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ALN-CIDEB

Phase 1

Metabolic Dysfunction-Associated Steatotic Liver Disease | Small molecule | Infectious Disease |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment132
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06836609A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)PHASE1 RECRUITING 132Apr 28, 2025May 15, 2027Apr 27, 20263 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Up to 48 Weeks
Severity of TEAEs
Up to 48 Weeks
Secondary Endpoints
Change in liver fat fraction by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
Baseline up to 48 Weeks
Total concentration of ALN-CIDEB in plasma
Up to 48 Weeks
Total concentration of potential major metabolite(s) in plasma
Up to 48 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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 — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria: 1. Part A: 18 to 55 years at Screening Visit 1 with MASLD, at Screening Visit 1 Part B: 18 to 65 years at Screening Visit 1 with a diagnosis of MASH, at Screening Visit 1 2. Body Mass Index (BMI) ≥30 kg/m2 and ≤40 kg/m2 at Screening Visit 1 3. Controlled-Attenuation Paramete...

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06836609primaryCompletionDate: changed
LOWMay 24, 2026NCT06836609studyFirstPostDate: changed