Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy
NCT ID: NCT04083339
Last Updated: 2022-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
675 participants
INTERVENTIONAL
2019-09-20
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AT-001 High dose
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).
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
AT-001 Low Dose
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).
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 Comparator
Placebo capsules will be used as comparator
Placebo
Matching placebo will be administered as 3 capsules twice daily, before breakfast and before dinner
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Diabetic cardiomyopathy
* Peak VO2 \< 75% of predicted normal value based on age and gender
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Applied Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James L Januzzi, MD
Role: STUDY_CHAIR
Harvard Medical School (HMS and HSDM)
Locations
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Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
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
Juno Research, LLC - Northwest Site
Houston, Texas, United States
Juno Research, LLC - Southwest Houston Site
Houston, Texas, United States
FMC Science
Lampasas, Texas, United States
Prince Charles Hospital
Chermside, Queensland, Australia
CORE Research Group Pty. Ltd.
Milton, Queensland, Australia
AusTrials
Taringa, Queensland, Australia
University of Tasmania at Hobart
Hobart, Tasmania, Australia
Barwon Health-University Hospital Geelong
Geelong, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
C-Endo - Endocrinology Centre
Calgary, Alberta, Canada
BC Diabetes
Vancouver, British Columbia, Canada
LMC Diabetes & Endocrinology Ltd. - Brampton
Brampton, Ontario, Canada
LMC Diabetes & Endocrinology Ltd. - Thornhill
Concord, Ontario, Canada
LMC Diabetes & Endocrinology Ltd. - Etobicoke
Etobicoke, Ontario, Canada
Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University
London, Ontario, Canada
LMC Diabetes & Endocrinology Ltd. - Toronto
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie De Quebec
Québec, Quebec, Canada
Edumed s.r.o.
Jaroměř, , Czechia
Nemocnice Pardubickeho kraje, a.s., Nemocnice Pardubice
Pardubice, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Hôpital Jean-Verdier - AP-HP; Service Endocrinologie Diabétologie Nutrition
Bondy, , France
CHU Henri Mondor
Créteil, , France
CHU de Nantes, Clinique d'Endocrinologie
Nantes, , France
Centre Hospitalier de Valenciennes
Valenciennes, , France
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), Brandenburg, Germany
Herz-und Diabeteszentrum NRW Universitaetsklinik der Ruhr-Universitaet Bochum
Bad Oeynhausen, North Rhine-Westphalia, Germany
Cardiologicum Pirna und Dresden
Dresden, Saxony, Germany
Klinische Forschung Berlin GbR
Berlin, , Germany
ZKS - Zentrum Klinische Studien Sudbrandenburg GmbH
Elsterwerda, , Germany
Erik Yee Mun George Fung
Shatin, , Hong Kong
Prince of Wales Hospital; Chinese University of Hong Kong; Dept of Medicine and Therapeutics
Shatin, , Hong Kong
Centrum Chorob Serca w USK
Wroclaw, Borowska, Poland
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny
Bialystok, , Poland
Topolowa MEDICENTER Mrózek & wspólnicy sp.j.
Krakow, , Poland
Centrum Twojego Zdrowia
Krakow, , Poland
ETG Lodz
Lodz, , Poland
Praktyka Lekarska Ewa Krzyzagorska
Poznan, , Poland
Prywatny Gabinet Lekarski Centrum Medyczne Diabetika
Radom, , Poland
Centrum Medyczne Medyk Stanislaw Mazur Sp. z o.o. SK
Rzeszów, , Poland
4 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny ZOZ we Wroclawiu
Wroclaw, , Poland
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Abente y Lago (Complejo Universitario de la Coruña)
A Coruña, , Spain
Hospital de la Santa Creu i Sant Pau Barcelona
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Ninewells Hospital & Medical School
Dundee, , United Kingdom
CPS Research
Glasgow, , United Kingdom
Glenfield hospital
Leicester, , United Kingdom
Barts and The London School of Medicine & Dentistry
London, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Countries
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References
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Blumer V, Januzzi JL Jr, Liu Y, Butler J, Ezekowitz JA, Perfetti R, Rosenstock J, Del Prato S, Tang WHW, Urbinati A, Zannad F, Lewis GD, Solomon SD, Hedge S, Ibrahim NE, Lam CSP. Sex Differences in Diabetic Cardiomyopathy and Treatment Response to AT-001: Insights From the ARISE-HF Study. JACC Heart Fail. 2025 May 8:102433. doi: 10.1016/j.jchf.2025.02.015. Online ahead of print.
