Testing ALN-CIDEB for fatty liver disease with liver scarring in adults
Tests the study drug ALN-CIDEB against placebo in adults with liver scarring from MASH.
Key facts
- Who runs it
- Regeneron Pharmaceuticals
- Where
- San Juan, Puerto RicoSee the siteAlso in 4 other countries, 40 sites
- Trial code
- Registry title
- Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 360 people, planned
- Started
- 6 Jul 2026
- Expected to end
- 29 Jan 2029
- Type of study
- Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ALN-CIDEB
- Placebo
- Record updated
- 9 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with fibrotic MASH, a fatty liver disease with liver scarring. It tests the study drug ALN-CIDEB against placebo.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- MASH with fibrosis stage F2 or F3 and a NAFLD Activity Score of 4 or more on a liver biopsy taken at screening. FibroScan FAST score above 0.35.
- Earlier treatment
- Use of a GLP-1 receptor agonist therapy or any medicine approved for MASH is allowed only if the dose has been generally stable since at least 3 months before screening.
- Biomarker or test result
- FibroScan Aspartate aminotransferase (FAST) score above 0.35.
Main reasons for not taking part
- Known chronic liver disease other than MASLD
- Drug-induced liver injury within about 1 year before screening
- History of liver transplant, being on a liver transplant list, or MELD score above 12
- Alcohol or other substance abuse within the last year
- Changing dose or regimen of GLP-1 receptor agonist therapy or MASH medicine
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1
- 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 use is continued 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
- Known chronic liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Puerto Rico
Also in 4 other countries, 40 sites
- Fundacion de Investigacion (FDI) Clinical ResearchSan Juan, Puerto RicoContact: Clinical Trials AdministratorTaking people
About the trial
What the trial wants to find out
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH.
Read full original descriptionShow less
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
The 3 groups in the trial
- ALN-CIDEB Dose 1Treatment being tested
Treatment: ALN-CIDEB
- ALN-CIDEB Dose 2Treatment being tested
Treatment: ALN-CIDEB
- PlaceboPlacebo, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Plain-language title
- Testing ALN-CIDEB for fatty liver disease with liver scarring in adultsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07631637, who can take part
- Record updated
- 9 November 2026