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ALN-CIDEB

Phase 2

Metabolic Dysfunction-Associated Steatohepatitis (MASH) | Small molecule | Metabolic |Regeneron Pharmaceuticals, Inc.|Last Updated: Jul 8, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

ALN-CIDEB · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT07631637Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)Metabolic Dysfunction-Associated Steatohepatitis (MASH)
NOT YET_RECRUITING150 Analytics
PHASE2NOT YET_RECRUITING
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)Unlock trial analytics

Study Endpoints

Primary Endpoints

Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)
At week 26
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Up to 48 Weeks
Severity of TEAEs
Up to 48 Weeks

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALN-CIDEB Dose 1EXPERIMENTAL -
ALN-CIDEB Dose 2EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Part AEXPERIMENTALRandomized per the protocol
Part BEXPERIMENTALRandomized per the protocol

Interventions

NameTypeDescription
ALN-CIDEBDRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

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. Screenin...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 8, 2026NCT06836609lastUpdatePostDate: changed
LOWJul 8, 2026NCT06836609lastUpdatePostDate: changed
LOWJun 8, 2026NCT07631637NEW_TRIAL: changed
LOWJun 8, 2026NCT07631637NEW_TRIAL: changed
LOWJun 8, 2026NCT07631637NEW_TRIAL: changed

Frequently asked questions about ALN-CIDEB

What is ALN-CIDEB used for?

ALN-CIDEB is an investigational drug being developed for Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). It is being studied in adult participants with these liver conditions, including those with fibrotic MASH.

Who makes ALN-CIDEB?

ALN-CIDEB is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metabolic liver diseases.

What phase is ALN-CIDEB in?

ALN-CIDEB is currently in Phase 2 clinical development. It is being evaluated in a Phase 2 study for fibrotic MASH, and it is also being studied in an earlier-phase trial for MASLD and MASH. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials is ALN-CIDEB in?

ALN-CIDEB is being studied in two clinical trials. NCT06836609 is a Phase 1 study in adults with MASLD or MASH, enrolling 132 participants in the United States and United Kingdom. NCT07631637 is a Phase 2 study in adults with fibrotic MASH, enrolling 150 participants.

Is ALN-CIDEB the same as another drug?

ALN-CIDEB is the primary name used for this investigational drug in clinical trials. No alternative names have been reported for this compound. It is being developed specifically for metabolic liver diseases and is not known to be marketed under any other brand name.