ALN-CIDEB in adults with MASLD to see if it helps the liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study evaluates ALN-CIDEB versus placebo in adults diagnosed with MASLD, a fatty liver condition that can lead to scarring and inflammation. The trial will assess safety and how well the drug affects liver fat, liver injury markers, and fibrosis progression. Participants will receive the study drug or placebo over a defined treatment period, with monitoring to understand who may respond best and why. Enrollment requires specific liver stiffness measurements and excludes other serious liver diseases or recent drug-induced liver injury. The study helps researchers understand the drug's effects on the liver and potential differences in response among individuals.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Has a clinical diagnosis of MASLD, as defined in the protocol
2. 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

Key Exclusion Criteria:

1. Has a known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol
2. Has prior or current suspected or known drug-induced liver injury within approximately 1 year prior to screening
3. Has a history of liver transplantation, current placement on a liver transplant list, or Model for End-Stage Liver Disease (MELD) score \>12
4. 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
5. 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
6. 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

Where it's running

• Med Research of Florida, LLC
  Miami, Florida, United States Recruiting
• Tandem Clinical Research
  Marrero, Louisiana, United States Recruiting
• Tandem Clinical Research
  Metairie, Louisiana, United States Recruiting
• Advanced Medical Trials
  Georgetown, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low‑methoxy pectin for inflammation, gut microbiome, and metabolic health in MASLD

  This tests whether taking daily low‑methoxy pectin for six weeks can reduce inflammation and improve gut bacteria and metabolic markers in adults with MASLD.

  Recruiting at 3 sites University of Nottingham · Nottingham, United Kingdom and 2 other locations · NCT07093346

• Endoscopic sleeve gastroplasty for people with obesity and MASH

  This study will test whether endoscopic sleeve gastroplasty plus lifestyle changes helps adults with obesity and MASH lose weight and improve liver health compared with lifestyle changes alone.

  Recruiting at 2 sites Brigham and Women's Hospital · Boston, Massachusetts and 1 other locations · NCT06138821

• Health profile of MASLD in Kazakhstan and real-world use of Ursosan in Almaty

  This study tests how MASLD appears in adults in Kazakhstan and how Ursosan is used in real-world care for a subgroup in Almaty.

  Recruiting at 7 sites Kazakh Association of Internal Medicine Specialists · Aktobe, Aktobe and 6 other locations · NCT07889999

• Endohepatology-based reclassification of treatment indication in high-risk MASLD

  This study tests whether an endohepatology assessment can change treatment decisions for adults with high-risk MASLD.

  Recruiting University Hospital Muenster · Münster · NCT07877272

• Reset-INSPIRE: See if CGM can reveal insulin sensitivity in people at risk for MASLD

  This study tests whether real-time CGM data can accurately reflect insulin sensitivity in adults without diabetes who are at risk for MASLD.

  Recruiting National University Health System, Singapore · Singapore, Singapore · NCT07861191

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.