Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Applied Therapeutics, Inc.
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.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Type 2 Diabetes Mellitus
Diabetic cardiomyopathy
Peak VO2 \< 75% of predicted normal value based on age and gender
You may not be if
Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure
Prior echocardiogrphic measurement of ejection fraction (EF) \< 40%