Recruiting
Phase 2

Cadisegliatin

Sponsor:

vTv Therapeutics

Code:

NCT07616206

Conditions

Type 1 Diabetes (T1D)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cadisegliatin 800 mg QD

Placebo

Study Details

Brief summary:

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.

Conditions

Type 1 Diabetes (T1D)

Study ID

NCT07616206

Start date

Sep 29, 2026

Status verified date

Nov, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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,

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cadisegliatin 800 mg QD, then Placebo

If a participant is randomized to receive cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment in 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 participant will cross-over to the placebo QD along with their insulin treatment

experimental: Placebo, then Cadisegliatin 800 mg QD

If a participant is randomized to receive placebo QD along with their insulin treatment in 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 participant will cross-over to the cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment

Interventions

Cadisegliatin 800 mg QD

Cadisegliatin is an orally bioavailable small-molecule glucokinase activator, adjunctive therapy to insulin

Placebo

Placebo (insulin alone)

Primary outcome measure

  • To assess the change in Time in Range (TIR) [ Time Frame: last 2 weeks of the two 6-week treatment periods ]

Central Contacts and Locations

Central contacts

Meaghan Marnell

(336) 888-0435clinicaltrials@vtvtherapeutics.com

Locations

Paradigm Clinical Research -Modesto

Recruiting

Modesto, California, United States, 95355

Principal Investigator:

Gopika Gangupantula, MD

Paradigm Clinical Research Centers, LLC

Recruiting

San Diego, California, United States, 92108

Principal Investigator:

Schafer Boeder, MD

Barbara Davis Center for Diabetes

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Halis Kaan Akturk, MD

Atlanta Diabetes Associates

Recruiting

Atlanta, Georgia, United States, 30318

Principal Investigator:

Bruce W Bode, MD

UNC Eastowne Medical Office Building

Recruiting

Chapel Hill, North Carolina, United States, 27514

Principal Investigator:

Klara Klein, MD, PhD

Texas Diabetes & Endocrinology, P.A.

Recruiting

Austin, Texas, United States, 78731

Principal Investigator:

Thomas Blevins, MD

More Information

Sponsor

vTv Therapeutics

Last update posted

Nov 10, 2026

Last verified

Nov, 2026

Keywords

  • Hybrid Closed Loop

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by vTv Therapeutics on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.