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

NCT04083339 · tracked via the Priya Life Science UK tracker

Sponsor

Applied Therapeutics, Inc.

Phase

Phase 3

Started

2019-09-20

Last updated

2022-12-08

Condition(s) studied

Diabetic Cardiomyopathies

Investigational drug(s) / intervention(s)

AT-001Placebo

AT-001: AT-001 will be administered as 3 capsules twice daily, before breakfast and before dinner. At present AT001 is the sole name for the active substance. No INN/genetic name is available to date

Placebo: Matching placebo will be administered as 3 capsules twice daily, before breakfast and before dinner

Study 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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Type 2 Diabetes Mellitus * 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

Primary outcome measure(s)

Peak VO2 during cardio-pulmonary exercise test (CPET); — 15 months after randomization]
Changes in Peak VO2 during cardio-pulmonary exercise test (CPET) from baseline to approximately Month 15 (15-18 months). A CPET may be repeated at approximately Month 27 (27-30 months).

Trial sites (79)

Facility	City	Region
Westside Medical Associates of Los Angeles	Beverly Hills	California
University of California, San Diego (UCSD)	La Jolla	California
Clinical Trials Research	Lincoln	California
University of California - Irvine Medical Center	Orange	California
Metabolic Institute of America	Tarzana	California
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center	Torrance	California
ALL Medical Research, LLC	Cooper City	Florida
New Generation of Medical Research	Hialeah	Florida
Broward Research Center	Pembroke Pines	Florida
Progressive Medical Research	Port Orange	Florida
UnityPoint Health - Methodist Hospital	Peoria	Illinois
Brigham and Women's Hospital	Boston	Massachusetts
Universty of Mississippi Medical Center	Jackson	Mississippi
St. Louis Heart and Vascular Cardiology	St Louis	Missouri
Chear Center LLC	The Bronx	New York
Montefiore Medical Center	The Bronx	New York
Cleveland Clinic	Cleveland	Ohio
Remington Davis, Inc.	Columbus	Ohio
South Oklahoma Heart Research	Oklahoma City	Oklahoma
Mountain View Clinical Research - Greer	Greer	South Carolina
Mountain View Clinical Research	Greer	South Carolina
Holston Medical Group	Kingsport	Tennessee
Dallas Diabetes Research Center	Dallas	Texas
Southwest Family Medicine Associates	Dallas	Texas
University of Texas Southwestern	Dallas	Texas
Juno Research, LLC - Northwest Site	Houston	Texas
Juno Research, LLC - Southwest Houston Site	Houston	Texas
FMC Science	Lampasas	Texas
Prince Charles Hospital	Chermside	Queensland
CORE Research Group Pty. Ltd.	Milton	Queensland
AusTrials	Taringa	Queensland
University of Tasmania at Hobart	Hobart	Tasmania
Barwon Health-University Hospital Geelong	Geelong	Victoria
Austin Health	Heidelberg	Victoria
Baker Heart and Diabetes Institute	Melbourne	Victoria
C-Endo - Endocrinology Centre	Calgary	Alberta
BC Diabetes	Vancouver	British Columbia
LMC Diabetes & Endocrinology Ltd. - Brampton	Brampton	Ontario
LMC Diabetes & Endocrinology Ltd. - Thornhill	Concord	Ontario
LMC Diabetes & Endocrinology Ltd. - Etobicoke	Etobicoke	Ontario

+ 39 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04083339 on ClinicalTrials.gov ↗ ← All trials in the UK