Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
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ClinicalTrials.gov Identifier: NCT03452228 |
Recruitment Status :
Completed
First Posted : March 2, 2018
Last Update Posted : December 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Severe Hypertriglyceridemia (sHTG) | Drug: evinacumab Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Placebo-Controlled Study of Safety and Efficacy, Following Repeat-Dose Administration of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis |
Actual Study Start Date : | June 7, 2018 |
Actual Primary Completion Date : | December 17, 2019 |
Actual Study Completion Date : | July 23, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: evinacumab |
Drug: evinacumab
Administered by Intravenous (IV)
Other Name: REGN1500 |
Experimental: Placebo |
Drug: Placebo
Administered by Intravenous (IV) |
- Percent lowering of TG levels from baseline following 12 weeks of repeated IV doses of evinacumab [ Time Frame: Week 12 ]
- Percent TG lowering from baseline following 2 to 24 weeks of repeated IV doses of evinacumab [ Time Frame: Up to 24 weeks ]
- Changes in patient reported abdominal and GI daily symptom questionnaire [ Time Frame: Up to 48 weeks ]
- Changes in patient reported daily dietary habits and impact questionnaire [ Time Frame: Up to 48 weeks ]
- Degree of pancreatic injury/inflammation through 18F-2-Fluoro-2-Deoxy-D glucose positron emission tomography (18F-FDG-PET) imaging at baseline as assessed by 18F-FDG standardized uptake values SUVmax and SUVmean [ Time Frame: Baseline ]
- Change from baseline to degree of pancreatic injury/inflammation through 18F-FDG-PET imaging following 12 weeks of treatment with evinacumab as assessed by 18F-FDG standardized uptake values SUVmax and SUVmean [ Time Frame: Week 12 ]
- Degree of pancreatic injury/inflammation through Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI) at baseline as assessed by ADC [ Time Frame: Baseline ]
- Change from baseline to degree of pancreatic injury/inflammation through DW-MRI following 12 weeks of treatment with evinacumab as assessed by ADC [ Time Frame: Week 12 ]
- Change from baseline to degree of pancreatic injury/inflammation through DW-MRI following 24 weeks of treatment with evinacumab as assessed by ADC [ Time Frame: Week 24 ]
- Total evinacumab concentration in serum [ Time Frame: Up to 48 weeks ]
- Total ANGPTL3 concentrations [ Time Frame: Up to 48 weeks ]
- Incidence of anti-drug antibody (ADA) [ Time Frame: Up to 48 weeks ]
- Incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 48 weeks ]
- Incidence of serious adverse events (SAEs) [ Time Frame: Up to 48 weeks ]
- Incidence of laboratory abnormalities [ Time Frame: Up to 48 weeks ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Previous documentation in the patient's medical records of a fasting serum TG measurement ≥ 1000 mg/dL (11.3 mmol/L) on more than 1 occasion, and all fasting TG values ≥500 mg/dL (5.6 mmol/L) at screening
- History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years
- On stable lipid-modifying diet with or without medications (eg, statins, niacin, omega-3 fatty acids). Lipid-modifying diet and doses of medications should be stable for at least 4 weeks (6 weeks for fibrates, 8 weeks for PCSK9 inhibitors) prior to screening
- Body mass index (BMI) of 18-40 kg/m2
Key Exclusion Criteria:
- A hospital or clinic discharge diagnosis of acute pancreatitis within 12 weeks of screening
- Lipid apheresis or plasma exchange treatment within the last 4 weeks or plans to undergo apheresis or plasma exchange during the time frame of the study
- History of class 3/4 heart failure at any time in the past, or hospitalization for heart failure, diagnosis of a myocardial infarction, stroke, Transient ischemic attack (TIA), unstable angina, Coronary artery bypass surgery (CABG), Percutaneous coronary intervention (PCI), carotid surgery/stenting within 3 months before the screening visit
- History of bleeding disorders, esophageal varices, heparin induced thrombocytopenia, or contraindications to receiving heparin (eg, allergic reaction to heparin)
- Previous treatment with Glybera® in the past 5 years or treatment with lomitapide or mipomersen in the past 6 months
- Pregnant or breast feeding women
Note: Other protocol defined Inclusion/Exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452228
United States, Florida | |
Regeneron Research Facility | |
Boca Raton, Florida, United States, 33434 | |
United States, Georgia | |
Regeneron Research Facility | |
Atlanta, Georgia, United States, 30328 | |
United States, Kansas | |
Regeneron Research Facility | |
Kansas City, Kansas, United States, 66160 | |
United States, New York | |
Regeneron Research Facility | |
New York, New York, United States, 10029 | |
United States, Pennsylvania | |
Regeneron Research Facility | |
Philadelphia, Pennsylvania, United States, 19104 | |
Regeneron Research Facility | |
Pittsburgh, Pennsylvania, United States, 15261 | |
United States, Texas | |
Regeneron Research Facility | |
Dallas, Texas, United States, 75390 | |
Regeneron Research Facility | |
Houston, Texas, United States, 77030 | |
United States, Wisconsin | |
Regeneron Research Facility | |
Milwaukee, Wisconsin, United States, 53226 | |
Canada, Quebec | |
Regeneron Research Facility | |
Chicoutimi, Quebec, Canada, G7H7K9 | |
Regeneron Research Facility | |
Québec, Quebec, Canada, G1V4W2 | |
Italy | |
Regeneron Research Facility | |
Napoli, Campania, Italy, 80131 | |
Regeneron Research Facility | |
Rome, Italy, 00161 | |
United Kingdom | |
Regeneron Research Facility | |
Birmingham, United Kingdom, B15 2TH | |
Regeneron Research Facility | |
London, United Kingdom, NW3 2QG | |
Regeneron Research Facility | |
London, United Kingdom, SE1 7EH | |
Regeneron Research Facility | |
Manchester, United Kingdom, M13 9WL |
Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
Responsible Party: | Regeneron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03452228 |
Other Study ID Numbers: |
R1500-HTG-1522 2016-003307-62 ( EudraCT Number ) |
First Posted: | March 2, 2018 Key Record Dates |
Last Update Posted: | December 24, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pancreatitis Hypertriglyceridemia Pancreatic Diseases Digestive System Diseases |
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |