Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI6012 · 3 trials · 4 indications
Global infarct size expressed as a percentage of left ventricle (LV) mass measured on delayed-enhanced cardiovascular magnetic resonance (CMR) imaging in 10-12 weeks post myocardial infarction (MI) is reported.
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 56 days after last dose of study drug (Day 66 for Cohort 4 and placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm) that were absent before treatment or that worsened relative to pre-treatment state.
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.
Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, respiration rate, heart rate, pulse oximetry, and body temperature.
Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol.
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol ester.
The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of cholesterol ester.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
TEAEs observed in participants with clinically significant ECG abnormalities were assessed. TEAEs are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
TEAEs observed in participants with clinically significant vital signs abnormalities were assessed. Vital signs parameters included blood pressure, respiration rate, pulse, pulse oximetry, and body temperature.
An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of HDL-C.
| Arm | Type | Description |
|---|---|---|
| Cohort A: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3 by IV push. |
| Cohort A: MEDI6012 | EXPERIMENTAL | Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push. |
| Cohort B: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push. |
| Cohort B: MEDI6012 | EXPERIMENTAL | Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push. |
| MEDI6012 40 mg | EXPERIMENTAL | Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15. |
| Placebo | PLACEBO_COMPARATOR | Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15. |
| MEDI6012 120 mg | EXPERIMENTAL | Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15. |
| MEDI6012 300 mg | EXPERIMENTAL | Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15. |
| MEDI6012 IV Push | EXPERIMENTAL | Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively. |
| Placebo IV Push | PLACEBO_COMPARATOR | Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10. |
| MEDI6012 24 mg IV | EXPERIMENTAL | Participants received a single IV dose of 24 mg MEDI6012 on Day 1. |
| MEDI6012 80 mg IV | EXPERIMENTAL | Participants received a single IV dose of 80 mg MEDI6012 on Day 1. |
| MEDI6012 240 mg IV | EXPERIMENTAL | Participants received a single IV dose of 240 mg MEDI6012 on Day 1. |
| MEDI6012 800 mg IV | EXPERIMENTAL | Participants received a single IV dose of 800 mg MEDI6012 on Day 1. |
| MEDI6012 80 mg SC | EXPERIMENTAL | Participants received a single SC dose of 80 mg MEDI6012 on Day 1. |
| Placebo Intravenous (IV) | PLACEBO_COMPARATOR | Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study. |
| MEDI6012 600 mg SC | EXPERIMENTAL | Participants received a single SC dose of 600 mg MEDI6012 on Day 1. |
| Placebo Subcutaneous (SC) | PLACEBO_COMPARATOR | Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study. |
| Name | Type | Description |
|---|---|---|
| MEDI6012 | BIOLOGICAL | MEDI6012 |
| Placebo | OTHER | Placebo |
| MEDI6012 40 mg | DRUG | Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15. |
| MEDI6012 120 mg | DRUG | Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15. |
| MEDI6012 300 mg | DRUG | Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15. |
| Placebo IV Push | DRUG | Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10. |
| MEDI6012 IV Push | DRUG | Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively. |
| Placebo SC | BIOLOGICAL | Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study. |
| Placebo IV | BIOLOGICAL | Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study. |
Inclusion Criteria: * Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation * Planned for primary PCI (percutaneous coronary intervention) * Men and women without child-bearing potential aged 30-80 years of age * Capable and willing to provide informed consent. * Capabl...
MEDI6012 is an investigational small molecule being studied for cardiovascular conditions, including atherosclerosis, coronary artery disease, and ST elevation myocardial infarction. It has been evaluated in Phase 2 clinical trials for these indications.
MEDI6012 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN.
MEDI6012 is in Phase 2 clinical development. It has completed multiple Phase 2 trials, but it is not yet approved and remains an investigational drug.
MEDI6012 has been studied in three completed Phase 2 trials: NCT02601560 in stable coronary artery disease, NCT03004638 in stable atherosclerotic cardiovascular disease, and NCT03578809 in acute ST elevation myocardial infarction.
No alternative names for MEDI6012 have been disclosed. It is identified solely by its code name MEDI6012 in clinical trial registries and development records.