vTv Therapeutics Submits Phase 2 Cadisegliatin Study Protocol To Abu Dhabi DOH, Partnering With M42’s IROS For 12-Month Insulin Adjunct Trial

vTv Therapeutics Inc., a late-stage biopharmaceutical company, announced that a Phase 2 clinical study protocol for cadisegliatin has been submitted to the Department of Health (DOH) Abu Dhabi. The protocol was developed in collaboration with M42’s Insights Research Organization & Solutions (IROS), a leading contract research organization based in the United Arab Emirates. 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 Phase 2 trial represents the longest study of cadisegliatin to date. It will be a 12-month, double-blind, randomized, placebo-controlled trial enrolling approximately 300 patients with type 2 diabetes who are treated with insulin to manage their blood glucose levels. Participants will be assigned to one of three groups: two cadisegliatin dose groups (400 mg and 800 mg once daily) or a placebo control group. The trial will be conducted across sites in the UAE, Jordan, and Tunisia, with the first patient expected to be enrolled in the first quarter of 2026.

Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics, said that the collaboration with M42 allows the company to further explore cadisegliatin’s potential as an adjunctive therapy to insulin. He also noted that the study expands the geographic reach for evaluating cadisegliatin.

Thomas Strack, M.D., Chief Medical Officer of vTv Therapeutics, added that this trial will provide the opportunity to assess the safety and efficacy of cadisegliatin over the course of a year in patients with insulin-dependent type 2 diabetes, offering extended observation of the therapy’s impact.

Islam Altantawy, General Manager at IROS, stated that the collaboration provides a chance to explore a therapy that could potentially benefit millions of people with type 2 diabetes who struggle to maintain glycemic control. He emphasized that, given the high prevalence of type 2 diabetes among UAE nationals, cadisegliatin may play an important role in managing glucose levels in this population. Under the terms of the collaboration, vTv Therapeutics serves as the regulatory sponsor of the trial, while M42 is funding the study.