The safety profile of tirzepatide in SYNERGY-NASH was in line with that seen in the SURMOUNT and SURPASS trials. Credit: Emily frost / Shutterstock.

Eli Lilly has released data from the Phase II SYNERGY-NASH study of tirzepatide in adult patients with metabolic dysfunction-associated steatohepatitis (MASH) and stage 2 or 3 fibrosis.

The double-blind, multicentre, placebo-controlled trial enrolled 190 participants irrespective of their type 2 diabetes status to assess the safety and efficacy of tirzepatide at varying doses.

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Participants were administered tirzepatide or a placebo subcutaneously once a week for one year.

MASH resolution without fibrosis worsening at 52 weeks was the trial’s primary endpoint while secondary endpoints comprise fibrosis improvement without MASH worsening.

The study met its primary endpoint, with tirzepatide showing a significant effect on MASH resolution without worsening fibrosis after 52 weeks.

Results indicated that 51.8%, 62.8%, and 73.3% of participants receiving tirzepatide doses of 5mg, 10mg, and 15mg respectively, showed an absence of MASH with no fibrosis worsening versus 13.2% on placebo.

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Additionally, 59.1%, 53.3%, and 54.2% of participants across the respective tirzepatide doses achieved at least a one-stage improvement in fibrosis without MASH worsening, versus 32.8% on placebo.

The study also observed tirzepatide’s positive impact on body weight, liver injury markers, and biomarkers of liver fat, inflammation, and fibrosis.

Tirzepatide’s safety profile in SYNERGY-NASH was in line with that seen in the SURMOUNT and SURPASS trials, with gastrointestinal issues being the most commonly reported adverse events.

Currently, discussions are underway with regulatory authorities regarding the next steps for tirzepatide as a treatment for MASH.

Eli Lilly product development senior vice-president Jeff Emmick said: “Lilly is very pleased with the degree of MASH resolution observed in the SYNERGY-NASH study, and we are encouraged by the improvement of fibrosis observed.

“MASH is expected to impact more than 19 million adults in the US by 2039 and based on the study results, we believe tirzepatide may have the potential to help people living with this disease.” 

In April this year, the company reported positive data from the SURMOUNT-OSA Phase III trials, indicating that tirzepatide could potentially reduce the severity of sleep apnoea in adults with obstructive sleep apnoea and obesity.