AT-001 for Diabetic Cardiomyopathy

Recruiting in Palo Alto (17 mi)

+79 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Applied Therapeutics, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called AT-001 to see if it can help adults with a heart condition related to diabetes. The goal is to improve their heart function or prevent it from getting worse, especially for those at high risk of severe heart failure.

Eligibility Criteria

This trial is for adults with Diabetic Cardiomyopathy who are at high risk of developing heart failure. Participants must have Type 2 Diabetes and reduced exercise capacity (Peak VO2 < 75% of normal). They can't join if they've had severe heart issues, uncontrolled blood pressure, or a history of significant cardiac events.

Inclusion Criteria

I have Type 2 Diabetes.

My exercise capacity is less than 75% of what's expected for my age and gender.

I have heart problems related to diabetes.

Exclusion Criteria

I need treatment for a serious heart valve problem.

I have a serious irregular heartbeat.

I have been diagnosed with a specific heart muscle condition before.

I have had heart issues like a heart attack, bypass surgery, stent placement, or stroke.

I have a severe condition that affects my ability to do a cardio-pulmonary exercise test.

I have been diagnosed with or show signs of advanced heart failure.

Participant Groups

The study tests the safety and effectiveness of AT-001 against a placebo in managing Diabetic Cardiomyopathy to prevent worsening into overt heart failure. It's conducted across multiple centers where participants are randomly assigned to either the drug or placebo group.

3Treatment groups

Experimental Treatment

Placebo Group

Group I: AT-001 Low DoseExperimental Treatment1 Intervention

The total daily doses will be of 2g. The dose selection and the frequency of dosing was based on the results of the phase 1/2 study demonstrating that 2g/day of AT-001 is capable of producing a sufficient inhibition of the production of sorbitol (a pharmacodynamic biomarker of biological activity).

Group II: AT-001 High doseExperimental Treatment1 Intervention

The total daily doses will be of 3g. The dose selection and the frequency of dosing was based on the results of the phase 1/2 study demonstrating that 3g/day of AT-001 is capable of producing the maximum inhibition of the production of sorbitol (a pharmacodynamic biomarker of biological activity).

Group III: Placebo ComparatorPlacebo Group1 Intervention

Placebo capsules will be used as comparator