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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 : Recruiting
First Posted : March 2, 2018
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The primary objective is to determine the change in Triglyceride (TG) levels following 12 weeks of repeated Intravenous (IV) doses of evinacumab.

Condition or disease Intervention/treatment Phase
Severe Hypertriglyceridemia (sHTG) Drug: evinacumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : May 18, 2020
Estimated Study Completion Date : January 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: evinacumab Drug: evinacumab
Administered by Intravenous (IV)
Other Name: REGN1500

Experimental: Placebo Drug: Placebo
Administered by Intravenous (IV)




Primary Outcome Measures :
  1. Percent lowering of TG levels from baseline following 12 weeks of repeated IV doses of evinacumab [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Percent TG lowering from baseline following 2 to 24 weeks of repeated IV doses of evinacumab [ Time Frame: Up to 24 weeks ]
  2. Changes in patient reported abdominal and GI daily symptom questionnaire [ Time Frame: Up to 48 weeks ]
  3. Changes in patient reported daily dietary habits and impact questionnaire [ Time Frame: Up to 48 weeks ]
  4. 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 ]
  5. 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 ]
  6. Degree of pancreatic injury/inflammation through Diffusion Weighted-Magnetic Resonance Imaging (DW-MRI) at baseline as assessed by ADC [ Time Frame: Baseline ]
  7. 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 ]
  8. 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 ]
  9. Total evinacumab concentration in serum [ Time Frame: Up to 48 weeks ]
  10. Total ANGPTL3 concentrations [ Time Frame: Up to 48 weeks ]
  11. Incidence of anti-drug antibody (ADA) [ Time Frame: Up to 48 weeks ]
  12. Incidence of Treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 48 weeks ]
  13. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 48 weeks ]
  14. 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
Criteria

Key Inclusion Criteria:

  1. 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
  2. History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years
  3. 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
  4. Body mass index (BMI) of 18-40 kg/m2

Key Exclusion Criteria:

  1. A hospital or clinic discharge diagnosis of acute pancreatitis within 12 weeks of screening
  2. 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
  3. 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
  4. History of bleeding disorders, esophageal varices, heparin induced thrombocytopenia, or contraindications to receiving heparin (eg, allergic reaction to heparin)
  5. Previous treatment with Glybera® in the past 5 years or treatment with lomitapide or mipomersen in the past 6 months
  6. Pregnant or breast feeding women

Note: Other protocol defined Inclusion/Exclusion criteria may apply


Information from the National Library of Medicine

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


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Colorado
Regeneron Research Facility Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Regeneron Research Facility Recruiting
Boca Raton, Florida, United States, 33434
United States, Georgia
Regeneron Research Facility Recruiting
Atlanta, Georgia, United States, 30328
United States, Kansas
Regeneron Research Facility Recruiting
Kansas City, Kansas, United States, 66160
United States, New York
Regeneron Research Facility Recruiting
New York, New York, United States, 10029
United States, Pennsylvania
Regeneron Research Facility Recruiting
Philadelphia, Pennsylvania, United States, 19104
Regeneron Research Facility Recruiting
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
Regeneron Research Facility Recruiting
Dallas, Texas, United States, 75390
Regeneron Research Facility Recruiting
Houston, Texas, United States, 77030
United States, Wisconsin
Regeneron Research Facility Recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, Quebec
Regeneron Research Facility Recruiting
Chicoutimi, Quebec, Canada, G7H7K9
Regeneron Research Facility Recruiting
Québec, Quebec, Canada, G1V4W2
Italy
Regeneron Research Facility Recruiting
Napoli, Campania, Italy, 80131
Regeneron Research Facility Recruiting
Rome, Italy, 00161
United Kingdom
Regeneron Research Facility Recruiting
Birmingham, United Kingdom, B15 2TH
Regeneron Research Facility Recruiting
London, United Kingdom, NW3 2QG
Regeneron Research Facility Recruiting
London, United Kingdom, SE1 7EH
Regeneron Research Facility Recruiting
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03452228     History of Changes
Other Study ID Numbers: R1500-HTG-1522
2016-003307-62 ( EudraCT Number )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Hypertriglyceridemia
Pancreatic Diseases
Digestive System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs