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vTv Therapeutics and M42's IROS Announce Submission of Phase 2 Clinical Study Protocol for Cadisegliatin in Type 2 Diabetes to the United Arab Emirates Department of Health
Globenewswire· 2025-12-18 21:05
Core Viewpoint - vTv Therapeutics Inc. has announced a Phase 2 clinical study for cadisegliatin, an oral adjunctive therapy to insulin for type 2 diabetes, in collaboration with M42's Insights Research Organization & Solutions [1][2] Group 1: Clinical Study Details - The Phase 2 study protocol has been submitted to the Department of Health Abu Dhabi and aims to evaluate the safety and efficacy of cadisegliatin over a 12-month period [1] - The trial will enroll approximately 300 patients with type 2 diabetes who are treated with insulin, randomized into three groups: two cadisegliatin dose groups (400 mg and 800 mg once daily) and a placebo control group [1] - The trial will take place in the UAE, Jordan, and Tunisia, with the first patient visit expected in Q1 2026 [1] Group 2: Company and Product Information - Cadisegliatin (TTP399) is a novel oral small molecule being investigated as a potential first-in-class oral adjunctive treatment for type 1 diabetes and has received Breakthrough Therapy designation from the FDA [4][6] - vTv Therapeutics is focused on developing oral, small molecule drug candidates for diabetes and other chronic diseases, with cadisegliatin leading its clinical pipeline [6] Group 3: Collaboration and Market Potential - The collaboration with M42 allows vTv to expand the geographic footprint for cadisegliatin, targeting populations with high prevalence of type 2 diabetes, particularly in the UAE [2][3] - IROS, as the funding partner for the study, aims to leverage its expertise in clinical research to potentially impact the lives of millions with type 2 diabetes [3][7]