vTv Therapeutics Announces Completion of Enrollment in Phase 3 CATT1 Study of Cadisegliatin in Type 1 Diabetes (T1D)

The company expects topline results in mid 2027 from a study evaluating low-blood-sugar events and overall glucose control.

Rhea-AI Summary

vTv Therapeutics (VTVT) has completed enrollment in its Phase 3 CATT1 study of cadisegliatin as an adjunct to insulin for type 1 diabetes. The study randomized 166 patients, and the company expects topline results in mid 2027. Cadisegliatin has received FDA Breakthrough Therapy designation for this use.

The randomized, double-blind, placebo-controlled study evaluates efficacy and safety over six months in adults using insulin injections or infusion alongside continuous glucose monitoring. Participants receive cadisegliatin 800 mg once daily, 800 mg twice daily, or placebo. The primary endpoint measures the incidence of level 2 and level 3 hypoglycemic events, episodes of low blood sugar. Secondary endpoints include changes in HbA1c, a measure of blood sugar control, time in target glucose range, and diabetic ketoacidosis incidence compared with placebo. Cadisegliatin remains investigational; its safety and efficacy have not been established.

3 points · 0 major

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Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointPhase 3 CATT1 enrollment completed, with 166 patients randomized.
• Moderate pointFDA Breakthrough Therapy designation granted for cadisegliatin as an adjunct to insulin in type 1 diabetes.
• Minor point. Forward-looking: it has not happened yet and may not happen.Topline results expected in mid 2027, according to the company.

Negative

• None.

Key Figures

Patients randomized: 166 patients Topline results timing: Mid 2027 Study duration: Six months +1 more

Patients randomized

166 patients

Phase 3 CATT1 study

Topline results timing

Mid 2027

Expected CATT1 study results

Study duration

Six months

CATT1 study

Dose regimens

800 mg once daily; 800 mg twice daily

Cadisegliatin study arms

Previous Clinical trial Reports

2 past events · Latest: Aug 07

Same Type 2 events

1. Aug 07

   CATT1 trial initiation

   24h Move

   -3.5%

   First participant randomized in the Phase 3 CATT1 study of cadisegliatin for T1D.

2. May 15

   CATT1 screening restart

   24h Move

   +5.2%

   Screening resumed after a protocol amendment shortened the CATT1 study duration to six months.

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

Key Terms

glucokinase activator, breakthrough therapy designation, hypoglycemia, placebo-controlled, +1 more

5 terms

glucokinase activator medical

"a potential first-in-class oral, liver-selective glucokinase activator"

A glucokinase activator is a drug that boosts the activity of glucokinase, an enzyme that helps the liver and pancreas sense and lower blood sugar. Think of it as turning up the sensitivity of the body’s sugar thermostat so insulin release and sugar storage respond more effectively; for investors, these drugs matter because they can become new diabetes treatments with sizable market potential while carrying typical development, safety and regulatory risks that affect a company’s value.

breakthrough therapy designation regulatory

"has received Breakthrough Therapy designation from the U.S. Food and Drug Administration"

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.

hypoglycemia medical

"reduce the risk of hypoglycemia"

Hypoglycemia is a condition where blood sugar falls too low to fuel the body and brain, causing symptoms like shakiness, confusion, sweating or fainting. Think of it as a car running low on gas: systems slow or fail until fuel is restored. Investors care because treatments, devices or drugs that cause or prevent hypoglycemia affect patient safety, regulatory approval, product labeling and market acceptance, which influence a company’s commercial prospects.

placebo-controlled technical

"a randomized, double-blind, placebo-controlled Phase 3 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.

hemoglobin a1c medical

"changes in hemoglobin A1c (HbA1c)"

A1c is a blood test that shows the average level of blood sugar over the previous two to three months, similar to a three-month average on a utility bill rather than a single daily reading. Investors care because A1c is a primary measure used to judge how well diabetes treatments and devices work, influences regulatory approvals, clinical trial success, reimbursement decisions, and the size of markets for related therapies and diagnostics.

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Milestone advances Phase 3 program toward topline results expected in mid 2027

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
John Fraunces
LifeSci Advisors, LLC
jfraunces@lifesciadvisors.com

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

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.

FAQ

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When does vTv Therapeutics expect results from the Phase 3 CATT1 study?

vTv Therapeutics expects topline results in mid 2027. Enrollment is complete, with 166 patients randomized in the study evaluating cadisegliatin as an adjunct to insulin for type 1 diabetes.

What is the primary endpoint of vTv Therapeutics’ CATT1 study?

The primary efficacy endpoint measures the incidence of level 2 and level 3 hypoglycemic events. The six-month study compares cadisegliatin with placebo and also evaluates blood sugar control and diabetic ketoacidosis incidence.