Evaluation of ALN-CIDEB for Safety and Effects in Adults with Fatty Liver Diseases MASLD and MASH

What this Trial Is About

Researchers are studying an experimental drug called ALN-CIDEB for adults with metabolic dysfunction-associated steatotic liver disease MASLD and metabolic dysfunction-associated steatohepatitis MASH, which are long-lasting liver conditions caused by excess fat in the liver. The main goal is to evaluate how safe and tolerable the study drug is, while also investigating side effects, how the drug changes liver fat, and its presence in the blood over time. Participants will receive either ALN-CIDEB or a placebo, given according to the study protocol. The study includes two parts Part A for MASLD patients aged 18 to 55, and Part B for MASH patients aged 18 to 65. Dosage and administration follow the protocol, with random assignment to groups. The treatment and monitoring last up to 48 weeks, with assessments covering liver fat, liver enzyme levels, drug concentrations in blood and urine, and liver cell markers. Participants will undergo regular evaluations including magnetic resonance imaging to measure liver fat, blood and urine tests to track drug levels and liver function, and clinical assessments of side effects. The study measures treatment-emergent adverse events and changes in liver health indicators over 48 weeks. This research is sponsored by Regeneron Pharmaceuticals and aims to better understand the drugs effects and safety in adults with fatty liver diseases.

A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)