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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Diabetic Cardiomyopathies

In brief

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.

Key facts

Study ID

NCT04083339

Run by

Applied Therapeutics, Inc.

People needed

675

Starts

2019-09-20

Expected to finish

2025-12-01

Last updated by the study team

2022-12-08

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 Diabetes Mellitus
• Diabetic cardiomyopathy
• Peak VO2 < 75% of predicted normal value based on age and gender

You may not qualify if…

• 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

Where it is running

• University of California, San Diego (UCSD) — La Jolla, California, United States
• Clinical Trials Research — Lincoln, California, United States
• University of California - Irvine Medical Center — Orange, California, United States
• Metabolic Institute of America — Tarzana, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center — Torrance, California, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• New Generation of Medical Research — Hialeah, Florida, United States
• Broward Research Center — Pembroke Pines, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• UnityPoint Health - Methodist Hospital — Peoria, Illinois, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Universty of Mississippi Medical Center — Jackson, Mississippi, United States
• St. Louis Heart and Vascular Cardiology — St Louis, Missouri, United States
• Chear Center LLC — The Bronx, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Remington Davis, Inc. — Columbus, Ohio, United States
• South Oklahoma Heart Research — Oklahoma City, Oklahoma, United States
• Mountain View Clinical Research - Greer — Greer, South Carolina, United States
• Mountain View Clinical Research — Greer, South Carolina, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Dallas Diabetes Research Center — Dallas, Texas, United States
• Southwest Family Medicine Associates — Dallas, Texas, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Westside Medical Associates of Los Angeles — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.