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Phase 1, first-in-human, randomized, ascending single-dose, placebo-controlled, double-blind study of the safety, tolerability, and bioeffect of REGN1500
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1500 | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | The primary endpoint in the study is the incidence and severity of treatment-emergent adverse events (TEAEs) through day 106/126 in participants treated with REGN1500. | Day 1 to Day 106/126 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of REGN1500 | Serum concentration of REGN1500 over time (summary statistics and PK parameters) | Day 1 to Day 106/126 |
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Inclusion Criteria:
Exclusion Criteria:
(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia | Pennsylvania | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31242752 | Derived | Ahmad Z, Banerjee P, Hamon S, Chan KC, Bouzelmat A, Sasiela WJ, Pordy R, Mellis S, Dansky H, Gipe DA, Dunbar RL. Inhibition of Angiopoietin-Like Protein 3 With a Monoclonal Antibody Reduces Triglycerides in Hypertriglyceridemia. Circulation. 2019 Aug 6;140(6):470-486. doi: 10.1161/CIRCULATIONAHA.118.039107. Epub 2019 Jun 27. | |
| 28538136 |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000621590 | evinacumab |
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| Drug |
|
| Dallas |
| Texas |
| United States |
| Dewey FE, Gusarova V, Dunbar RL, O'Dushlaine C, Schurmann C, Gottesman O, McCarthy S, Van Hout CV, Bruse S, Dansky HM, Leader JB, Murray MF, Ritchie MD, Kirchner HL, Habegger L, Lopez A, Penn J, Zhao A, Shao W, Stahl N, Murphy AJ, Hamon S, Bouzelmat A, Zhang R, Shumel B, Pordy R, Gipe D, Herman GA, Sheu WHH, Lee IT, Liang KW, Guo X, Rotter JI, Chen YI, Kraus WE, Shah SH, Damrauer S, Small A, Rader DJ, Wulff AB, Nordestgaard BG, Tybjaerg-Hansen A, van den Hoek AM, Princen HMG, Ledbetter DH, Carey DJ, Overton JD, Reid JG, Sasiela WJ, Banerjee P, Shuldiner AR, Borecki IB, Teslovich TM, Yancopoulos GD, Mellis SJ, Gromada J, Baras A. Genetic and Pharmacologic Inactivation of ANGPTL3 and Cardiovascular Disease. N Engl J Med. 2017 Jul 20;377(3):211-221. doi: 10.1056/NEJMoa1612790. Epub 2017 May 24. |
| D009750 |
| Nutritional and Metabolic Diseases |