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Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

RecruitingPhase 2

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

Sponsor: Regeneron Pharmaceuticals · Participants: 360 · Started: Jul 6, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07631637

Locations in the U.S.

ArizonaAdobe Clinical Research, Tucson
Del Sol Research Management, LLC, Tucson
The Institute for Liver Health II LLC dba Arizona Liver Health, Tucson
CaliforniaCalifornia Liver Research Institute, Pasadena
Inland Empire Clinical Trials, Rialto
FloridaUniversal Axon Clinical Research, Doral
Southwest General Healthcare Center, Fort Myers
Genoma Research Group, Inc., Miami
Med Research of Florida, LLC, Miami
IndianaIndiana University School of Medicine, Indianapolis
KansasKansas Medical Clinic, Topeka
LouisianaTandem Clinical Research, Marrero
Tandem Clinical Research, Metairie
PennsylvaniaGeisinger Medical Center, Danville
TennesseeQuality Medical Research - Nashville, Nashville
TexasTexas Clinical Research Institute, LLC, Arlington
American Research Corporation, Austin
Methodist Dallas Medical Center, Dallas
Advanced Medical Trials, Georgetown
Pioneer Research Solutions, Inc., Houston
American Research Corporation at The Texas Liver Institute, San Antonio
Siena Research Network, Sugar Land

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.