vTv Therapeutics Announces First Study Participant Randomized in CATT1 Phase 3 Trial of Cadisegliatin in Type 1 Diabetes
Rhea-AI Summary
vTv Therapeutics (Nasdaq: VTVT) has announced the randomization of its first participant in the CATT1 Phase 3 trial for cadisegliatin, a potential first-in-class oral treatment for Type 1 Diabetes (T1D). The trial will evaluate cadisegliatin as an adjunctive treatment to insulin in adults with T1D.
The study will enroll approximately 150 participants across 25 U.S. sites, testing two dose regimens (800 mg once or twice daily) against placebo. The drug, which has received FDA Breakthrough Therapy designation, has shown good tolerability in over 500 subjects. The trial's primary endpoint focuses on hypoglycemic events, with topline results expected in second half of 2026.
Positive
- Received FDA Breakthrough Therapy designation for cadisegliatin
- Well-tolerated in over 500 subjects with up to six months of treatment
- Addresses significant unmet need as potentially first FDA-approved oral adjunct therapy to insulin for T1D
- Targets large market of 1.6 million Americans living with T1D
Negative
- Extended timeline with topline results not expected until second half of 2026
- Requires relatively large Phase 3 trial across 25 sites
Insights
vTv's advancement of cadisegliatin to Phase 3 trials marks a significant milestone for a potential first oral adjunct therapy for Type 1 diabetes.
vTv Therapeutics has reached a critical milestone with the randomization of the first participant in their Phase 3 CATT1 trial for cadisegliatin. This liver-selective glucokinase activator represents a potential first-in-class oral therapy for Type 1 diabetes (T1D), an area with significant unmet need despite advances in glucose monitoring devices.
The FDA's Breakthrough Therapy designation for cadisegliatin underscores its promising clinical profile. The compound has demonstrated favorable tolerability in over 500 subjects with treatment durations up to six months. What makes this development particularly noteworthy is that there is currently no FDA-approved oral adjunct therapy to insulin for T1D management.
The Phase 3 CATT1 trial design is robust: randomized, double-blind, and placebo-controlled with approximately 150 participants across up to 25 U.S. sites. The study will evaluate two dosing regimens (800 mg once or twice daily) over a six-month treatment period. The primary endpoint focuses on hypoglycemic events, while secondary endpoints include HbA1c reduction, time in target glycemic range, and incidence of diabetic ketoacidosis.
Significantly, the mechanism of glucokinase activation shows potential to improve glycemic control while possibly reducing risks of both hypoglycemia and ketosis - addressing the fundamental "tightrope" challenge in T1D management. Topline results expected in H2 2026 will be crucial in determining whether cadisegliatin can deliver on its promise to transform T1D care for the 1.6 million Americans living with this condition.
Topline results from CATT1 Phase 3 trial expected in second half of 2026
HIGH POINT, N.C., Aug. 07, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced the first study participant has been randomized in the Company’s CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive treatment to insulin in adults with type 1 diabetes (T1D). Cadisegliatin is a potential first-in-class, oral, liver-selective glucokinase activator for T1D that has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and has been well-tolerated in over 500 subjects to date with up to six months of treatment.
Despite major advances made in medical devices used to help manage blood glucose levels in people living with T1D, there have been few therapeutic advances. To date, there has not been any FDA-approved oral adjunct therapy to insulin to treat T1D. “Randomizing the first participant in CATT1 represents another key milestone for vTv’s development of cadisegliatin as a potential therapy to improve glycemic control for the nearly 1.6 million Americans living with T1D,” said Dr. Thomas Strack, Chief Medical Officer of vTv Therapeutics. “We look forward to reporting topline Phase 3 data from CATT1 in the second half of 2026.”
The Phase 3 CATT1 trial (NCT06334133) is being conducted at up to 25 sites in the U.S. Recruitment is ongoing, and the trial is expected to enroll approximately 150 participants. The trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of cadisegliatin over six months in adults 18 years or older diagnosed with T1D. Two different dose regimens (800 mg once or twice daily) of orally administered cadisegliatin versus placebo will be assessed in participants currently being treated with multiple daily insulin injections or continuous subcutaneous insulin infusion. Per the protocol, continuous glucose monitors (CGM) will now be provided to all participants to inform the primary study endpoint, which is the incidence of level 2 and 3 hypoglycemic events in cadisegliatin-treated participants compared to those in the placebo group (insulin alone). Select secondary endpoints include reduction in hemoglobin A1C (HbA1c), time in target range of glycemic control, and incidence of diabetic ketoacidosis.
“Although there have been major advances in medical devices for the treatment of type 1 diabetes, there is a huge unmet need to identify therapies that improve glycemia without increasing the risk of ketosis or hypoglycemia,” said diabetes expert, Klara Klein, MD, PhD, who is Assistant Professor of Medicine at the University of North Carolina at Chapel Hill. “People with type 1 diabetes continue to walk a tightrope between hyper- and hypoglycemia. There's real potential for glucokinase activators not only to improve glycemia overall but to do so while providing some protection against hypoglycemia and, potentially, diabetic ketoacidosis, which could ease some of the mental burden of type 1 diabetes care.”
About Cadisegliatin
Cadisegliatin (TTP399) is a novel, oral small molecule, liver-selective glucokinase activator being investigated 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 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 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.
Forward-Looking Statements
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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 primary endpoint of vTv Therapeutics' CATT1 Phase 3 trial for cadisegliatin?
How many participants will be enrolled in VTVT's CATT1 Phase 3 trial?
What dosing regimens are being tested in the CATT1 Phase 3 trial?
When will vTv Therapeutics (VTVT) report topline results from the CATT1 trial?
What makes cadisegliatin unique in the Type 1 Diabetes treatment landscape?
