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

NCT07631637 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ALN-CIDEB-MASH-26032026-525916-33-00
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)

  At week 26

Secondary Outcomes (17)

• Resolution of MASH with no worsening of Nonalcoholic Steatohepatitis-Clinical Research Network (NASH-CRN) fibrosis on liver biopsy

  At week 52

• Percent change from baseline in liver fat by MRI-PDFF

  At week 52

• Achievement of a ≥30% reduction in liver fat by MRI-PDFF

  At week 52

• Achievement of ≤5% liver fat by MRI-PDFF

  At week 52

• Percent change from baseline in liver fat by MRI-PDFF for each dose level of ALN-CIDEB

  Up to week 52

Study Arms (3)

ALN-CIDEB Dose 1

EXPERIMENTAL

Drug: ALN-CIDEB

ALN-CIDEB Dose 2

EXPERIMENTAL

Drug: ALN-CIDEB

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALN-CIDEB DRUG

Administered per the protocol

ALN-CIDEB Dose 1; ALN-CIDEB Dose 2

Placebo DRUG

Administered per the protocol

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Hepatitis; Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): February 6, 2029
• Study Completion (Estimated): February 6, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf