Archive pump, not study device: Mbbradford, public domain.
vTv Therapeutics says the first participant has been randomized in a pilot trial testing whether its investigational oral medicine cadisegliatin can help adults with type 1 diabetes who use hybrid closed-loop insulin delivery systems.
The October 27 company announcement marks the start of patient assignment in the Phase 2a Hybrid CATT1 study, not a report of treatment results. Cadisegliatin remains investigational, and its safety and effectiveness have not been established.
The study is designed to add the medicine to insulin, not replace insulin. It will evaluate glucose-control measures in approximately 40 adults already using hybrid closed-loop systems, according to the company and the ClinicalTrials.gov study record.
Testing an oral add-on alongside automated insulin delivery
Hybrid closed-loop systems combine a continuous glucose monitor, an insulin pump and software that adjusts insulin delivery. The company explains that these systems automate basal insulin adjustments but still require users to manage situations such as meals and exercise.
Cadisegliatin is a liver-selective glucokinase activator being developed as an oral add-on to insulin. vTv says laboratory and animal work supports investigating whether it can improve glucose control through effects on liver glucose uptake and glycogen storage. Those preclinical findings do not establish a clinical benefit in this trial’s participants.
The company said the new pilot will complement its separate Phase 3 CATT1 program. That later-stage study enrolled people using insulin pens or pumps in an open-loop manner, rather than hybrid closed-loop systems. Results in one group therefore would not automatically answer how the drug performs alongside an automated delivery system.
A crossover design, with glucose monitoring
Hybrid CATT1 is a randomized, double-blind, placebo-controlled crossover study. In that design, participants receive both study treatments in different periods, with the order determined by random assignment.
The registry describes an initial six-week period of cadisegliatin or placebo alongside insulin, a two-week washout and a second six-week period in which participants switch to the other study treatment. Its estimated enrollment is 40 adults.
vTv says the primary objective is to assess continuous-glucose-monitoring measures of glycemic control, including time in range, after six weeks of treatment. The study also includes standardized meal tests to examine glucose changes after eating.
The company expects the pilot to inform the design and conduct of future Phase 3 research in this population. It did not announce efficacy or safety results, a regulatory submission or an approval for use with hybrid closed-loop systems.
Registry status has not caught up with the company announcement
At the time of publication, the public ClinicalTrials.gov record still listed the study as “not yet recruiting,” while vTv’s new release said its first participant had been randomized. The reported enrollment milestone is therefore attributed to the company; the registry independently provides the study design but does not yet reflect that operational update.
The registry lists estimated primary and overall completion in June 2027. Estimates and trial plans may change as recruitment and follow-up proceed.
For patients and clinicians, the immediate development is an early-stage test of an additional treatment approach alongside insulin technology already in use. Whether cadisegliatin improves glucose control or reduces hypoglycemia in that setting remains a question for the trial, not an established outcome of today’s announcement.
JBizNews Desk | New York
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