Data Readout

vTv's cadisegliatin heads toward Phase 3 T1D readout after a suspension

The CATT1 trial resumed after a 2024 suspension and now runs toward topline data in the second half of 2026, testing whether cadisegliatin cuts severe hypoglycemia beyond what a 2019 Phase 2 signal showed.

vTv Therapeutics expects topline Phase 3 data from its CATT1 trial of cadisegliatin in type 1 diabetes in the second half of 2026, testing whether the oral glucokinase activator cuts severe hypoglycemic events as an add-on to insulin.

By AppliedXLJuly 21, 2026Trial NCT06334133

Executive Summary

vTv Therapeutics is heading toward a Phase 3 readout for cadisegliatin in type 1 diabetes, with topline data expected in the back half of 2026 after the trial resumed from a suspension.
The trial tests whether an oral glucokinase activator added to insulin can reduce severe hypoglycemic events, the same endpoint a smaller predecessor trial in the same drug and disease already moved on a placebo comparison.
Cadisegliatin is the only glucokinase activator to reach Phase 3 in type 1 diabetes, giving the readout outsized weight for a mechanism that has otherwise been tested mainly in type 2 diabetes.
After an early suspension, the trial's enrollment target, primary endpoint, and completion timeline have held steady, and its readout is inside the sponsor's most recent public guidance window.

The trial and its stake

CATT1 (NCT06334133) is a randomized, double-blind, placebo-controlled Phase 3 study testing cadisegliatin, an oral, liver-selective glucokinase activator, as an add-on to insulin in adults with type 1 diabetes. The primary endpoint is the change in incidence of Level 2 or Level 3 hypoglycemia, the more severe categories of low blood sugar, measured against placebo. The trial enrolls roughly 150 patients who have had at least one Level 2 or Level 3 hypoglycemic event in the two months before screening and use insulin pumps or multiple daily injections. vTv holds Breakthrough Therapy designation for cadisegliatin in this indication, a designation the FDA grants for drugs addressing unmet need with early evidence of an outsized effect. NCT06334133+1

Probability of Success

Endpoint Met86%

Completes79%

Clinical Significance29%

Regulatory96%

A trial that had to restart

CATT1 began recruiting in June 2024, was suspended a month later, and did not resume screening until May 2025. vTv's own announcement of the restart tied the delay to a protocol amendment that shortened the trial from 12 to six months and added continuous glucose monitors for every participant to feed the primary endpoint. Paul Sekhri, the company's chairman, president and chief executive officer, said at the time: "We are thrilled that we have resumed our CATT1 Phase 3 trial and screened a subject under the amended protocol. 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". Since that restart, the enrollment target has held at 150 patients with no growth or contraction, and the primary completion date has stayed fixed at September 1, 2026. NCT06334133+1

The band it needs to clear

A completed Phase 1/2 trial of the same drug in the same disease, run by vTv and involving 115 patients, reported a 40% reduction in hypoglycemic episodes versus placebo, though the company's own summary of that trial noted no statistical testing on the primary HbA1c endpoint was disclosed. That is the result CATT1 exists to confirm at Phase 3 scale under a harder-edged endpoint definition (Level 2 or 3 events rather than any hypoglycemic episode) and with CGM-derived data across every arm. Because cadisegliatin is already approved nowhere and has no other same-drug Phase 3 precedent, this readout is the first test of whether the earlier signal holds up in a larger, longer-duration, prespecified pivotal design. NCT06334133

Where it sits in the field

Glucokinase activation has been tested across at least six industry trials, but the tier of comparators that share the same target and mechanism, including Suzhou Yabao Pharmaceutical's globalagliatin, Pfizer's PF-04991532, Eli Lilly's LY2599506, Merck's MK-0941 and AstraZeneca's AZD6370, were run in type 2 diabetes, not type 1. CATT1 is the only Phase 3 trial in the glucokinase-activator class targeting type 1 diabetes specifically. Within type 1 diabetes itself, the active competitive field is mechanistically distinct: Eli Lilly's Phase 3 baricitinib trial targets JAK1 to delay disease onset, and Sanofi's teplizumab targets CD3 to blunt immune destruction of insulin-producing cells, neither of which addresses hypoglycemia management in already-diagnosed patients on insulin. That leaves cadisegliatin without a direct Phase 3 rival on its specific mechanism and endpoint, so a durable hypoglycemia reduction here would be the first pivotal-stage evidence that liver-selective glucokinase activation, rather than immune modulation or CGM-driven insulin dosing alone, can move this outcome in type 1 diabetes. NCT06334133

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