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REGN1500 · 2 trials · 2 indications
Safety of REGN1500 will be assessed by physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations from visit 1 to day 183 \[EOS (end of study)\]
| Arm | Type | Description |
|---|---|---|
| dosing cohort 1 | EXPERIMENTAL | Patients will receive REGN1500 or placebo in dosing cohort 1 |
| dosing cohort 2 | EXPERIMENTAL | Patients will receive REGN1500 or placebo in dosing cohort 2 |
| dosing cohort 3 | EXPERIMENTAL | Patients will receive REGN1500 or placebo in dosing cohort 3 |
| dosing cohort 4 | EXPERIMENTAL | Patients will receive REGN1500 or placebo in dosing cohort 4 |
| dosing cohort 5 | EXPERIMENTAL | Patients will receive REGN1500 or placebo in dosing cohort 5 |
| Group A: Cohorts 1 through 6 | EXPERIMENTAL | Group A: Cohorts 1 through 3 will receive REGN1500 subcutaneous (SC) or placebo Cohorts 4 through 6 will receive REGN1500 intravenous (IV) or placebo |
| Group B | EXPERIMENTAL | Group B will receive REGN1500 IV or placebo |
| Group C: Cohorts 1 and 2 | EXPERIMENTAL | Group C: Cohort 1 will receive REGN1500 SC or placebo Cohort 2 will receive REGN1500 IV or placebo |
| Name | Type | Description |
|---|---|---|
| REGN1500 | DRUG | - |
| placebo | DRUG | - |
Inclusion Criteria: * Provide signed informed consent * Otherwise healthy men and women ages 18 to 65 years, inclusive * Body mass index of 18.0 kg/m2to 38.0 kg/m2, inclusive * Normal standard 12-lead ECG * Willing to refrain from the consumption of alcohol for 24 hours prior to each study visit * ...
REGN1500 is an investigational small molecule being developed for metabolic disorders, including hypertriglyceridemia and homozygous familial hypercholesterolemia (HoFH). It has been studied in clinical trials for these conditions, though it remains in clinical development and is not approved.
REGN1500 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. Regeneron has conducted clinical trials of REGN1500 in the United States, Canada, and the Netherlands.
REGN1500 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in participants with homozygous familial hypercholesterolemia. REGN1500 is investigational and has not been approved by regulatory authorities.
REGN1500 has been studied in three completed trials: NCT01749878, a Phase 1 single ascending dose study in 99 participants with hypertriglyceridemia; NCT02107872, a Phase 1 multiple ascending dose study in 55 participants with metabolic disorders; and NCT02265952, a Phase 2 study in 9 participants with homozygous familial hypercholesterolemia.
No, REGN1500 is not the same as evinacumab. REGN1500 is a small molecule, whereas evinacumab is a monoclonal antibody. They are distinct investigational drugs developed by Regeneron for different purposes in lipid metabolism.