NCT04083339

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

Aldose Reductase Inhibition for Stabilization of Exercise Capacity in Heart Failure (ARISE-HF): A Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 675 (estimated)
• Sponsor: Applied Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study consists of two consecutive parts: Part A and Part B. Part A will evaluate the safety and efficacy of two doses of AT-001 vs placebo. The primary objective of Part A is to demonstrate that AT-001 improves or prevents the decline of functional capacity in patients with Diabetic Cardiomyopathy. Part B is an extension of at least 12 months that will evaluate the safety and efficacy of chronic administration of AT-001 vs placebo in the same patients who had previously been evaluated in Part A. Assessments in Part B will include safety endpoints and exploratory clinical efficacy endpoints, i.e. death and hospitalization due to a cardiac event.

Conditions

• Diabetic Cardiomyopathies

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-09-20
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2019-09-10
• Last updated: 2022-12-08

Locations

79 sites across 10 countries: United States, Australia, Canada, Czechia, France, Germany, Hong Kong, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study