Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04083339 | Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy | PHASE3 | ACTIVE NOT_RECRUITING | 675 | — | — | Sep 20, 2019 | Dec 1, 2025 | Dec 8, 2022 | 79 | United States, Australia +8 |
Changes in Peak VO2 during cardio-pulmonary exercise test (CPET) from baseline to approximately Month 15 (15-18 months). A CPET may be repeated at approximately Month 27 (27-30 months).
| Arm | Type | Description |
|---|---|---|
| AT-001 High dose | EXPERIMENTAL | 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). |
| AT-001 Low Dose | EXPERIMENTAL | 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). |
| Placebo Comparator | PLACEBO_COMPARATOR | Placebo capsules will be used as comparator |
| Name | Type | Description |
|---|---|---|
| AT-001 | DRUG | 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 |
| Placebo | DRUG | Matching placebo will be administered as 3 capsules twice daily, before breakfast and before dinner |
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 e...