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

NCT07616206 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: TTP399-206
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Keywords

Hybrid Closed Loop

Outcome Measures

Primary Outcomes (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

  last 2 weeks of the two 6-week treatment periods

Secondary Outcomes (14)

• CGM-based metric for glycemic control

  last 2 weeks of each treatment period

• CGM-based metric for glycemic control

  last 2 weeks of each treatment period

• CGM-based metric for glycemic control

  last 2 weeks of each treatment period

• CGM-based metric for glycemic control

  last 2 weeks of each treatment period

• CGM-based metric for glycemic control

  last 2 weeks of each treatment period

Study Arms (2)

Cadisegliatin 800 mg QD, then Placebo

EXPERIMENTAL

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

Drug: Cadisegliatin 800 mg QD; Drug: Placebo

Placebo, then Cadisegliatin 800 mg QD

EXPERIMENTAL

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

Drug: Cadisegliatin 800 mg QD; Drug: Placebo

Interventions

Cadisegliatin 800 mg QD DRUG

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

Also known as: TTP399

Cadisegliatin 800 mg QD, then Placebo; Placebo, then Cadisegliatin 800 mg QD

Placebo DRUG

Placebo (insulin alone)

Cadisegliatin 800 mg QD, then Placebo; Placebo, then Cadisegliatin 800 mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• vTv Therapeutics: lead

Study Sites (1)

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

TTP399

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maria Alba, MD

  vTv Therapeutics LLC

  STUDY DIRECTOR

Central Study Contacts

Meaghan Marnell

CONTACT

(336) 888-0435; clinicaltrials@vtvtherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind placebo-controlled, cross-over

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 1, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

US (1)