Cadisegliatin for Type 1 Diabetes

(CATT1 Trial)

Recruiting at 33 trial locations

Overseen By Thomas Strack

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: vTv Therapeutics

Must be taking: Insulin

Must not be taking: SGLT-2 inhibitors, GLP-1 agonists

Disqualifiers: T2DM, Eating disorders, Malignancy, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a new treatment, cadisegliatin, works alongside insulin for people with Type 1 Diabetes. The goal is to determine if cadisegliatin can manage blood sugar levels more effectively than insulin alone. Participants will be divided into groups, with some receiving cadisegliatin and others a placebo (a pill with no medicine). The trial seeks individuals who have had Type 1 Diabetes for at least 5 years and have experienced low blood sugar episodes requiring assistance in the past two months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

You may need to stop certain medications before joining this trial. Specifically, you cannot have used non-insulin diabetes medications or weight loss drugs within 30 days before the screening. The trial does not specify other medications, so check with the study team for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that cadisegliatin, a treatment under study for type 1 diabetes, appears safe. In previous studies, patients using cadisegliatin reported no major safety issues. The FDA approved further testing of this treatment, indicating trust in its safety.

Although cadisegliatin is not yet approved for type 1 diabetes, ongoing trials aim to ensure its safety for users. So far, the available data reports no major side effects. This is encouraging for prospective participants, as it suggests the treatment has been safe for most in earlier research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Cadisegliatin is unique because it offers a potential new approach for managing Type 1 diabetes. Unlike standard treatments that primarily focus on insulin replacement, Cadisegliatin targets glucose regulation through a novel mechanism. Researchers are excited about its ability to offer more precise blood sugar control, which could reduce the need for insulin adjustments and enhance overall diabetes management. With dosing options of once or twice daily, Cadisegliatin also provides flexibility that could fit better into patients' lifestyles.

What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?

Research has shown that cadisegliatin is being studied to help people with Type 1 Diabetes manage blood sugar levels more effectively. In this trial, participants will receive either cadisegliatin at varying dosages or a placebo. Cadisegliatin aids the body in using sugar more efficiently. So far, participants have tolerated it well, and it has not increased the risk of diabetic ketoacidosis, a serious diabetes complication. Nearly 600 people have tried cadisegliatin, and it appears promising in reducing serious low blood sugar events. These findings suggest cadisegliatin could complement insulin therapy in managing Type 1 Diabetes. ^{2 3 4 6 7}

Who Is on the Research Team?

Thomas Strack, MD

Principal Investigator

vTv Therapeutics

Are You a Good Fit for This Trial?

Adults over 18 with Type 1 Diabetes for at least 5 years, who've had a serious low blood sugar event recently. They must have an HbA1c level below 9.5% and be on continuous or multiple daily insulin injections without changing their treatment method throughout the study.

Inclusion Criteria

I've had a serious low blood sugar event in the last 2 months.

I have been using a CGM device for at least 3 months.

I have had Type 1 Diabetes for at least 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Device Training and Insulin Adjustment

Participants undergo device training and insulin adjustment

4 weeks

Baseline

Participants enter a baseline period before treatment

4 weeks

Treatment

Participants receive cadisegliatin or placebo for 26 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cadisegliatin

Trial Overview The trial is testing Cadisegliatin as an extra treatment alongside insulin for Type 1 Diabetes. Participants will either receive Cadisegliatin twice daily (BID), once daily (QD), or a placebo to compare effects.

How Is the Trial Designed?

Group I: Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg QD Experimental Treatment 1 Intervention

The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.

Group II: Cadisegliatin: 26 Week Double Blind Treatment Period - 800 mg BID Experimental Treatment 1 Intervention

The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.

Group III: Placebo: 26 Week Double Blind Treatment Period Placebo Group 1 Intervention

The main study uses a randomized, double-blind, placebo-controlled design with parallel assignment among 3 treatment arms. The trial begins with a screening period of up to 14 days, followed by a 28-day device training and insulin adjustment period leading into a 28-day baseline period before entering the 26-week treatment period. Insulin is adjunctive therapy.

Who Is Running the Clinical Trial?

vTv Therapeutics

Lead Sponsor

Trials

14

Recruited

2,700+

Citations

1. ir.vtvtherapeutics.com ir.vtvtherapeutics.com/news-releases/news-release-details/vtv-therapeutics-announces-first-study-participant-randomized

Press Release - Investor Overview - vTv Therapeutics Inc. vTv Therapeutics Announces First Study Participant Randomized in CATT1 Phase 3 Trial of Cadisegliatin in Type 1 Diabetes | vTv Therapeutics Inc.

2. breakthrought1d.org breakthrought1d.org/news-and-updates/the-inside-scoop-on-the-catt1-clinical-trial/

The inside scoop on the CATT1 clinical trial Nearly 600 participants have received cadisegliatin so far—it's been well-tolerated and hasn't increased the risk of diabetic ketoacidosis (DKA) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06334133

Study Details | NCT06334133 | Cadisegliatin as Adjunctive ... A 26-week, Phase 3 trial designed to measure the relative efficacy of adjunctive treatment with cadisegliatin to reduce the incidence of Level 2 or Level 3 ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/fda-vtv-cadisegliatin-programme/

FDA removes hold on vTv's cadisegliatin clinical programme The FDA has removed the clinical hold on vTv Therapeutics' cadisegliatin clinical programme, including the Phase III CATT1 trial for T1D.

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/VTVT-Q/pressreleases/35738371/vtv-therapeutics-promising-phase-3-study-on-cadisegliatin-for-type-1-diabetes/

vTv Therapeutics' Promising Phase 3 Study on ... ' The study aims to evaluate the efficacy of cadisegliatin, a glucokinase activator, as an adjunctive therapy to insulin in patients with Type 1 ...

6. ir.vtvtherapeutics.com ir.vtvtherapeutics.com/news-releases/news-release-details/vtv-therapeutics-announces-fda-has-lifted-clinical-hold

vTv Therapeutics Announces FDA has Lifted Clinical Hold on ... Cadisegliatin has the potential to be the first oral adjunct therapy for type 1 diabetes ... safety data. By shortening the trial from 12 to 6 months, the ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=8608debe-3005-49a5-93f8-f3899aa4cf66

cadisegliatin (TTP399) / vTv Therapeutics Dorzagliatin enhances GLP-1 secretion by restoring the function of intestinal L-cells (EASD 2025) - "Our study reveals the unique ability of dorzagliatin to ...