Phase 3Not yet recruiting
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)
- Sponsor
- Regeneron Pharmaceuticals (Industry)
- Enrolment
- 1,500 planned
- Conditions
- Metabolic Dysfunction-Associated Steatotic Liver Disease; MASLD
- Interventions
- ALN-CIDEB; Placebo
- Ages
- adults, older adults
- Registry
- NCT07854782
From the registry
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
Primary outcomes
- Occurrence of Treatment Emergent Adverse Events (TEAEs)
- Severity of TEAEs