Efimosfermin Alfa for NASH

(ZENITH-1 Trial)

This trial tests a new treatment called efimosfermin alfa to determine its effectiveness for people with MASH, a liver condition characterized by fat accumulation and inflammation, leading to liver scarring. The goal is to assess whether this treatment can safely improve liver health more effectively than a placebo (a non-active substance). Participants will be assigned to groups receiving different doses of the treatment or a placebo. Ideal candidates have been diagnosed with MASH, have liver scarring confirmed by a biopsy, and exhibit two or more signs of metabolic syndrome, such as high blood pressure or elevated blood sugar. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research has shown that efimosfermin alfa is generally safe. In earlier studies involving individuals with MASH, a type of liver disease, this treatment improved liver health. Importantly, these studies found that efimosfermin alfa was well-tolerated, causing few serious side effects. While some treatments can have negative effects, current data suggests that efimosfermin alfa is generally safe for people.¹²³⁴⁵

Most treatments for NASH (nonalcoholic steatohepatitis) focus on lifestyle changes and managing symptoms through medications like vitamin E and pioglitazone. However, efimosfermin alfa is unique because it targets the underlying metabolic pathways involved in NASH. This treatment works by modulating insulin sensitivity and reducing liver fat, which could directly address the root causes of the disease. Researchers are excited about efimosfermin alfa because it offers a novel approach that could potentially improve liver health and patient outcomes more effectively than current options.

Studies have shown that efimosfermin alfa can improve liver health in people with NASH, a type of liver disease. Research indicates it reduces liver fat and signs of liver damage, which signal a healthier liver. Previous participants experienced improvements in liver scarring. These results suggest that efimosfermin alfa could heal liver inflammation and damage. Overall, earlier studies have shown it to be safe. Participants in this trial will receive either dose level 1 or dose level 2 of efimosfermin alfa, or a placebo, to further evaluate its effectiveness and safety.¹²³⁴⁶