Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07631637

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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

Treatment and study plan

ALN-CIDEB

Drug

Administered per the protocol

Placebo

Drug

Administered per the protocol

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

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

    Time frame: Up to week 52

  6. Improvement of NASH-CRN Fibrosis Stage (F) by ≥1 with no worsening of MASH

    Time frame: At week 52

  7. Occurrence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to week 64

  8. Severity of TEAEs

    Time frame: Up to week 64

  9. Change from baseline in FibroScan Controlled Attenuation Parameter (CAP)

    Time frame: Through week 52

  10. Change from baseline in FibroScan Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE)

    Time frame: Through week 52

  11. Change from baseline in Aspartate Aminotransferase (AST)

    Time frame: Up to week 64

  12. Change from baseline in Alanine Aminotransferase (ALT)

    Time frame: Up to week 64

  13. Change from baseline in Enhanced Liver Fibrosis (ELF)

    Time frame: Through week 52

  14. Change from baseline in PRO-C3

    Time frame: Through week 52

  15. Change from baseline in ADAPT

    Time frame: Through week 52

  16. Change from baseline in NIS2+

    Time frame: Through week 52

  17. Percent change from baseline in liver fat by MRI-PDFF in genetic subpopulations

    Time frame: At week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.