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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04863014
Collaborator
(none)
120
Enrollment
33
Locations
2
Arms
39.4
Anticipated Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to determine the proportion of patients with elevated triglycerides (TG), 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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 12, 2021
Anticipated Primary Completion Date :
Oct 22, 2024
Anticipated Study Completion Date :
Oct 22, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: evinacumab

Randomized 1:1

Drug: evinacumab
Intravenous infusion every 4 weeks (Q4W)
Other Names:
  • REGN1500
  • Evkeeza™

    		•
    Placebo Comparator: Placebo

    Randomized 1:1

    Other: Placebo
    Intravenous infusion Q4W

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with at least 1 positively adjudicated acute pancreatitis (AP) episode [Up to 52 weeks]

    Secondary Outcome Measures

    1. Percent change in ApoC3 [Baseline to week 52]

    2. Percent change in fasting triglycerides (TGs) [Baseline to week 52]

    3. Percent change in total cholesterol (TC) [Baseline to week 52]

    4. Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) [Baseline to week 52]

    5. Percent change in ApoB48 [Baseline to week 52]

    6. Percent change in ApoB100 levels [Baseline to week 52]

    7. Percent change in nuclear magnetic resonance (NMR)-determined particle size and number [Baseline to week 52]

    8. Number of independently adjudicated episodes of AP per patient [Up to 52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    1. Adults without FCS due to LPL loss of function mutations

    2. Documented history of 1 HTG-associated AP episode within 24 months of screening

    3. Fasting serum TG value >880 mg/dL (10 mmol/L) or >500 mg/dL (5.6mmol/L) determined during the screening period as described in the protocol

    4. Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study

    5. Body mass index ≥18.0 and ≤45.0 kg/m2

    6. 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

    6. Has received a COVID-19 vaccination within 1-week of planned start medication or for which the planned COVID-19 vaccination would not be completed 1-week prior to start of the study

    Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radin Cardivascular Medical Group, Inc Newport Beach California United States 92663
    2 Yale Cancer Center - Yale University New Haven Connecticut United States 06510
    3 Excel Medical Clinical Trials, LLC Boca Raton Florida United States 33434
    4 Harmony Medical Research Institute, Inc. