Altimmune, Inc. announced the data from its 12-week clinical trial of pemvidutide, an investigational GLP-1/glucagon dual receptor agonist, in metabolic dysfunction-associated steatotic liver disease (MASLD) has been published in the Journal of Hepatology. In the study, 94 subjects with obesity or overweight and LFC =10% were randomized and dosed 1:1:1:1 to pemvidutide (1.2mg, 1.8mg and 2.4mg) or placebo administered once-weekly subcutaneously for 12 weeks. The study did not include diet or exercise interventions.

Relative reductions in LFC from baseline, the study?s primary efficacy endpoint, were up to 68.5% in subjects receiving pemvidutide compared to 4.4% in subjects receiving placebo. Responder analyses showed that up to 94.4% of subjects receiving pemvidutide achieved =30% relative reduction in LFC, an important predictor of MASH resolution and fibrosis improvement, compared to only 4.2% receiving placebo (p <0.0001 vs. placebo, respectively).

Moreover, up to 55.6% of subjects receiving pemvidutide achieved LFC normalization, defined as an LFC =5%, compared to 0% of subjects receiving placebo. Significant reductions in body weight and established markers of MASH inflammatory activity, including alanine aminotransferase (ALT) and corrected T1 (cT1) MRI imaging, were also observed. Pemvidutide was well-tolerated, with a 2.9% rate of adverse event discontinuations in subjects receiving pemvidutide, and no severe or serious adverse events.