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MEDI6570 · 2 trials · 3 indications
To evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebo. The primary endpoint of change in NCPVMD from baseline to Day 253 was assessed based on the CTA Analysis Populations.
Measured by the incidence of treatment- emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
| Arm | Type | Description |
|---|---|---|
| MEDI6570 Low dose | EXPERIMENTAL | Monthly Subcutaneous administration. |
| MEDI6570 Medium dose | EXPERIMENTAL | Monthly Subcutaneous administration. |
| MEDI6570 High dose | EXPERIMENTAL | Monthly Subcutaneous administration. |
| Placebo Low dose | PLACEBO_COMPARATOR | Monthly Subcutaneous administration. |
| Placebo Medium dose | PLACEBO_COMPARATOR | Monthly Subcutaneous administration |
| Placebo High dose | PLACEBO_COMPARATOR | Monthly Subcutaneous administration |
| Part A MEDI6570 Cohort 1 | EXPERIMENTAL | Part A MEDI6570 Cohort 1 dose level |
| Part A MEDI6570 Cohort 2 | EXPERIMENTAL | Part A MEDI6570 Cohort 2 dose level |
| Part A MEDI6570 Cohort 3 | EXPERIMENTAL | Part A MEDI6570 Cohort 3 dose level |
| Part A MEDI6570 Cohort 4 | EXPERIMENTAL | Part A MEDI6570 Cohort 4 dose level |
| Part A Placebo | PLACEBO_COMPARATOR | Part A Placebo |
| Part B MEDI6570 Cohort 1 | EXPERIMENTAL | Part B MEDI6570 Cohort 1 dose level |
| Part B MEDI6570 Cohort 2 | EXPERIMENTAL | Part B MEDI6570 Cohort 2 dose level |
| Part B MEDI6570 Cohort 3 | EXPERIMENTAL | Part B MEDI6570 Cohort 3 dose level |
| Part B Placebo | PLACEBO_COMPARATOR | Part B Placebo |
| Part A MEDI6570 Cohort 5 | EXPERIMENTAL | Part A MEDI6570 Cohort 5 Dose level |
| Part A MEDI6570 Cohort 6 | EXPERIMENTAL | Part A MEDI6570 Cohort 6 dose level |
| Name | Type | Description |
|---|---|---|
| MEDI6570 | BIOLOGICAL | MEDI6570 |
| Placebo | BIOLOGICAL | Buffer |
| Part B Placebo | BIOLOGICAL | Placebo |
Inclusion Criteria: 1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization within 42 days after signing the full ICF, and must adhere to the schedules of activities. 2. Women must be ≥ 40 y...
MEDI6570 is an investigational monoclonal antibody being developed for cardiovascular conditions, specifically coronary heart disease (CHD) and atherosclerosis. It has been studied in patients with a history of myocardial infarction and in subjects with type 2 diabetes mellitus who also have atherosclerosis or cardiovascular disease.
MEDI6570 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. It is being investigated for its potential effects on atherosclerosis and coronary heart disease, though the precise biological pathway it modulates is not publicly detailed.
MEDI6570 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for cardiovascular indications.
MEDI6570 has completed a Phase 1 trial and a Phase 2 trial. The Phase 1 study evaluated single and multiple ascending doses, while the Phase 2 study assessed efficacy and safety in patients with a history of myocardial infarction. The drug remains investigational and is not yet approved.
MEDI6570 has been studied in two completed clinical trials. NCT03654313 was a Phase 1 dose-escalation study in subjects with type 2 diabetes mellitus, enrolling 88 participants. NCT04610892 was a Phase 2 efficacy and safety trial in patients with a history of myocardial infarction, enrolling 423 participants across multiple countries.
No alternative names for MEDI6570 have been disclosed in available information. The drug is identified solely by its development code MEDI6570, and no other brand or chemical names have been publicly associated with this investigational monoclonal antibody.