NCT07631637Not yet recruitingPhase 2
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 150
- Primary Endpoint
- Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
ALN-CIDEB Dose 1
Experimental
Intervention: ALN-CIDEB (Drug)
ALN-CIDEB Dose 2
Experimental
Intervention: ALN-CIDEB (Drug)
Outcomes
Primary Outcomes
Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)
Time Frame: At week 26
Secondary Outcomes
- Change from baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)(Through week 52)
- Change from baseline in Aspartate Aminotransferase (AST)(Up to week 64)
- Change from baseline in Enhanced Liver Fibrosis (ELF)(Through week 52)
- Change from baseline in PRO-C3(Through week 52)
- Change from baseline in ADAPT(Through week 52)
- Change from baseline in NIS2+(Through week 52)
- Percent change from baseline in liver fat by MRI-PDFF in genetic subpopulations(At week 52)
- 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 for each dose level of ALN-CIDEB(Up to week 52)
- Improvement of NASH-CRN Fibrosis Stage (F) by ≥1 with no worsening of MASH(At week 52)
- Percent change from baseline in liver fat by MRI-PDFF(At week 52)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to week 64)
- Severity of TEAEs(Up to week 64)
- Achievement of a ≥30% reduction in liver fat by MRI-PDFF(At week 52)
- Change from baseline in FibroScan Controlled Attenuation Parameter (CAP)(Through week 52)
- Achievement of ≤5% liver fat by MRI-PDFF(At week 52)
- Change from baseline in Alanine Aminotransferase (ALT)(Up to week 64)
Investigators
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