Safety, pharmacokinetics and efficacy of the novel pan-phosphodiesterase inhibitor ZSP1601 in 36 NASH patients: a double-blinded, placebo-controlled, multiple-dose escalation phase Ib study

pemvidutide achieved mean weight losses of 4.9%, 10.3%, and 9.0% at the 1.2 mg, 1.8 mg**, and 2.4 mg* doses, respectively, vs. 1.6% for subjects receiving placebo (*p < 0.01, **p < 0.005 vs. placebo); subject plots at 1.8 mg (Figure) suggested sustained effects over time.MRI-PDFF analyses following 6 weeks of treatment revealed all 5 subjects with fatty liver (≥5%) at baseline, including some as high as 19.5%, receiving 1.8 mg or 2.4 mg pemvidutide had reductions in LFC to undetectable levels (limit of detection 1.5%), a >90% mean reduction. Conclusion:The rapid and potent reductions in body weight and LFC, including double-digit weight loss in 12 weeks and decreases in LFC to levels below the limit of detection, without the need for dose titration, suggest pemvidutide could be a promising new agent for treatment of NASH and its co-morbidities.