NCT07616206 · vTv Therapeutics
Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems
(Hybrid CATT1)
What this study is about
TTP399-206 is a Phase 2a conducted at multiple hospitals double blind cross over randomly assigned study of cadisegliatin in participants with T1D using hybrid closed loop systems to manage their diabetes.
View original scientific description
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.
Interventions
DRUG
Cadisegliatin 800 mg QD
Cadisegliatin is an orally bioavailable small-molecule glucokinase activator, adjunctive therapy to insulin
DRUG
Placebo
Placebo (insulin alone)
Primary outcome measures
To assess the change in Time in Range (TIR)
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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 including but not limited to HIV or active Hep B or Hep C
- Have been 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,
Where
- Modesto, California
- San Diego, California
- Aurora, Colorado
- Atlanta, Georgia
- Chapel Hill, North Carolina
- Austin, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2026 · Source of record for eligibility and locations