Dal-GenE-2 Clinical Trial

Dal-GenE-2 (Dal-302), a phase III, double-blind, randomized placebo-controlled study, will evaluate the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal MI in 2,000 patients with a documented recent acute coronary syndrome (ACS) and the AA genotype at variant rs1967309 in the ADCY9 gene.

The study will be conducted in 2,000 patients. The first patient is expected Q3 2023 with an interim efficacy analysis in 2026, and trial completion anticipated in 2027. The study will be coordinated by the Montreal Health Innovations Coordinating Centre (MHICC).

This confirmatory trial follows the results of the dal-GenE trial which showed a 21% relative risk reduction (RRR) in fatal and non-fatal MI in 6,149 patients across 34 countries, and a 45% RRR in 1,200 patients in North America and confirmed the safety profile of dalcetrapib.