Tirzepatide, a weight loss and diabetes drug, has shown promising results in treating Metabolic Dysfunction Associated Steatohepatitis (MASH) in a phase II study called SYNERGY-NASH. The study, presented by Dr. Rohit Loomba at the European Association for the Study of the Liver annual meeting, demonstrated significant resolution of MASH and liver fibrosis in participants receiving tirzepatide compared to a placebo group.
The SYNERGY-NASH study included 190 participants with biopsy-confirmed MASH and fibrosis, who were divided into different dosing groups of tirzepatide. The results showed that 44% of patients in the 5-mg group, 50% in the 10-mg group, and 62% in the 15-mg group had resolution of MASH without worsening of fibrosis, compared to only 10% in the placebo group. These findings highlight the potential of tirzepatide in treating a condition that is a significant contributor to liver transplantation in the U.S.
In an efficacy analysis that included all randomized participants except for data after the discontinuation of tirzepatide or placebo, it was found that the higher dosages of tirzepatide led to better outcomes in resolving MASH with no worsening of fibrosis. The study also revealed a significant decrease in fibrosis stage in participants taking tirzepatide compared to the placebo group, indicating the drug’s potential in slowing disease progression.
Apart from histological improvements, the study also observed reductions in MRI-assessed liver fat content, liver stiffness, and biomarkers related to MASH and fibrosis. Serum biomarkers showed significant reductions in NIS4, ELF, and Pro-C3 in the active treatment groups, further supporting the efficacy of tirzepatide in targeting liver pathology. In terms of safety, adverse events were reported more frequently in the tirzepatide group, with gastrointestinal events being the most common. However, treatment discontinuation rates and serious adverse events were similar between the treatment and placebo groups.
Dr. Loomba and his team believe that tirzepatide has the potential to become a novel therapeutic option for patients with MASH and liver fibrosis. The results of the SYNERGY-NASH study provide valuable insights into the efficacy and safety of tirzepatide in this patient population. However, further research is needed to understand the long-term effects and optimal dosing of tirzepatide in treating MASH and associated liver conditions.
The SYNERGY-NASH phase II study demonstrates that tirzepatide shows promise in resolving MASH and liver fibrosis, offering new hope for patients with these conditions. The findings of this study pave the way for future research and clinical trials to explore the full potential of tirzepatide in addressing the unmet medical needs of patients with metabolic liver diseases.