vTv Therapeutics announces FDA submission for Phase 3 study of cadisegliatin

vTv Therapeutics announced the submission of the study protocol to the FDA for the Company’s first Phase 3 trial evaluating the safety and efficacy of its lead candidate, cadisegliatin, in adults diagnosed with T1D. This randomized, double-blind, placebo-controlled trial is expected to enroll approximately 150 patients at up to 20 sites in the United States, with the first patient expected to be enrolled in the second quarter of 2024. The Phase 3 study will assess two doses of orally administered cadisegliatin versus placebo in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion, who use a continuous glucose monitor. The primary efficacy endpoint of the study will compare the incidence of Level 2 or Level 3 hypoglycemic events between cadisegliatin-treated subjects and those in the placebo group. This trial further expands vTv’s research into cadisegliatin as an adjunctive therapy to insulin, which also includes a planned Phase 2 trial in patients with type 2 diabetes expected to start in Middle Eastern countries in 2024 in collaboration with vTv’s partner G42 Healthcare Research Technology Projects LLC and its clinical research organization IROS, a UAE-based health technology group.