vTv Therapeutics Announces First Participant Randomized in Phase 2a Pilot Study Evaluating Cadisegliatin in Individuals with Type 1 Diabetes (T1D) Using Hybrid Closed-Loop (HCL) Insulin Delivery Systems

The pilot extends cadisegliatin research to hybrid closed-loop users, a population not enrolled in the Phase 3 CATT1 study.

Rhea-AI Summary

vTv Therapeutics (VTVT) randomized the first participant in its Phase 2a Hybrid CATT1 pilot study of cadisegliatin in type 1 diabetes. The study evaluates the investigational oral drug alongside insulin in adults using hybrid closed-loop systems, which automate some insulin delivery but still require user input.

The double-blind, placebo-controlled, two-way crossover study is expected to enroll approximately 40 adults. Its primary objective is to assess glucose-monitor-based measures of blood sugar control, including time within a target range, after six weeks of treatment. Standardized meal tests will assess blood sugar changes after meals. The company expects the pilot to inform future Phase 3 research in this population. Enrollment in the separate Phase 3 CATT1 study, limited to participants using insulin pens or open-loop pumps, was completed earlier this month.

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Positive

• Moderate pointFDA Breakthrough Therapy designation granted to cadisegliatin.
• Minor pointFirst participant randomized in Phase 2a Hybrid CATT1 advances cadisegliatin testing alongside insulin in hybrid closed-loop users.
• Minor point. Forward-looking: it has not happened yet and may not happen.Approximately 40 adults expected in the pilot, which the company expects to inform future Phase 3 research.
• Minor pointPhase 3 CATT1 enrollment completed earlier this month in participants using insulin pens or open-loop pumps.

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• None.

Key Figures

Expected enrollment: Approximately 40 adults Treatment duration: Six weeks Prior HCL-system use: At least three months

Expected enrollment

Approximately 40 adults

Phase 2a Hybrid CATT1 pilot study

Treatment duration

Six weeks

Assessment of CGM-based glycemic-control measures

Prior HCL-system use

At least three months

Required before screening

Previous Clinical trial Reports

1 past event · Latest: Oct 05

Same Type 1 event

1. Oct 05

   Phase 3 enrollment

   24h Move

   -0.8%

   Enrollment in the same cadisegliatin CATT1 program was complete, with 166 participants randomized.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

double-blind, placebo-controlled, crossover study, continuous glucose monitoring, +1 more

5 terms

double-blind medical

"a double-blind, randomized, placebo-controlled, two-way crossover study"

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.

placebo-controlled medical

"a double-blind, randomized, placebo-controlled, two-way crossover study"

"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.

crossover study medical

"a double-blind, randomized, placebo-controlled, two-way crossover study"

A crossover study is a clinical trial design where the same participants receive two or more treatments one after the other, with a break between them, so each person acts as their own comparison. For investors, this matters because it can produce clearer comparisons with fewer participants and faster results than separate-group trials, helping assess a drug’s effectiveness or side effects sooner, though results can be affected if one treatment’s effects carry over into the next.

continuous glucose monitoring medical

"continuous glucose monitoring (CGM)-based measures of glycemic control"

Continuous glucose monitoring is a system that tracks blood sugar levels in real-time throughout the day and night. It provides constant updates, similar to a car's dashboard showing speed and fuel level at all times. For investors, advancements in this technology can signal progress in health monitoring devices, which may influence the growth and valuation of companies in the healthcare sector.

breakthrough therapy designation regulatory

"Cadisegliatin has been granted Breakthrough Therapy designation"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

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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

FAQ

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What is vTv Therapeutics testing in the Phase 2a Hybrid CATT1 study?

The study evaluates cadisegliatin alongside insulin in adults with type 1 diabetes using hybrid closed-loop insulin delivery systems. Its primary objective is to assess continuous-glucose-monitor measures of blood sugar control, including time within a target range, following six weeks of treatment.

Who is eligible for vTv Therapeutics' Hybrid CATT1 pilot study?

The study is expected to enroll approximately 40 adults with type 1 diabetes who have used a hybrid closed-loop insulin delivery system for at least three months before screening.