul 6, 2026
Contact the study team
- Clinical Trials Administrator · Phone: 844-734-6643
Official record on ClinicalTrials.gov — NCT07631637
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.