Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems

Study acronym: Hybrid CATT1
StatusNot Yet Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 32 days later Apr 2027 → Jun 2027
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Record History

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  1. Notable Start date: Jul 2026 to Oct 2026 Show 4 more changesShow less
    • Primary completion pushed from Apr 2027 to Jun 2027
    • Study completion date: May 2027 to Jun 2027
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: 17 to 14
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
5,101 trials monitored
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888 trials monitored
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TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manage their diabetes. Participants using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participants will cross-over to the treatment that they did not receive in the first treatment period.
Trial Details
NCT Number NCT07616206
Lead Sponsor vTv Therapeutics
Conditions
(from sponsor)
Type 1 Diabetes (T1D)
Related terms Diabetes Mellitus, Type 1
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov