Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepati… (NCT07631637) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
150 participantsStarted 2026-07-15
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent change from baseline in liver fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)
. 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