vTv Therapeutics and M42’s IROS Announce Submission of Phase 2 Clinical Study Protocol for Cadisegliatin in Type 2 Diabetes to the United Arab Emirates Department of Health

Rhea-AI Summary

vTv Therapeutics (Nasdaq: VTVT) submitted a Phase 2 clinical study protocol for cadisegliatin to the Abu Dhabi Department of Health in collaboration with M42’s IROS.

The double-blind, randomized, placebo-controlled trial will be the longest cadisegliatin study to date: a 12-month trial enrolling approximately 300 insulin-treated type 2 diabetes patients across UAE, Jordan, and Tunisia, with three arms (400 mg once daily, 800 mg once daily, and placebo). The first patient first visit is expected in Q1 2026. vTv is the regulatory sponsor and M42 is funding the study.

Positive

• 12-month Phase 2 trial enrolling ~300 insulin-treated T2D patients
• Three-arm design with 400 mg and 800 mg once-daily dose groups
• Trial spans UAE, Jordan, and Tunisia, expanding geographic footprint
• First patient visit expected Q1 2026

Negative

• Protocol submitted but no safety or efficacy results yet
• Study limited to UAE, Jordan, Tunisia—may limit global representation

Key Figures

Trial duration 12 months Planned Phase 2 cadisegliatin study in insulin-treated T2D

Planned enrollment approximately 300 patients Type 2 diabetes patients on insulin for glycemic control

Dose group 1 400 mg once daily Cadisegliatin arm in Phase 2 trial

Dose group 2 800 mg once daily Higher-dose cadisegliatin arm in Phase 2 trial

Trial arms 3 arms Two cadisegliatin doses plus placebo control

Trial start timing Q1 2026 First patient first visit expected

Current price $34.41 Prior to Phase 2 protocol news

52-week range $13.15–$36.03 Price range before this announcement

Market Reality Check

$39.60 Last Close

Volume Volume 10,014 is slightly below 20-day average 10,798, indicating no outsized trading interest pre‑announcement. normal

Technical Price $34.41 is trading above 200-day MA $20.18 and 4.5% below the 52-week high of $36.03.

Peers on Argus 1 Down

VTVT was down 2.08% while key biotech peers RLMD, SER, JUNS, PDSB, and PYPD also showed declines, and momentum scanner flagged CUE down 21.11%, suggesting broader biotech weakness but not a confirmed coordinated sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 06	Earnings and update	Positive	+5.1%	Q3 results, cash increase, CATT1 progress, new patent on cadisegliatin.
Oct 09	Board appointments	Positive	+3.5%	New Scientific Advisory Board members to guide cadisegliatin development.
Sep 15	Scientific conference	Positive	+3.3%	EASD presentations on TTP-RA and cadisegliatin for Type 1 diabetes.
Sep 03	Investor conferences	Neutral	-1.8%	Announcement of participation in two September investor conferences.
Sep 03	Investor conferences	Neutral	+2.5%	Details on H.C. Wainwright and Morgan Stanley conference participation.

Pattern Detected

Shares have generally reacted positively to clinical and strategic updates, with mostly aligned moves and only occasional divergence on neutral conference-related news.

Recent Company History

Over the last few months, vTv advanced cadisegliatin and strengthened its balance sheet. On Nov 6, 2025, Q3 results highlighted $98.5M cash after an $80M private placement and progress on the Phase 3 CATT1 trial, with a 5.07% positive reaction. Earlier, new Scientific Advisory Board appointments on Oct 9, 2025 and CATT1- and T1D-focused presentations at EASD on Sep 15, 2025 also saw positive moves. Today’s Phase 2 T2D protocol submission extends the cadisegliatin story into a new diabetes population.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-10-03

An effective S-3 shelf filed on Oct 3, 2025 registers up to 15,876,640 Class A shares with related warrants and pre-funded warrants, giving the company flexibility to raise capital as needed. The filing also reiterates prior clinical data and notes earlier going-concern language in audited 2024 financials.

Market Pulse Summary

This announcement details a 12‑month, double-blind Phase 2 trial of cadisegliatin as an oral adjunctive therapy to insulin in approximately 300 people with Type 2 diabetes across the UAE, Jordan, and Tunisia. It complements ongoing Phase 3 work in Type 1 diabetes highlighted in prior updates. Investors may track trial initiation in Q1 2026, enrollment progress, emerging safety data, and how results could intersect with the company’s existing capital-raising flexibility.