Siddiqi TJ, Liu Y, Zannad F, Tang WHW, Solomon S, Rosenstock J, Perfetti R, Marwick TH, Lewis GD, Lam CSP, Ibrahim NE, Ezekowitz J, Del Prato S, Butler J, Januzzi JL. Health status in stage B heart failure from diabetic cardiomyopathy baseline results from ARISE-HF. J Diabetes Complications. 2025 Jul;39(7):109059. doi: 10.1016/j.jdiacomp.2025.109059. Epub 2025 Apr 25.
Tang WHW, Liu Y, Butler J, Del Prato S, Ezekowitz JA, Ibrahim NE, Lam CSP, Marwick TH, Perfetti R, Rosenstock J, Solomon SD, Zannad F, Januzzi JL, Lewis GD. Impaired Exercise Capacity in High-Risk Diabetic Cardiomyopathy: The ARISE-HF Cardiopulmonary Exercise Testing Subanalysis. Circ Heart Fail. 2025 Mar;18(3):e012200. doi: 10.1161/CIRCHEARTFAILURE.124.012200. Epub 2025 Jan 30.
Marwick TH, Lam C, Liu Y, Del Prato S, Rosenstock J, Butler J, Ezekowitz J, Ibrahim NE, Tang WHW, Zannad F, Perfetti R, Januzzi JL. Echocardiographic phenotypes of diabetic myocardial disorder: evolution over 15 months follow-up in the ARISE-HF trial. Cardiovasc Diabetol. 2025 Jan 13;24(1):16. doi: 10.1186/s12933-024-02554-y.
Gouda P, Liu Y, Butler J, Del Prato S, Ibrahim NE, Lam CSP, Marwick T, Rosenstock J, Tang W, Zannad F, Januzzi J, Ezekowitz J. Relationship between NT-proBNP, echocardiographic abnormalities and functional status in patients with subclinical siabetic cardiomyopathy. Cardiovasc Diabetol. 2024 Aug 2;23(1):281. doi: 10.1186/s12933-024-02378-w.
Lopez J, Liu Y, Butler J, Del Prato S, Ezekowitz JA, Lam CSP, Marwick TH, Rosenstock J, Tang WHW, Perfetti R, Urbinati A, Zannad F, Januzzi JL Jr, Ibrahim NE. Racial Differences in Diabetic Cardiomyopathy: The ARISE-HF Trial. J Am Coll Cardiol. 2024 Jul 16;84(3):233-243. doi: 10.1016/j.jacc.2024.04.053.
Januzzi JL Jr, Butler J, Del Prato S, Ezekowitz JA, Ibrahim NE, Lam CSP, Lewis GD, Marwick TH, Perfetti R, Rosenstock J, Solomon SD, Tang WHW, Zannad F. Randomized Trial of a Selective Aldose Reductase Inhibitor in Patients With Diabetic Cardiomyopathy. J Am Coll Cardiol. 2024 Jul 9;84(2):137-148. doi: 10.1016/j.jacc.2024.03.380. Epub 2024 Apr 8.
Januzzi JL, Del Prato S, Rosenstock J, Butler J, Ezekowitz J, Ibrahim NE, Lam CSP, Marwick T, Wilson Tang WH, Liu Y, Mohebi R, Urbinati A, Zannad F, Perfetti R. Characterizing diabetic cardiomyopathy: baseline results from the ARISE-HF trial. Cardiovasc Diabetol. 2024 Feb 1;23(1):49. doi: 10.1186/s12933-024-02135-z.
Other Identifiers
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AT-001-2001
Identifier Type: -
Identifier Source: org_study_id
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