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

ConditionMetabolic Dysfunction-Associated Steatohepatitis (MASH)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRegeneron Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ALN-CIDEB

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: ALN-CIDEB Dose 1Experimental treatment 1 intervention
Group B: ALN-CIDEB Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Time frame
At week 52
2

Percent change from baseline in liver fat by MRI-PDFF

Time frame
At week 52
3

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

Time frame
At week 52
4

Achievement of ≤5% liver fat by MRI-PDFF

Time frame
At week 52

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: