Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of AT-001 in adult patients (N=675) with Diabetic Cardiomyopathy at high risk of progression to overt heart failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Applied Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Type 2 Diabetes Mellitus

• Echocardiographic demonstration of diabetic cardiomyopathy

• Peak VO2 < 75% of predicted normal value based on age and gender

Exclusion Criteria:

• Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure

• Prior echocardiogrphic measurement of ejection fraction (EF) < 40%

• Prior acute coronary syndrome (ACS), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), coronary artery disease (CAD) or stroke

• Severe or moderate cardiac valve disease requiring intervention

• Clinically significant arrhythmia

• Prior diagnosis of congenital, infective, toxic, infiltrative, post-partum, or hypertrophic cardiomyopathy

• Blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at screening

• HbA1c >8.5% at screening

• Severe disease that would impact the performance of a cardio-pulmonary exercise test