Significant Results in MASH Treatment
Eli Lilly recently announced the results of their phase 2 SYNERGY-NASH study, which investigated the use of tirzepatide in treating metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. This condition, previously known as nonalcoholic steatohepatitis (NASH), is a serious liver disease that often progresses to cirrhosis and liver failure.
Key Outcomes
1. MASH Resolution Without Worsening of Fibrosis
- Placebo: Only 13.2% of participants showed MASH resolution without fibrosis worsening.
- 5 mg Tirzepatide: 51.8% achieved this outcome.
- 10 mg Tirzepatide: 62.8% achieved this outcome.
- 15 mg Tirzepatide: 73.3% achieved this outcome.
These results demonstrate a clear dose-response relationship, with higher doses of tirzepatide leading to better outcomes.
2. Fibrosis Improvement Without Worsening of MASH
- Placebo: 32.8% saw a 1-stage or greater improvement in fibrosis.
- 5 mg Tirzepatide: 59.1% saw improvement.
- 10 mg Tirzepatide: 53.3% saw improvement.
- 15 mg Tirzepatide: 54.2% saw improvement.
3. Additional Benefits
- Participants taking tirzepatide also experienced significant improvements in body weight, blood markers of liver injury, and biomarkers of liver fat, inflammation, and fibrosis.
Expert Commentary
Dr. Rohit Loomba from the University of California San Diego School of Medicine emphasized the importance of these findings, noting the urgent need for treatments capable of slowing MASH progression and reducing severe health complications.
Safety Profile
The safety profile of tirzepatide in this study was consistent with previous trials (SURMOUNT and SURPASS), with the most common side effects being gastrointestinal-related and generally mild to moderate in severity.
Future Steps
Eli Lilly is in discussions with regulatory authorities to determine the next steps for tirzepatide as a treatment for MASH. Given the significant impact MASH has on millions of adults, the potential of tirzepatide to offer a clinically meaningful treatment effect is promising.
About the Study and Tirzepatide
SYNERGY-NASH Study: A multicenter, double-blind, randomized, placebo-controlled phase 2 trial with 190 participants. It evaluated the efficacy and safety of tirzepatide in adults with biopsy-confirmed MASH and stage 2 or 3 fibrosis over 52 weeks.
Tirzepatide: A once-weekly dual GIP and GLP-1 receptor agonist, approved as Mounjaro for type 2 diabetes treatment and under investigation for other conditions, including obesity, sleep apnea, and chronic kidney disease.
For further details, the full study results were presented at the European Association for the Study of the Liver (EASL) Congress 2024 and published in The New England Journal of Medicine.
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