Phase 2a pilot study aims to inform the design and conduct of future
Phase 3 research in this population
Cadisegliatin is a potential first-in-class oral therapy being evaluated as an adjunct to insulin for the treatment of T1D
HIGH POINT, N.C., Oct. 27, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company advancing cadisegliatin, a novel, investigational oral therapy for type 1 diabetes (T1D), today announced that the first participant has been randomized in its Phase 2a Hybrid CATT1 pilot study evaluating cadisegliatin in individuals with T1D who use hybrid closed-loop (HCL) insulin delivery systems. The Company expects the results to provide insight into cadisegliatin’s potential in this growing segment of the T1D population and to inform additional clinical studies.
Automated insulin delivery (AID) systems, also called closed-loop or artificial pancreas systems, combine a continuous glucose monitor (CGM), an insulin pump, and a control algorithm to adjust insulin delivery automatically. HCL systems, the most common type of AID, automate basal insulin adjustments but still require the user to, for example, manage insulin dosing for meals or periods of exercise.
“Although HCL systems have improved the lives of people living with T1D, the risk and associated fear of hypoglycemia remain a significant burden on their day-to-day lives,” said Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics. “As we advance our cadisegliatin program, this study seeks to deepen our understanding of how cadisegliatin may help improve glycemic control and reduce the burden of hypoglycemia for people who use HCL insulin delivery systems.”
An estimated 2.1 million people in the United States live with T1D,i with up to 40% of people with T1D now using AID systems.ii, iii, iv Yet over 40% of people with T1D who use AID systems still do not achieve the target A1C of less than 7.0%.v
Earlier this month, vTv Therapeutics announced the completion of enrollment in its Phase 3 CATT1 study of cadisegliatin for T1D. Because the Phase 3 study only enrolled participants using insulin pens or insulin pumps in an open-loop fashion, this Phase 2a pilot study will provide complementary insights into cadisegliatin’s metabolic effects in individuals using AID systems and inform larger future clinical studies.
About the Phase 2a Hybrid CATT1 Pilot Study
The Phase 2a Cadisegliatin as Adjunctive Therapy to Insulin in Participants with T1D Who Are Using HCL Systems (Hybrid CATT1) study is a double-blind, randomized, placebo-controlled, two-way crossover study assessing cadisegliatin as an adjunctive treatment to insulin in adults with T1D using HCL insulin delivery systems.
The multicenter study is expected to enroll approximately 40 adults with T1D who have used an HCL system for at least three months before screening. The primary objective is to evaluate the effect of cadisegliatin on continuous glucose monitoring (CGM)-based measures of glycemic control, including Time in Range (TIR), following six weeks of treatment. The study also includes standardized mixed-meal tolerance tests to evaluate the effects of cadisegliatin on postprandial glucose excursions.
For more information on the Phase 2a Hybrid CATT1 Pilot Study, visit https://clinicaltrials.gov/study/NCT07616206.
About Cadisegliatin
Cadisegliatin (TTP399) is a novel, oral, liver-selective small molecule glucokinase activator being investigated in the U.S. as a potential first-in-class adjunctive treatment for T1D. In nonclinical studies, cadisegliatin acted selectively on the liver and increased the activity of glucokinase independently of insulin. These studies support clinical investigation of whether cadisegliatin can improve 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 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.
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, a potential first-in-class oral glucokinase activator being investigated in a U.S. Phase 3 study for the treatment of T1D. 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.
Forward-Looking Statements
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 variations or comparable terminology. All statements other than statements of historical facts contained in this release, including statements regarding 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, mergers, 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
jfraunces@lifesciadvisors.com
Media Contact
Caren Begun
TellMed Strategies
201-396-8551
caren.begun@tmstrat.com
i Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2026 update (2023 estimates)
ii Tandem Diabetes Care, Inc. Investor Presentation, August 2026, slide 4. Available at investor.tandemdiabetes.com.
iii Beta Bionics, Inc. Investor Presentation, September 2026, slide 6. Available at investors.betabionics.com
iv Insulet Corporation. Investor Presentation, September 2026, slide 10. Available at investors.insulet.com
v Wu Z, Rabasa-Lhoret R, et al. Despite lower haemoglobin A1c with second-generation automated insulin delivery systems, mental burden remains high for all adults with type 1 diabetes. Diabetes Obes Metab. 2026;28(2):1150-1159. doi:10.1111/dom.70299
