Meeting Coverage > > AASLD– First favorable stage III research study for a GLP-1 agonist in persistent liver illness
by Mike Bassett, Staff Writer, MedPage Today November 20, 2024
Semaglutide (Wegovy) enhanced liver fibrosis in clients with metabolic dysfunction-associated steatohepatitis (MASH) and resulted in higher rates of MASH resolution, an interim analysis of a stage III trial revealed.
In part 1 of the so-called ESSENCE trial, treatment with the GLP-1 receptor agonist led to greater week-72 rates of steatohepatitis resolution without getting worse of liver fibrosis (63% vs 34% with placebo) and enhancement in liver fibrosis without intensifying of steatohepatitis (37% vs 23%; P
Two times as lots of clients designated to semaglutide accomplished the double secondary endpoint of both MASH resolution and liver fibrosis enhancement (33% vs 16%P
Newsome's discussion at the yearly conference of the American Association for the Study of Liver Diseases in San Diego was consulted with continual applause, with one audience member calling the outcomes “the emphasize of our conference.” Another stated it was “a watershed minute for the MASH field.”
“It is terrific to be able to report the very first GLP-1 receptor agonist to show effectiveness in a stage III trial of MASH, with supremacy verified for semaglutide versus placebo for both the main endpoints,” the double secondary endpoint, and for a host of non-invasive markers of liver fibrosis, Newsome stated throughout a late-breaking abstract session. “Reassuringly, the security profile remains in keeping with a previous stage II scientific trial and likewise the bigger body of information for semaglutide.”
The main endpoint for part 2 of the trial will examine semaglutide's result on cirrhosis-free survival, however maker Novo Nordisk has actually currently revealed it will declare regulative approval in MASH next year based upon the existing outcomes.
Just one drug is presently shown for MASH, a serious type of metabolic dysfunction-associated steatotic liver illness (MASLD). The FDA gave sped up approval to resmetirom (Rezdiffra) previously this year based upon outcomes of the MAESTRO-NASH research study.
ESSENCE is a continuous, double-blind, multicenter stage III trial including 1,200 adult individuals with biopsy-defined MASH and phase 2/3 liver fibrosis. The research study randomized individuals 2:1 to once-weekly subcutaneous semaglutide at a dosage of 2.4 mg (after a 16-week dosage escalation) or matching placebo for 240 weeks.
Eligibility requirements consisted of a non-alcoholic fatty liver illness (NAFLD) activity rating ≥ 4. Clients were omitted if they had persistent liver illness besides MASLD; had actually understood or presumed extreme alcohol usage; were currently on a GLP-1 receptor agonist; or had unsteady usage of other glucose-lowering, lipid-lowering, or weight-loss medications within 90 days of screening.
Newsome reported interim security and effectiveness outcomes for the very first 800 individuals who finished 72 weeks of treatment.
