Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN1500/kg · 1 trial · 1 indication
Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.
| Arm | Type | Description |
|---|---|---|
| Open-label | EXPERIMENTAL | Open-label REGN1500 |
| Name | Type | Description |
|---|---|---|
| REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | DRUG | Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period. |
Inclusion Criteria: 1. Men and women ≥18 years of age at the time of the screening visit 2. Diagnosis of homozygous familial hypercholesterolemia (HoFH) 3. Willing to consistently maintain usual diet for the duration of the study Exclusion Criteria: 1. Background medical lipid modifying therapy t...
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.