Phase 2: testing Cadisegliatin 800 mg QD for Type 1 Diabetes (T1D)
TTP399-206 is a Phase 2a multicenter double blind cross over randomly assigned 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 randomly assigned to either receive blinded cadisegliatin 800 mg QD as an added on top of your current treatment therapy to their insulin treatment or dummy treatment (placebo) QD along with their insulin treatment.
Official registry: https://clinicaltrials.gov/study/NCT07616206 · vTv Therapeutics · enrollment listed as 40
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Cadisegliatin 800 mg QD, or Placebo. The registry lists allocation as randomized. TTP399-206 is a Phase 2a multicenter double blind cross over randomly assigned study of cadisegliatin in participants with T1D using hybrid closed loop systems to manage their diabetes.
They plan to enroll about 40 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Hybrid CATT1: Hybrid Closed Loop Insulin Pumps With Cadisegliatin as Adjunctive Treatment in Patients With Type 1 Diabetes A Phase 2a Double Blind Randomized Cross-Over Study
Interventions: Cadisegliatin 800 mg QD, Placebo
Primary outcome (registry wording): To assess the change in Time in Range (TIR)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
Who the registry excludes
- 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
Public study contact (from the registry)
Meaghan Marnell
clinicaltrials@vtvtherapeutics.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
6 listed- Paradigm Clinical Research -Modesto — Modesto, California (recruiting)
- Paradigm Clinical Research Centers, LLC — San Diego, California (recruiting)
- Barbara Davis Center for Diabetes — Aurora, Colorado (recruiting)
- Atlanta Diabetes Associates — Atlanta, Georgia (recruiting)
- UNC Eastowne Medical Office Building — Chapel Hill, North Carolina (recruiting)
- Texas Diabetes & Endocrinology, P.A. — Austin, Texas (recruiting)
FAQ about this NCT record
Is NCT07616206 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07616206?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07616206?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary