1. vTv Therapeutics announced a Phase 2 trial for cadisegliatin. 2. Cadisegliatin targets boosting insulin efficacy in type 2 diabetes patients. 3. The trial will enroll around 300 patients over 12 months. 4. Study locations include UAE, Jordan, and Tunisia. 5. Cadisegliatin holds Breakthrough Therapy designation from the FDA.
FAQ
Why Bullish?
With a new clinical trial and Breakthrough designation, VTVT's stock could attract investor interest similar to patterns seen previously with other biotech trials. Positive trial results can lead to significant price increases, as seen with similar companies.
How important is it?
The announcement of the Phase 2 trial increases future revenue potential, directly impacting investor sentiment. The Breakthrough designation enhances the drug’s visibility and perceived value.
Why Long Term?
The effects of the trial results may take time to be realized, influencing VTVT's trajectory over the next year similarly to past Phase 2 developments in the biotech sector that drove longer-term growth.
vTv Therapeutics (Nasdaq: VTVT) Submits Phase 2 Study Protocol for Cadisegliatin in Type 2 Diabetes
Date: December 18, 2025
Source: GlobeNewsWire
Overview of the Phase 2 Clinical Study
vTv Therapeutics Inc. (Nasdaq: VTVT), a prominent biopharmaceutical company, has announced the submission of a Phase 2 clinical study protocol. This submission was made to the Department of Health (DOH) in Abu Dhabi, in collaboration with M42's Insights Research Organization & Solutions (IROS). The study aims to evaluate the safety and efficacy of cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin, specifically for individuals living with type 2 diabetes.
This clinical trial represents one of the most comprehensive investigations into cadisegliatin to date, featuring a duration of **12 months** and involving approximately **300** insulin-treated patients with type 2 diabetes.
Details of the Clinical Trial
The Phase 2 study will be a double-blind, randomized, placebo-controlled trial. Participants will be assigned to one of three groups:
- Cadisegliatin 400 mg (once daily)
- Cadisegliatin 800 mg (once daily)
- Placebo control group
The trial is set to occur across the UAE, Jordan, and Tunisia, with patient enrollment expected to start in early 2026.
Strategic Insights from Leadership
Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics, emphasized the significance of this collaboration, stating: “Through our collaboration with M42, we continue to investigate cadisegliatin’s potential as an adjunctive therapy to insulin for people living with diabetes.” This study is noted to expand cadisegliatin's reach geographically.
Thomas Strack, MD, Chief Medical Officer at vTv Therapeutics, added: “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.”
Furthermore, Islam Altantawy, General Manager at IROS, remarked on the collaboration's impact, highlighting the high prevalence of type 2 diabetes among UAE nationals: “We see potential for cadisegliatin to assist in glucose management efforts in this population.”
About Cadisegliatin
Cadisegliatin (TTP399) is a novel, liver-selective glucokinase activator aimed at improving glycemic control. Currently under investigation in the U.S. as a potential treatment for both type 1 and type 2 diabetes, cadisegliatin has already received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
It is important to note that while cadisegliatin shows promise, its safety and efficacy have not yet been established, and there are no guarantees of regulatory approval or commercial availability.
About vTv Therapeutics
vTv Therapeutics focuses on developing innovative oral therapies to address chronic diseases, particularly diabetes. Its current pipeline is led by cadisegliatin, which is advancing towards clinical trials in various settings.
For further information, visit vtvtherapeutics.com or follow them on social media platforms.
About IROS
IROS, part of the M42 group, stands as a leading Clinical Research Organization in the UAE, dedicated to advancing clinical research quality using cutting-edge technologies. The organization aims to foster breakthroughs and improve patient outcomes across various therapeutic domains.
Forward-Looking Statements
This announcement includes forward-looking statements that carry inherent risks and uncertainties. Actual results may differ materially from those anticipated. Stakeholders are cautioned to consider these factors when evaluating forward-looking statements provided in this release.