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Type 1 Diabetes (T1D)Phase 2Hybrid CATT1NCT07616206

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems

A Phase 2 study testing Cadisegliatin 800 mg QD in people with Type 1 Diabetes (T1D), run by vTv Therapeutics at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes (T1D)
What is being tested?
Cadisegliatin 800 mg QD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Oct 2026to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 cannot join

  • 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
Show all 11Show fewer
  • 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,

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Meaghan Marnell contact

(336) 888-0435

clinicaltrials@vtvtherapeutics.com

United States1 site

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

    Bruce W Bode, MD

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
Cadisegliatin 800 mg QD, Placebo
Keywords
Hybrid Closed Loop
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cadisegliatin 800 mg QDDrug

    Also called TTP399

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

  • PlaceboDrug

    Placebo (insulin alone)

Study groups in NCT07616206
Study groupRoleWhat they receive
Cadisegliatin 800 mg QD, then PlaceboExperimentalIf 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
Receives: Drug: Cadisegliatin 800 mg QD; Drug: Placebo
Placebo, then Cadisegliatin 800 mg QDExperimentalIf 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
Receives: Drug: Cadisegliatin 800 mg QD; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the change in Time in Range (TIR)

    Time in Range (TIR) based on study CGM in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo

    Measured: last 2 weeks of the two 6-week treatment periods

Secondary outcomes (14)

  1. CGM-based metric for glycemic control

    Time In Tight Range (TITR)

    Measured: last 2 weeks of each treatment period

  2. CGM-based metric for glycemic control

    Time Above Range (TAR)

    Measured: last 2 weeks of each treatment period

  3. CGM-based metric for glycemic control

    Time Below Range (TBR)

    Measured: last 2 weeks of each treatment period

  4. CGM-based metric for glycemic control

    Glucose Management Indicator (GMI)

    Measured: last 2 weeks of each treatment period

  5. CGM-based metric for glycemic control

    Glucose variability (GV)

    Measured: last 2 weeks of each treatment period

  6. CGM-based metric for glycemic control

    Time in Range (TIR) > 70%

    Measured: last 2 weeks of each treatment period

  7. Change in glucose control after standardized mixed meal tolerance test (MMTT)

    Glucose Peak Plasma Concentration (Cmax) based on study CGM after standardized mixed meal tolerance test (MMTT)

    Measured: 12 weeks

  8. Change in glucose control after standardized mixed meal tolerance test (MMTT)

    Glucose Area under the plasma concentration versus time curve (AUC) based on study CGM after standardized mixed meal tolerance test (MMTT)

    Measured: 12 weeks

  9. To assess the change in Level 1, Level 2 , and Level 3 hypoglycemic incidence

    Number of events of Level 1 and Level 2 hypoglycemia as determined by CGM and Level 3 hypoglycemic events in participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo

    Measured: 12 weeks

  10. Assess incidence of Serious Adverse Events (SAEs)

    Number of Serious Adverse Events (SAEs)

    Measured: 14 weeks

  11. Assess incidence of Treatment Emergent Adverse Events (TEAEs)

    Number of treatment emergent adverse events (TEAEs)

    Measured: 14 weeks

  12. Assess incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuation

    Number of treatment emergent adverse events (TEAEs) leading to discontinuation of study drug

    Measured: 14 weeks

  13. Assess incidence of Adverse Events of Special Interest (AESIs)

    Number of adverse events of special interest (AESIs)

    Measured: 14 weeks

  14. Change from baseline in average daily total insulin dose

    Change from baseline in average daily total insulin dose in units (IU) based on manual entry in eDiary records from participants with T1D who are using hybrid closed loop systems on cadisegliatin vs placebo

    Measured: last week of the two 6-week treatment periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Double-blind placebo-controlled, cross-over
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07616206
Sponsor's protocol ID
TTP399-206
Acronym
Hybrid CATT1
Status last verified
Sep 2026
First submitted
15 May 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadisegliatin 800 mg QD in people with Type 1 Diabetes (T1D), run by vTv Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Meaghan Marnell ((336) 888-0435, clinicaltrials@vtvtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the change in Time in Range (TIR) (time frame: last 2 weeks of the two 6-week treatment periods). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07616206.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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