NCT07854782RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD. MASLD is a liver condition caused by too much fat building up in the liver. This can lead to liver scarring and inflammation and can reduce the liver's ability to keep the body healthy. Cell death-inducing DFFA-like effector B (CIDEB) is a protein made by liver cells that helps the liver to store fat. 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 ALN-CIDEB could affect the body and the liver, which can help researchers understand why ALN-CIDEB works better for some people than others
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1500 (estimated)
- First submitted
- 28 Sept 2026
- Start date
- 28 Oct 2026
- Primary completion date
- 3 Mar 2029
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07854782
- EU CT number
- 2026-526723-22-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1500
- From 28 Oct 2026 to the primary completion date, 3 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has prior or current suspected or known drug-induced liver injury within approximately 1 year prior to screening
- Has prior, current, or planned future use (during the treatment period) of a GLP-1 receptor agonist-based therapy or any medication approved for the treatment of MASH (eg, resmetirom) unless used at a generally stable dose and regimen since at least 3 months prior to screening visit and throughout the screening period with no change to the dose or regimen anticipated during the treatment period, as defined in the protocol
Other illness
- Has a known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol
- Has a history of liver transplantation, current placement on a liver transplant list, or Model for End-Stage Liver Disease (MELD) score \>12
- Has a known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion
- Has evidence of uncontrolled human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection during screening, as defined in the protocol
- NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
Who the study is looking for
- Has a clinical diagnosis of MASLD, as defined in the protocol
- Has a liver stiffness measurement between 6 and 20 kilopascals (kPa), as measured by a FibroScan® scan during screening or within approximately 3 months of screening, as defined in the protocol
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Advanced Medical Trials Coordinator of this site? Confirm its status | Georgetown | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.