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The company announced that the last patient completed their final visit in its TRILOGY 1 pivotal Phase 3 clinical trial of CaPre.
Acasti Pharma (TSXV:ACST, NASDAQ:ACST) has announced that the last patient has completed their final visit in the TRILOGY 1 Phase 3 clinical trial of CaPre.
As quoted in the press release:
Topline results for TRILOGY 1 are expected to be reported as planned in December 2019. The Company also expects the last patient to complete their final visit in TRILOGY 2 in early January 2020, with topline results expected towards the end of January 2020.
Topline results will include a readout of the primary endpoint, which is intended to show CaPre’s overall impact on lowering triglycerides (TGs) after 12 weeks compared to placebo. Safety and tolerability (e.g. overall adverse events (AE) and serious AE rate, any discontinuation due to AEs, and AEs of special interest such as gastrointestinal events) will also be reported.
The Company currently expects that topline results will not include any secondary or exploratory endpoints. The important secondary and exploratory endpoint results are expected to be completed before the end of March 2020, and will include: 1) additional TG secondary endpoints, including TG reduction at Week 26, which is intended to show CaPre’s persistence of effect, TG reduction in various subgroups to show consistency of effect (such as patients stratified with baseline qualifying TG levels of ≤750 mg/dL vs. >750 mg/dL), and a comparison of TG reduction in patients using and not using statins at baseline; 2) Non-HDL-C; 3) VLDL-C; 4) HDL-C; 5) LDL-C and HbA1c.