GlobeNewswire·Dec 18, 2025, 4:05 PM ET

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

vTv Therapeutics submitted a Phase 2 clinical study protocol for cadisegliatin to the Department of Health Abu Dhabi in collaboration with M42's IROS.
The trial is a 12-month, double-blind, randomized, placebo-controlled study enrolling approximately 300 patients with type 2 diabetes treated with insulin.
Participants will be randomized into three arms: two cadisegliatin dose groups (400 mg & 800 mg once daily) & one placebo control group.
The study will take place in the UAE, Jordan, & Tunisia, with the first patient visit expected in Q1 2026.
vTv Therapeutics serves as the regulatory sponsor, while M42 funds the study.
Cadisegliatin is a liver-selective glucokinase activator with FDA Breakthrough Therapy designation, currently investigated as a potential first-in-class oral adjunctive therapy to insulin.
The trial aims to evaluate the safety & efficacy of cadisegliatin over one year to address glycemic control challenges in insulin-dependent type 2 diabetes patients.
vTv Therapeutics is a late-stage biopharmaceutical company with cadisegliatin also under investigation in a US Phase 3 trial for type 1 diabetes.