HIGH POINT, N.C., Oct. 05, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company advancing cadisegliatin, a novel oral investigational therapy for type 1 diabetes (T1D), today announced that the Company has completed enrollment of its Phase 3 Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes (CATT1) study. A total of 166 patients have been randomized in the study evaluating cadisegliatin, a potential first-in-class oral, liver-selective glucokinase activator that has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) as an adjunctive therapy to insulin for the treatment of T1D.
"Completing enrollment for the CATT1 study is a significant milestone for vTv, and we're deeply grateful to the study participants whose commitment made this possible," said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. "Cadisegliatin has the potential to reduce the risk of hypoglycemia, which remains a significant unmet need for people living with T1D, and we look forward to completing the study and reporting topline results in mid 2027."
An estimated 9.5 million people worldwide live with T1D, and this number is projected to reach 14.7 million by 2040.i Despite advances in diabetes technology, significant gaps persist in achieving optimal day-to-day glycemic control,ii and hypoglycemia remains a daily burden on the lives of people living with T1D. The CATT1 study is evaluating the potential of cadisegliatin to reduce clinically significant hypoglycemia while improving overall glycemic control.
"This milestone is an important step forward for the cadisegliatin program," said Thomas Strack, MD, Chief Medical Officer of vTv Therapeutics. "Our focus now is maintaining the quality and integrity of the study through completion and continuing the important work of advancing cadisegliatin development toward potential approval."
About the Phase 3 CATT1 Study
Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes (CATT1) (NCT06334133) is a randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of cadisegliatin over six months in individuals with T1D 18 years or older who are on multiple daily insulin injections or continuous subcutaneous insulin infusion, along with continuous glucose monitoring. Participants were randomized to receive cadisegliatin 800 mg once daily, cadisegliatin 800 mg twice daily, or placebo. The primary efficacy endpoint will assess the incidence of level 2 and level 3 hypoglycemic events. Secondary endpoints include changes in hemoglobin A1c (HbA1c), time in target glucose range, and the incidence of diabetic ketoacidosis in cadisegliatin-treated participants compared with placebo. Additional information about the study is available at https://clinicaltrials.gov/study/NCT06334133
About Cadisegliatin
Cadisegliatin (TTP399) is a novel, oral 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
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Media Contact
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TellMed Strategies
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i Ogle G, Wang F, Haynes A, et al, Global type 1 diabetes prevalence, incidence, and mortality estimates 2025: Results from the International diabetes Federation Atlas, 11th Edition, and the T1D Index Version 3.0- Diabetes Research and Clinical Practice- 2025; 225. doi: 10.1016/j.diabres.2025.112277
ii Jacobs PG, Levy CJ, Brown SA, et al. Research Gaps, Challenges, and Opportunities in Automated Insulin Delivery Systems. J Diabetes Sci Technol. 2025;19(4):937-949. doi: 10.1177/19322968251338754
