vTv Therapeutics
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.
TTP399-206 is a 20 week, Phase 2a trial designed to evaluate efficacy and safety of cadisegliatin in participants with T1D who are using hybrid closed loop (HCL) systems to manage their condition to gather preliminary data to understand how cadisegliatin performs in an HCL setting.
Key Inclusion Criteria: * Participants \>= 18 years of age * Fasting C-peptide levels \<0.6 ng/ml * Average TIR \< 70% recorded on their personal CGM data collected over the past 7 days prior to Visit 1 * Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration * Willing to wear a study provided CGM for study duration * Total bilirubin ≤2×ULN, ALT and AST ≤3×ULN Key Exclusion Criteria: * Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes…
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator, adjunctive therapy to insulin
Placebo (insulin alone)
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