DCCR (Essentialis) shows promise in Phase IIb trial for Hypertriglyceridemia

New results have been announced for a Phase IIb trial of DCCR, from Essentialis, demonstrating a reduction in triglyceride (TG) levels by 30 to 40 percent in Hypertriglyceridemia patients whose TG levels exceeded 500 mg/dL (Very High Triglycerides [VHTG]). VHTG are a well-characterized risk factor for acute Pancreatitis. About half of the patients were in the atorvastatin combination sub-group, randomized to receive either DCCR 290 mg or placebo in combination with atorvastatin (Lipitor) 20 mg for 18 weeks. The remainder were in the monotherapy/fenofibrate combination subgroup, randomized to receive either DCCR 290 mg or placebo for 12 weeks, followed by co-administration of fenofibrate (Trilipix) 135 mg for another six weeks. Results show that in combination with statin, DCCR (290 mg) resulted in placebo-adjusted median reductions in TG of 28%, in VLDL-C of 51%, in non-HDL-C of 16%, and an increase in HDL-C of 11% after 18 weeks of treatment. In statin treated subjects, there was no change in mean LDL-C. In combination with fenofibrate, treatment with DCCR resulted in median reductions in TG of 78%, in non-HDL-C of 34%, and an increase in HDL-C of 38%. Through 18 weeks, treatment with DCCR resulted in nearly a 40% improvement in HOMA-IR, a measure of insulin resistance, and a reduction in median weight of more than 3 kilograms, compared to a worsening of HOMA-IR (+13%) and no change in median weight in the placebo-treated subjects. The incidence, severity and nature of adverse events in the DCCR arm were comparable to placebo.