vTv Therapeutics Initiates Phase 2 Trial of Cadisegliatin for Type 2 Diabetes in Middle East and North Africa
Key Insights
vTv Therapeutics and M42 (search)'s IROS (search) have submitted a Phase 2 clinical study protocol to UAE health authorities to evaluate cadisegliatin as an oral adjunctive therapy to insulin in type 2 diabetes (search) patients.
The 12-month, placebo-controlled trial will enroll approximately 300 patients across UAE, Jordan, and Tunisia, representing the longest cadisegliatin study to date.
Participants will be randomized to receive either 400 mg or 800 mg of cadisegliatin once daily or placebo, with the first patient visit expected in Q1 2026.
vTv Therapeutics Inc. (Nasdaq: VTVT) announced the submission of a Phase 2 clinical study protocol to the Department of Health Abu Dhabi to evaluate cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin, in people living with type 2 diabetes (search). The study, developed in collaboration with M42 (search)'s Insights Research Organization & Solutions (IROS (search)), represents the longest trial investigating cadisegliatin to date.
Trial Design and Patient Population
The 12-month, double-blind, randomized, placebo-controlled trial will enroll approximately 300 patients with type 2 diabetes (search) 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 across three countries in the Middle East and North Africa region: the UAE, Jordan, and Tunisia, with the first patient first visit expected in the first quarter of 2026. This geographic expansion represents a strategic move to evaluate the therapy in a region with significant diabetes burden.
Addressing Regional Healthcare Needs
"Given that the prevalence of type 2 diabetes (search) among UAE nationals is among the highest globally, we see potential for cadisegliatin to assist in glucose management efforts in this population," said Islam Altantawy, General Manager at IROS (search). The collaboration positions both companies 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.
Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics, emphasized the strategic importance of the partnership: "Through our collaboration with M42 (search), we continue to investigate cadisegliatin's potential as an adjunctive therapy to insulin for people living with diabetes. This study also expands the potential geographic footprint for cadisegliatin."
Extended Observation Period
The study's 12-month duration will provide extended observation of cadisegliatin's impact as an investigational oral adjunctive therapy. "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 (search), allowing for extended observation of the impact of our investigational oral adjunctive therapy," said Thomas Strack, MD, Chief Medical Officer of vTv Therapeutics.
Mechanism of Action and Development Status
Cadisegliatin (TTP399) is a novel, oral small molecule, liver-selective glucokinase (search) activator. In non-clinical studies, cadisegliatin, acting selectively on the liver, increased the activity of glucokinase independently from insulin, which supports clinical investigation of improvement in glycemic control through hepatic glucose uptake and glycogen storage.
The drug candidate has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and is currently being investigated in the US as a potential first-in-class oral adjunctive treatment for type 1 diabetes (search), with a Phase 3 trial ongoing.
Collaboration Structure
Under the collaboration agreement between vTv and M42 (search), vTv serves as the regulatory sponsor of the trial while M42 is funding the study. This partnership leverages IROS (search)'s position as a leading UAE-based contract research organization with comprehensive offerings spanning all therapeutic domains and expertise in regional medical research.
Cadisegliatin remains under investigation, and its safety and efficacy have not been established. There is no guarantee that this product will receive health authority approval or become commercially available for the use being investigated.