vTv Therapeutics And M42's IROS Submits Phase 2 Clinical Study Protocol for Cadisegliatin in Type 2 Diabetes to the United Arab Emirates Department of Health; This Study Constitutes The Longest Trial Investigating Cadisegliatin To Date

vTv Therapeutics Inc. (NASDAQ:VTVT), a late-stage biopharmaceutical company, today announced a Phase 2 clinical study protocol developed in collaboration with M42's Insights Research Organization & Solutions (IROS), a leading United Arab Emirates (UAE)-based contract research organization, has been submitted to the Department of Health (DOH) Abu Dhabi. The study is designed to evaluate the safety and efficacy of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin, in people living with type 2 diabetes. This study constitutes the longest trial investigating cadisegliatin to date and will be a 12-month, double-blind, randomized, placebo-controlled trial enrolling approximately 300 patients with type 2 diabetes who are treated with insulin for glycemic control. Participants will be randomized into three arms: two cadisegliatin dose groups (400 mg and 800 mg once daily) and a placebo control group. The trial will take place in the UAE, Jordan, and Tunisia, with the first patient first visit expected in the first quarter of 2026.

"Through our collaboration with M42, we continue to investigate cadisegliatin's potential as an adjunctive therapy to insulin for people living with diabetes," said Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics. "This study also expands the potential geographic footprint for cadisegliatin."

"The launch of this trial enables us to evaluate the safety and efficacy of cadisegliatin over the course of one year in people with insulin-dependent type 2 diabetes, allowing for extended observation of the impact of our investigational oral adjunctive therapy," said Thomas Strack, MD, Chief Medical Officer of vTv Therapeutics.

"Collaborating with vTv Therapeutics on this Phase 2 study positions us to explore opportunities to potentially impact the lives of millions of people with type 2 diabetes who are not currently able to maintain glycemic control," said Islam Altantawy, General Manager at IROS. "Given that the prevalence of type 2 diabetes among UAE nationals is among the highest globally, we see potential for cadisegliatin to assist in glucose management efforts in this population."

As part of the collaboration between vTv and M42, vTv is the regulatory sponsor of the trial and M42 is funding the study.