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.

Age: 40 Years and older

Gender: All

Start Date: 09/20/2019

Primary Completion Date (Estimated): 12/01/2023

Study Completion Date (Estimated): 12/01/2025

Accepts Healthy Volunteers: No

Trial Purpose and 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.

Eligibility Criteria

Age: 40 Years and older

Gender: All

Accepts Healthy Volunteers: No

Inclusion criteria:

* Type 2 Diabetes Mellitus

* Diabetic cardiomyopathy

* Peak VO2 \< 75% of predicted normal value based on age and gender

Exclusion criteria:

* Prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage C heart failure

* 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