TRILOGY, an acronym derived from “Phase 3 Studies of CaPre in Lowering Very High Triglycerides,” is a double-blind, placebo-controlled, 26-week, two-trial Phase 3 clinical program designed to evaluate the safety and efficacy of CaPre in patients with severe hypertriglyceridemia. TRILOGY 1 and TRILOGY 2 is running in parallel and will randomize a total of approximately 500 patients. The program is being conducted at approximately 150 sites across the U.S., Canada and Mexico.
The primary endpoint of the identical trials is to determine the efficacy of CaPre 4 grams daily compared to placebo in lowering TG levels after 12 weeks of treatment, in subjects with fasting triglyceride levels between 500 mg/dL and 1500 mg/dL. The persistence of the effect of CaPre on TGs over 26 weeks of treatment will also be evaluated. Numerous secondary endpoints will assess the effect of CaPre on patients’ broader lipid profile and certain exploratory metabolic, glycemic diabetic markers, inflammatory and cardiovascular risk markers. Safety will also be evaluated.
The study was designed to provide at least 90% power to detect a difference of at least a 20% decrease from baseline in triglycerides between CaPre and placebo. Acasti expects to concurrently report topline results from the parallel trials by the end of 2019.
Additional information on the TRILOGY program can be found at www.clinicaltrials.gov, with the NCT Identifiers #03398005 and #03361501.