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

NCT04083339 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 675

Last updated 2022-12-08

No results posted yet for this 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.

Conditions

  • Diabetic Cardiomyopathies

Interventions

DRUG

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Applied Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • James L Januzzi, MD · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-20
Primary Completion
2023-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04083339 on ClinicalTrials.gov