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Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

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ClinicalTrials.gov Identifier: NCT04863014
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the study is to determine the proportion of patients with triglycerides (TG) >880 mg/dL, without familial chylomicronemia syndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL), and a history of hypertriglyceridemia (HTG)-associated acute pancreatitis (AP) who experience a recurrent episode of AP after treatment with evinacumab versus placebo.

The secondary objectives of the study are:

  • To determine the change in the standard lipid profile after therapy with evinacumab versus placebo
  • To determine the changes in specialty lipoprotein parameters (ApoC3, ApoB48, ApoB100, and nuclear magnetic resonance [NMR] lipid profile) after therapy with evinacumab versus placebo
  • To measure the number of AP episodes per patient
  • To assess the safety and tolerability of evinacumab
  • To assess the potential immunogenicity of evinacumab
  • To assess the concentrations of total evinacumab and total angiopoietin-like 3 (ANGPTL3)

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: evinacumab Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : October 22, 2024
Estimated Study Completion Date : October 22, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: evinacumab
Randomized 1:1
Drug: evinacumab
Intravenous infusion every 4 weeks (Q4W)
Other Name: REGN1500

Placebo Comparator: Placebo
Randomized 1:1
Other: Placebo
Intravenous infusion Q4W




Primary Outcome Measures :
  1. Proportion of patients with at least 1 positively adjudicated acute pancreatitis (AP) episode [ Time Frame: Up to 52 weeks ]

Secondary Outcome Measures :
  1. Percent change in ApoC3 [ Time Frame: Baseline to week 52 ]
  2. Percent change in fasting triglycerides (TGs) [ Time Frame: Baseline to week 52 ]
  3. Percent change in total cholesterol (TC) [ Time Frame: Baseline to week 52 ]
  4. Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: Baseline to week 52 ]
  5. Percent change in ApoB48 [ Time Frame: Baseline to week 52 ]
  6. Percent change in ApoB100 levels [ Time Frame: Baseline to week 52 ]
  7. Percent change in nuclear magnetic resonance (NMR)-determined particle size and number [ Time Frame: Baseline to week 52 ]
  8. Number of independently adjudicated episodes of AP per patient [ Time Frame: Up to 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Documented history of HTG-associated AP within 15 months of screening
  2. Fasting serum TG value >880 mg/dL (10 mmol/L) on 2 occasions at least 2 days apart determined during the screening period.
  3. Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study
  4. Body mass index ≥18.0 and ≤40.0 kg/m2
  5. Compliance with a stable diet and exercise regimen at screening and willingness to continue the diet through the end of the study

Key Exclusion Criteria:

  1. Hospitalization for AP within 4 weeks of screening
  2. Known genetic FCS defined as homozygous or compound heterozygous LoF mutations in LPL as defined in the protocol
  3. Symptomatic gallstone disease within 6 months prior to screening as defined in the protocol
  4. Use of any medication or nutraceutical known to alter serum lipids which has not been part of a stable therapeutic regimen for at least 8 weeks, and there are no plans to change the regimen during the study
  5. Presence of any clinically significant, uncontrolled endocrine disease known to influence serum lipids as defined in the protocol

Note: Other protocol-defined Inclusion/ Exclusion Criteria 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): NCT04863014


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

Locations
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United States, Florida
Regeneron Research Site Recruiting
Boca Raton, Florida, United States, 33434
United States, Texas
Regeneron Research Site Recruiting
San Antonio, Texas, United States, 78224
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: NCT04863014    
Other Study ID Numbers: R1500-HTG-20118
2021-000437-13 ( EudraCT Number )
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Severe HTG
Recurrent Acute Pancreatitis
Additional relevant MeSH terms:
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Pancreatitis
Hypertriglyceridemia
Pancreatic Diseases
Digestive System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases