Ireland
--:--IST
Recruiting Phase 2

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

NCT07631637 · tracked via the Priya Life Science UK tracker
Phase
Phase 2
Started
2026-07-06
Last updated
2026-10-26

Condition(s) studied

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Investigational drug(s) / intervention(s)

ALN-CIDEB →Placebo

ALN-CIDEB: Administered per the protocol

Placebo: Administered per the protocol

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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. Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol 3. 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: 1. Known chronic liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol 2. Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1 3. History of liver transplantation, current placement on a liver transplant list, or MELD score \>12 4. 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 5. 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

Primary outcome measure(s)

  • Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF) — At week 26

Trial sites (16)

FacilityCityRegionStatus
Adobe Clinical Research Tucson Arizona Recruiting
The Institute for Liver Health II LLC dba Arizona Liver Health Tucson Arizona Recruiting
Del Sol Research Management, LLC Tucson Arizona Recruiting
California Liver Research Institute Pasadena California Recruiting
Inland Empire Clinical Trials Rialto California Recruiting
Universal Axon Clinical Research Doral Florida Recruiting
Genoma Research Group, Inc. Miami Florida Recruiting
Med Research of Florida, LLC Miami Florida Recruiting
Tandem Clinical Research Marrero Louisiana Recruiting
Tandem Clinical Research Metairie Louisiana Recruiting
American Research Corporation Austin Texas Recruiting
Advanced Medical Trials Georgetown Texas Recruiting
Pioneer Research Solutions, Inc. Houston Texas Recruiting
American Research Corporation at The Texas Liver Institute San Antonio Texas Recruiting
Siena Research Network Sugar Land Texas Recruiting
Fundacion de Investigacion (FDI) Clinical Research San Juan Puerto Rico Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07631637 on ClinicalTrials.gov ↗ ← All trials in the UK