vTv & M42 Target Diabetes Crisis with Novel Drug Trial in Middle East

HIGH POINT, NC – December 18, 2025 – In a move that converges cutting-edge biotechnology with a pressing regional health crisis, vTv Therapeutics and Abu Dhabi-based M42 have submitted plans for a major clinical trial for a new type 2 diabetes drug, cadisegliatin. The Phase 2 study protocol, submitted to the United Arab Emirates (UAE) Department of Health, marks a significant step in developing what could be a first-in-class oral therapy for millions of patients who struggle to control their blood sugar with insulin alone.

The collaboration will launch a 12-month, double-blind, randomized, placebo-controlled trial—the longest to date for cadisegliatin—enrolling approximately 300 patients with type 2 diabetes. The study, set to begin in the first quarter of 2026, will span the UAE, Jordan, and Tunisia, all regions grappling with some of the highest diabetes prevalence rates in the world.

“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.”

A New Mechanism for a Global Epidemic

Cadisegliatin is not just another diabetes pill. It represents a novel approach to glucose management. As a liver-selective glucokinase activator, it works by targeting a key enzyme, glucokinase, which acts as the liver's glucose sensor. By activating this enzyme, cadisegliatin helps the liver take up and store more glucose from the blood, effectively lowering blood sugar levels in a way that is independent of insulin. This mechanism is fundamentally different from most existing oral diabetes medications.

Previous generations of glucokinase activators were hampered by side effects, including an increased risk of hypoglycemia (dangerously low blood sugar) and adverse effects on blood lipids. vTv Therapeutics designed cadisegliatin to be liver-selective, aiming to minimize action on the pancreas and thereby sidestep these historical challenges. The goal is to provide robust glycemic control without the common side effects that complicate diabetes management.

“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,” stated Thomas Strack, MD, Chief Medical Officer of vTv Therapeutics.

The drug's potential has already been recognized. In the United States, cadisegliatin is in a pivotal Phase 3 trial for Type 1 Diabetes and has been granted Breakthrough Therapy designation by the FDA—a status reserved for drugs that may demonstrate substantial improvement over available therapies for serious conditions.

Biotech's Global Playbook: A Strategic Partnership

The structure of this collaboration offers a compelling look at the modern playbook for global drug development. Under the agreement, M42, a global health-tech powerhouse, is funding the entire Phase 2 study. vTv Therapeutics, a late-stage U.S. biopharmaceutical company, serves as the regulatory sponsor, lending its deep expertise in the drug's science and clinical history.

This arrangement is highly strategic for both parties. For vTv, it significantly de-risks the financial burden of a costly, year-long international trial. This allows the company to preserve its own capital—bolstered by a recent $80 million financing—to focus on its flagship Phase 3 trial for cadisegliatin in Type 1 Diabetes in the U.S. It’s a capital-efficient way to expand the drug's potential indications and geographic reach simultaneously.

For M42 and its clinical research arm, IROS, the partnership is a cornerstone of its mission to transform the MENA region into a hub for advanced medical research. Formed from the merger of G42 Healthcare and Mubadala Health, M42 is leveraging AI, genomics, and vast healthcare infrastructure to tackle global health challenges. By funding and helping to execute this trial, M42 not only invests in a promising therapeutic but also builds critical research capabilities within a region that desperately needs them.

“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.

From Regional Crisis to Research Hub

The decision to conduct this trial in the UAE, Jordan, and Tunisia is no coincidence. The Middle East and North Africa (MENA) region has the highest prevalence of diabetes in the world, with an estimated 17.6% of adults affected. Projections show this number could nearly double by 2050. In the UAE specifically, prevalence rates are among the highest globally, a fact explicitly cited by IROS as a key driver for the collaboration.

Patients in this region face immense challenges. Beyond the sheer numbers, many struggle to achieve glycemic control even with insulin. The burden of daily injections leads to poor adherence, while cultural factors, low health literacy, and limited access to advanced care create further barriers. The unmet need for a simple, effective oral therapy that can be added to insulin without increasing the risk of hypoglycemia is enormous.

This trial represents a direct response to that crisis. By bringing a cutting-edge clinical investigation to the heart of the epidemic, M42 and vTv are not only gathering crucial data on cadisegliatin but also embedding global innovation within the local healthcare ecosystem. It signals a shift from the region being merely a market for pharmaceuticals to becoming an active participant in their development.

With the first patient visit expected in early 2026, the study will test two different doses of cadisegliatin (400 mg and 800 mg) against a placebo. The findings will be closely watched by endocrinologists, patients, and investors worldwide, as they could validate a new therapeutic class and offer a desperately needed new tool in the global fight against diabetes.