Diazoxide choline controlled release: Phase IIb data

Essentialis reported data from a double-blind Phase IIb trial in 44 non-diabetics with fasting triglyceride levels of >=500 mg/dL evaluating DCCR in combination with a statin or with fenofibrate. In combination with Lipitor atorvastatin, DCCR led to placebo-adjusted median reductions from baseline to week 18 of 28% in triglycerides, 51% in VLDL cholesterol and 16% in non-HDL-C, as well as an increase of 11% in HDL-C. There was no change in mean LDL-C between treatment groups, but the company said all patients receiving DCCR with an LDL-C >100 mg/dL at baseline showed improvements on the endpoint. Essentialis said the reduction in triglycerides, the primary endpoint, was significant at days 14, 28 and 56 (p=0.04, p=0.02 and p=0.003, respectively).

In combination with Trilipix fenofibric acid, DCCR led to median reductions from baseline to week 18 of 78% in triglycerides and 34% in non-HDL-C, as well as an increase of 38% in HDL-C. Overall, DCCR led to an almost 40% improvement in HOMA-IR and a >3 kg reduction in median body weight through week 18 compared to a >13% worsening of HOMA-IR and no change in median body weight for placebo. The incidence, severity and nature of adverse events in the DCCR arm were comparable to placebo. Patients received 290 mg DCCR or placebo in combination with Lipitor for 18 weeks, or 290 mg DCCR or placebo alone for 12 weeks followed by co-administration with Trilipix for an additional 6 weeks. ...