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This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dosing cohort 1 | Experimental | Patients will receive REGN1500 or placebo in dosing cohort 1 |
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| dosing cohort 2 | Experimental | Patients will receive REGN1500 or placebo in dosing cohort 2 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN1500 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 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)] | visit 1 to day 183 (EOS) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration | Serum concentration, amount of REGN1500 in the circulation, over time (visit 1 to day 183) | visit 1 to day 183 |
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Inclusion Criteria:
Exclusion Criteria:
Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daytona Beach | Florida | 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. |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000621590 | evinacumab |
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| placebo |
| Drug |
|
| Evansville |
| Indiana |
| United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |