NCT07616206
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentvTv Therapeutics
~40 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Cadisegliatin 800 mg QDPlacebo
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the change in Time in Range (TIR)
Measured over last 2 weeks of the two 6-week treatment periods
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Study leadership
- Thomas Strack, MD · STUDY_DIRECTOR · vTv Therapeutics LLC
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Participants \>= 18 years of age
Fasting plasma C-peptide levels \<0.6 ng/ml
Average TIR \< 70% at the end of the screening period
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
Capable of participating in a 30-minute lasting exercise test
Exclusion
Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease.
Have been hospitalized for DKA within 3 months
Have uncontrolled hypothyroidism or hyperthyroidism
Have QTcF interval \> 450 msec for males or \> 470 msec for females
Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias
Have persistent, uncontrolled hypertension
Have clinically significant cardiovascular or cerebrovascular disease
Have proliferative retinopathy or maculopathy requiring acute treatment
Have a serious concomitant systemic disorder incliuding but not limited to HIV or active Hep B or Hep C
Diagnosed and/or treated for malignancy within 3 years
Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,
What this trial measures
- To assess the change in Time in Range (TIR)last 2 weeks of the two 6-week treatment periods
Time in Range (TIR) based on study CGM in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo