Approval Probability
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Adjusted LOA
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MLDL1278A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MLDL1278A | DRUG | Single intravenous dose |
| placebo | DRUG | Repeating intravenous dose |
| statin, stable dose | DRUG | Repeating oral dose |
Inclusion Criteria: * Evidence of qualifying vessel (carotid or aortic) plaque inflammation * Documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk * Use of a stable dose of statin therapy...
MLDL1278A is an investigational small molecule being studied for the treatment of atherosclerosis, a condition characterized by the buildup of plaque in the arteries. It is administered intravenously and is being evaluated in patients with stable atherosclerotic cardiovascular disease who are already receiving standard-of-care therapy.
MLDL1278A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is currently in Phase 2 clinical development for atherosclerosis, a cardiovascular condition.
MLDL1278A is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.
MLDL1278A has been studied in one completed Phase 2 clinical trial with the identifier NCT01258907. This trial, known as GLACIER, evaluated the safety, tolerability, and activity of intravenous MLDL1278A in patients with stable atherosclerotic cardiovascular disease. The trial enrolled 147 participants in the United States and Canada.
MLDL1278A is the drug being studied in the GLACIER clinical trial, which has the identifier NCT01258907. GLACIER is the name of the trial, not an alternative name for the drug itself. The trial evaluated the safety, tolerability, and activity of MLDL1278A in patients with atherosclerosis.