Tirzepatide Superior to Placebo in MASH Resolution, Fibrosis Improvement: Daily Dose

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This week, we reported on data from the phase 2 SYNERGY-NASH study presented at the European Association for the Study of the Liver Congress 2024, held June 5-8, in Milan, Italy, and simultaneously published in NEJM.

The study

Researchers conducted the multicenter, double-blind, placebo-controlled, randomized study to examine the efficacy and safety of tirzepatide at various doses in adults who had biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. Participants were randomly assigned to receive tirzepatide 5 mg, 10 mg, or 10 mg, via subcutaneous administration once a week for 52 weeks.

The findings

Among the 190 participants, the efficacy estimand showed that 51.8%, 62.8%, and 73.3% of those who received 5 mg, 10 mg, and 15 mg doses of tirzepatide, respectively, achieved MASH resolution without worsening of fibrosis compared to 13.2% of those who received placebo at 52 weeks, meeting the study’s primary endpoint.

Researchers also reported that 59.1%, 53.3%, and 54.2% of participants who received 5 mg, 10 mg, or 15 mg of tirzepatide, respectively, had a 1-stage or greater improvement in fibrosis without worsening of MASH compared to 32.8% of those who received placebo, satisfying the study’s secondary endpoint.

Tirzepatide was also associated with improvements in body weight, blood markers of liver injury, and biomarkers of liver fat, inflammation, and fibrosis.

Authors' comment

"The study is significant, given the urgent need for treatment options that are capable of slowing the progression of the disease and potentially reducing serious health complications."

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