In both Phase 2 clinical trials (“TRIFECTA” and “COLT”), CaPre was found to be safe and well tolerated at all doses tested, with no serious adverse events that were considered treatment related.
Under both trials, CaPre significantly lowered triglycerides in patients with mild to severe hypertriglyceridemia. But more importantly, CaPre also has demonstrated no deleterious effect on levels of “bad” cholesterol (low-density lipoprotein cholesterol, or LDL-C). Further, the Phase 2 data indicated that CaPre may potentially reduce LDL-C LDL-C is undesirable because it accumulates in the walls of blood vessels, where it can cause blockages (atherosclerosis). In these studies, CaPre also reduced non-HDL-C, which includes all cholesterol contained in the bloodstream except HDL-C and is considered to be a useful marker of cardiovascular disease. The COLT data showed a mean increase of 7.7% in HDL-C with CaPre at 4 grams a day (p=0.07). Further studies are required to demonstrate statistical significance with HDL-C.
The TRIFECTA trial confirmed and supported the positive Phase 2 COLT results, on the safety and efficacy of CaPre for the treatment of patients with hypertriglyceridemia. The TRIFECTA trial’s primary endpoint was met, with patients on 1 gram or 2 grams of CaPre achieving a statistically significant mean placebo-adjusted decrease in triglycerides from baseline. In addition, no deleterious effect on LDL-C (bad cholesterol) and a reduction in non-HDL-C were observed without safety concerns.