← Back to Search

Unknown

AT-001 for Diabetic Cardiomyopathy

Phase 3
Waitlist Available
Research Sponsored by Applied Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diabetic cardiomyopathy
Diabetic cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months after randomization]
Awards & highlights

Study Summary

This trial will test a new medication to see if it can help people with diabetic cardiomyopathy who are at high risk for heart failure.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects for AT-001 aren't listed here, common ones may include potential risks related to heart function, reactions at injection sites, gastrointestinal symptoms, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have heart problems related to diabetes.
Select...
I have heart problems due to diabetes.
Select...
I have Type 2 Diabetes.
Select...
My exercise capacity is less than 75% of what's expected for my age and gender.
Select...
I have heart problems related to diabetes.
Select...
I have Type 2 Diabetes.
Select...
I have Type 2 Diabetes.
Select...
My exercise capacity is below 75% of what's expected for my age and gender.
Select...
I have Type 2 Diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months after randomization]
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months after randomization] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak VO2 during cardio-pulmonary exercise test (CPET);
Secondary outcome measures
Changes in NT-proBNP
Changes in the modified Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Progression to overt heart failure (Stage C Heart Failure)
Other outcome measures
Changes in echocardiographic parameters
Worsening of diabetic cardiomyopathy

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AT-001
2016
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Applied Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
210 Total Patients Enrolled
James L Januzzi, MDStudy ChairHarvard Medical School (HMS and HSDM)
4 Previous Clinical Trials
1,448 Total Patients Enrolled

Media Library

AT-001 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04083339 — Phase 3
Cardiomyopathy Research Study Groups: AT-001 High dose, Placebo Comparator, AT-001 Low Dose
Cardiomyopathy Clinical Trial 2023: AT-001 Highlights & Side Effects. Trial Name: NCT04083339 — Phase 3
AT-001 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083339 — Phase 3
Cardiomyopathy Patient Testimony for trial: Trial Name: NCT04083339 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any short-term or long-term risks associated with taking AT-001?

"AT-001 has received a safety rating of 3. This is due to the fact that it is a Phase 3 trial, and there is thus some data supporting both efficacy and safety."

Answered by AI

Is this research still looking for new participants?

"The information available on clinicaltrials.gov indicates that this trial is still actively recruiting patients. The trial was first posted on September 20th, 2019 and was last updated on February 25th, 2022. There are 38 different recruitment sites across the globe and the study is looking for 675 participants in total."

Answered by AI

Have these treatments been tested before on humans?

"AT-001 is being tested in 2 ongoing trials, which began in 2019. The trials, conducted in 45 cities across 10 countries, have recruited 675 and 18241 participants, respectively. The sponsor of these trials is Applied Therapeutics, Inc."

Answered by AI

What other drugs have been trialed with AT-001?

"There are 2 ongoing clinical trials for AT-001, with 1 of them being in Phase 3. Even though the majority of research for AT-001 is based in Houston, Texas, there are actually 81 clinical trial sites for this medication."

Answered by AI

Is this clinical trial active in several hospitals across Canada?

"There are 38 clinical trial sites available for this study, including the Centre for Studies in Family Medicine, the Western Centre for Public Health and Family Medicine, and Western University in London, Ecogene-21 in Chicoutimi, and BC Diabetes in Vancouver."

Answered by AI

How many patients are being monitored in this clinical trial?

"In order to run this clinical trial, 675 individuals that meet the pre-determined inclusion criteria are required to enroll. These potential patients can come from various recruitment sites, such as the Centre for Studies in Family Medicine, Western Centre for Public Health and Family Medicine, Western University in London, Ontario and Ecogene-21 in Chicoutimi, Quebec."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Virginia
California
Other
How old are they?
18 - 65
65+
What site did they apply to?
Metabolic Institute of America
New Generation of Medical Research
Other
University of California, Irvine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
0

Why did patients apply to this trial?

Kingsport tn is close to me. Unsatisfied with current results. I have CAD, which I understand could lead to Cardiomyopathy, if I’m correct. I want to improve myself and help others to live a longer life.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long is the study?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Progressive Medical Research: < 48 hours
Average response time
  • < 2 Days
~123 spots leftby Mar 2025