Key Terms

adjunctive therapy medical

"cadisegliatin, a potential first-in-class oral adjunctive therapy to insulin"

Adjunctive therapy is a treatment given in addition to a primary therapy to boost its effectiveness, reduce side effects, or treat related symptoms — like adding a side dish to make a main meal work better. For investors, evidence that an adjunctive therapy improves outcomes, safety, or convenience can expand a product’s use, support stronger regulatory labeling and reimbursement, and increase commercial potential by reaching more patients or strengthening a therapy’s market position.

double-blind medical

"will be a 12-month, double-blind, randomized, placebo-controlled trial"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

randomized medical

"will be a 12-month, double-blind, randomized, placebo-controlled trial"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

placebo-controlled medical

"will be a 12-month, double-blind, randomized, placebo-controlled trial"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

glycemic control medical

"patients with type 2 diabetes who are treated with insulin for glycemic control"

Management of blood sugar levels over time to keep them within a target range, like using a thermostat to maintain a comfortable room temperature. It matters to investors because better glycemic control reduces complications, hospital visits and long-term costs, which affects demand for drugs, devices and services, reimbursement decisions, and a healthcare product’s market value and revenue potential.

AI-generated analysis. Not financial advice.

Trial to assess cadisegliatin as potential adjunctive therapy to insulin in patients with T2D

HIGH POINT, N.C., Dec. 18, 2025 (GLOBE NEWSWIRE) -- 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.

About Cadisegliatin

Cadisegliatin (TTP399) is a novel, oral small molecule, liver-selective glucokinase activator being investigated in the US as a potential first-in-class oral adjunctive treatment for type 1 diabetes (T1D). 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. Cadisegliatin has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).

Cadisegliatin is under investigation, and the 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.

About vTv Therapeutics

vTv Therapeutics is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates intended to help treat people living with diabetes and other chronic diseases. vTv’s clinical pipeline is led by cadisegliatin, currently in a US Phase 3 trial, a potential first-in-class oral glucokinase activator being investigated for the treatment of type 1 diabetes. vTv and its development partners are investigating multiple molecules across different indications for chronic diseases. Learn more at vtvtherapeutics.com or follow the company on LinkedIn or X.

About IROS

IROS, part of the M42 group, a global tech-enabled health powerhouse, is a pioneering UAE-based Clinical Research Organization (CRO) dedicated to advancing excellence in clinical research and real-world evidence. Its mission is to leverage cutting-edge technologies to innovate in health and drive breakthroughs in clinical research. By conducting high-quality research and achieving groundbreaking insights, IROS aims to improve patients’ lives and shape the health landscape.

IROS’ comprehensive offerings span all therapeutic domains, positioning it as a leader in regional medical research. With a team of high-caliber experts committed to precision, IROS offers both full-service solutions and tailored services to meet the unique needs of its partners. The organization continually integrates the latest technologies and techniques to drive innovation and excellence.

For more information, please visit, https://iros.ai

Forward-Looking Statement

This release contains forward-looking statements, which involve risks and uncertainties. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and, in each case, their negative or other various or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding the satisfaction of the closing conditions set forth in the securities purchase agreement, the expected use of proceeds from the offering, the timing of our clinical trials, the anticipated effect of Phase 3 topline data on the Company, the benefits of cadisegliatin to people living with T1D, our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause our results to vary from expectations include those described under the heading “Risk Factors” in our Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and our other filings with the SEC. These forward-looking statements reflect our views with respect to future events as of the date of this release and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of the date of this release and, except as required by law, we undertake no obligation to update or review publicly any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this release. We anticipate that subsequent events and developments will cause our views to change. Our forward-looking statements do not reflect the potential impact of any future acquisitions, merger, dispositions, joint ventures, or investments we may undertake. We qualify all our forward-looking statements by these cautionary statements.

Investor Contact
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com

Media Contact
Caren Begun
TellMed Strategies
201-396-8551
caren.begun@tmstrat.com

FAQ

What is the design of vTv Therapeutics' Phase 2 cadisegliatin trial (VTVT)?

A 12-month, double-blind, randomized, placebo-controlled Phase 2 trial with ~300 insulin-treated type 2 diabetes patients and three arms (400 mg, 800 mg, placebo).

When and where will the first patient visit for VTVT cadisegliatin trial occur?

The first patient first visit is expected in Q1 2026 at sites in UAE, Jordan, and Tunisia.

What doses of cadisegliatin will be tested in the VTVT Phase 2 study?

Two once-daily oral doses: 400 mg and 800 mg, plus a placebo control.

Who is sponsoring and funding the VTVT cadisegliatin Phase 2 trial?

vTv Therapeutics is the regulatory sponsor and M42 (IROS) is funding the study.

What is the primary purpose of the VTVT Phase 2 cadisegliatin study?

To evaluate the safety and efficacy of cadisegliatin as an oral adjunctive therapy to insulin in type 2 diabetes over 12 months.