vTv Therapeutics Announces Reinitiation of Screening in CATT1 Phase 3 Trial Evaluating Potential First-in-Class Liver-Selective Glucokinase Activator Cadisegliatin for Type 1 Diabetes
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Insights
vTv's Phase 3 trial resumption with shortened timeline accelerates development of potentially groundbreaking Type 1 diabetes therapy with FDA Breakthrough designation.
vTv Therapeutics has hit a significant clinical milestone with the reinitiation of screening in their CATT1 Phase 3 trial for cadisegliatin in Type 1 diabetes (T1D). The strategic protocol amendment reducing trial duration from 12 to 6 months represents a substantial acceleration of their clinical timeline without compromising the primary endpoint evaluation.
Cadisegliatin's mechanism as a liver-selective glucokinase activator is particularly promising for T1D management. This oral medication targets the liver specifically, which could potentially minimize off-target effects seen with previous glucokinase activators. The FDA Breakthrough Therapy designation underscores the significant unmet need and the drug's potential to provide substantial improvement over existing therapies.
The primary endpoint focusing on hypoglycemic events is clinically meaningful and directly addresses one of the most dangerous and limiting aspects of current T1D management. By providing continuous glucose monitors to all participants, the company has enhanced endpoint measurement precision while potentially improving subject retention.
With approximately 150 patients across 20-25 US sites, the trial is appropriately sized for a Phase 3 study in this indication. If successful, cadisegliatin could represent a paradigm shift in T1D treatment as an adjunctive oral therapy to insulin, potentially reducing insulin requirements and dangerous blood sugar fluctuations that plague T1D patients.
The expected topline data in 2H 2026 positions this as a medium-term catalyst for vTv's pipeline, with subsequent pivotal studies and NDA submission timelines now accelerated due to the protocol amendment.
Topline CATT1 Phase 3 data is expected in 2H 2026
Protocol amendment shortens trial duration from 12 to 6 months, expediting time to topline data
HIGH POINT, N.C., May 15, 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 that screening has been reinitiated in the Company’s CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive treatment of 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 Food and Drug Administration (FDA).
“We are thrilled that we have resumed our CATT1 Phase 3 trial and screened a subject under the amended protocol,” said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. “The amendment to the protocol will help expedite time to both topline data and the initiation of required larger pivotal studies moving us one step closer to the future New Drug Application (NDA) submission. We look forward to reporting topline Phase 3 data from CATT1 in the second half of 2026.”
vTv Therapeutics reinitiated the CATT1 study and has screened a subject under a recently submitted protocol amendment that reduced the overall duration of the trial from 12 to 6 months, which will expedite time to topline data with no impact on the key study endpoints. Under the protocol amendment, continuous glucose monitors (CGM) will now be provided to all participants to inform the primary study endpoint, which is the number of level 2 and level 3 hypoglycemic events.
CATT1 is a randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of cadisegliatin over 6 months in adults 18 years or older diagnosed with T1D. The trial is expected to enroll approximately 150 patients at 20-25 sites in the U.S. Two doses of orally administered cadisegliatin versus placebo will be assessed in patients currently being treated with multiple daily insulin injections and continuous subcutaneous insulin infusion who use a provided continuous glucose monitor. The primary efficacy endpoint of the study will compare the incidence of level 2 and level 3 hypoglycemic events between cadisegliatin-treated subjects and those in the placebo group.
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 Inc. is a late-stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv’s clinical pipeline is led by cadisegliatin, a potential adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications including type 2 diabetes and other chronic conditions.
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