D&D Pharmatech reported publication in Lancet Gastroenterology & Hepatology of 12-week results from its randomized, double-blind, placebo-controlled Phase 2 DD01-DN-02 trial (NCT06410924) evaluating zabopegdutide (DD01) in 67 overweight or obese patients with MASLD/MASH.
The analysis showed rapid, clinically meaningful reductions in liver fat, stiffness and fibrosis biomarkers at 12 weeks that preceded previously reported 48-week biopsy improvements, according to the company.
At 12 weeks, 75.8% of treated subjects achieved at least a 30% reduction in liver fat, 72.7% achieved greater than 50% reduction, and 48.5% achieved normalization of liver fat (<5%); liver stiffness (MRE) and biomarkers pro-C3 and ELF were also significantly reduced.
Zabopegdutide produced progressive weight loss (3.8% at 12 weeks; 6.4% at 24 weeks) and improved glycemic and lipid parameters. Notably, among patients with less than 5% body weight loss by Week 12, liver fat fell 37.4% and liver stiffness fell 19.2%, supporting a weight-loss-independent hepatic effect, while patients with ≥5% weight loss saw larger reductions.
DD01 is a once-weekly pegylated dual GLP-1/glucagon receptor agonist that reached a 40 mg maintenance dose after a two-week titration. The company claims these early non-invasive markers may predict durable histological benefit.
