Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Regeneron Pharmaceuticals · NCT07631637
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–75 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 150
- US sites recruiting
- 15
- Study start
- July 6, 2026
- Record last updated
- October 26, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: ALN-CIDEB; Placebo
Conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key 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
Key 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
Recruiting US locations
Adobe Clinical Research
Tucson, AZ 85712
The Institute for Liver Health II LLC dba Arizona Liver Health
Tucson, AZ 85712
Del Sol Research Management, LLC
Tucson, AZ 85715
California Liver Research Institute
Pasadena, CA 91105
Inland Empire Clinical Trials
Rialto, CA 92377
Universal Axon Clinical Research
Doral, FL 33166
Genoma Research Group, Inc.
Miami, FL 33173
Med Research of Florida, LLC
Miami, FL 33186
Tandem Clinical Research
Marrero, LA 70072
Tandem Clinical Research
Metairie, LA 70006
American Research Corporation
Austin, TX 78757
Advanced Medical Trials
Georgetown, TX 78628
Pioneer Research Solutions, Inc.
Houston, TX 77099
American Research Corporation at The Texas Liver Institute
San Antonio, TX 78215
Siena Research Network
Sugar Land, TX 77479
Study contacts (from the official record)
- Clinical Trials Administrator · 844-734-6643 · clinicaltrials@regeneron.com
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