Meeting Coverage > > EASL– GLP-1/ GIP agonist likewise enhanced fibrosis biomarkers, liver fat, and tightness in stage II trial
by Katherine Kahn, Staff Writer, MedPage Today June 8, 2024
Last Updated June 11, 2024
The weight-loss and diabetes drug tirzepatide solved metabolic dysfunction-associated steatohepatitis (MASH) and liver fibrosis, according to the outcomes of the SYNERGY-NASH stage II research study.
Amongst 190 individuals with biopsy-confirmed MASH and fibrosis, the treatment program estimand revealed resolution of MASH without intensifying of fibrosis in 44% of clients in the once-weekly 5-mg tirzepatide group, 50% in the 10-mg group, and 62% in the 15-mg group compared to 10% in the placebo group (P< 0.001 for all), reported Rohit Loomba, MD, of the University of California San Diego, at the European Association for the Study of the Liver yearly conference.
Outcomes of the trial were at the same time released in the New England Journal of Medicine
“MASH is the 2nd most typical factor to liver hair transplant in the U.S., highlighting the requirement for unique treatments,” Loomba commented in a news release from tirzepatide producer Eli Lilly. “The research study is substantial, provided the immediate requirement for treatment choices that can slowing the development of the illness and possibly decreasing severe health issues.”
The mix glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist got FDA approval for type 2 diabetes (Mounjaro) in 2022, followed by FDA approval for the management of weight problems or obese (Zepbound) in 2023.
Loomba likewise provided an effectiveness analysis that consisted of all randomized individuals other than for information gotten after irreversible discontinuation of tirzepatide or placebo. Because analysis, the effectiveness estimand revealed that 51.8% of clients in the 5-mg tirzepatide group, 62.8% in the 10-mg group, and 73.3% in the 15-mg group had resolution of MASH without any worsening of fibrosis, compared to 13.2% in the placebo group.
In an essential secondary endpoint, the portion of individuals who had a decline of a minimum of one fibrosis phase without intensifying of MASH was 55%, 51%, and 51% of individuals taking 5 mg-, 10 mg- and 15 mg tirzepatide, respectively, versus 30% in the placebo group (P< 0.05).
When asked throughout a Q&A session about the 30% action rate in the placebo group, Loomba hypothesized that “it’s truly a tyranny of little numbers.” The placebo group had an overall of 48 clients whereas the overall variety of individuals in the treatment groups was around 3 times that. “That’s why I believe the accuracy price quotes are unclear,” he discussed.
Laurent Castera, MD, PhD, of the University of Paris Cité in Clichy, France, wondered to understand why there seemed “no dosage result on fibrosis” with tirzepatide in the trial. Loomba responded that, once again, this is likely a result of the little stage II trial style. “Typically, if we had 300 clients per arm,
