Recruiting
Phase 2

ALN-CIDEB

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07631637

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ALN-CIDEB

Placebo

Study Details

Brief summary:

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

Conditions

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Study ID

NCT07631637

Start date

Jul 6, 2026

Status verified date

Oct, 2026

Completion date

Jan 29, 2029

Anticipated

Primary completion date

Jan 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 and/or a score on the AUDIT questionnaire ≥8
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 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALN-CIDEB Dose 1

experimental: ALN-CIDEB Dose 2

placebo comparator: Placebo

Interventions

ALN-CIDEB

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) [ Time Frame: At week 26 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Adobe Clinical Research

Recruiting

Tucson, Arizona, United States, 85712

The Institute for Liver Health II LLC dba Arizona Liver Health

Recruiting

Tucson, Arizona, United States, 85712

Del Sol Research Management, LLC

Recruiting

Tucson, Arizona, United States, 85715

California Liver Research Institute

Recruiting

Pasadena, California, United States, 91105

Inland Empire Clinical Trials

Recruiting

Rialto, California, United States, 92377

Universal Axon Clinical Research

Recruiting

Doral, Florida, United States, 33166

Genoma Research Group, Inc.

Recruiting

Miami, Florida, United States, 33173

Med Research of Florida, LLC

Recruiting

Miami, Florida, United States, 33186

Tandem Clinical Research

Recruiting

Marrero, Louisiana, United States, 70072

Tandem Clinical Research

Recruiting

Metairie, Louisiana, United States, 70006

American Research Corporation

Recruiting

Austin, Texas, United States, 78757

Advanced Medical Trials

Recruiting

Georgetown, Texas, United States, 78628

Pioneer Research Solutions, Inc.

Recruiting

Houston, Texas, United States, 77099

American Research Corporation at The Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Siena Research Network

Recruiting

Sugar Land, Texas, United States, 77479

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • F2 or F3 MASH
  • Fibrotic MASH
  • Nonalcoholic Fatty Liver Disease (NAFLD)
  • Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)
  • Liver Inflammation
  • Liver Fibrosis
  • Cirrhosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.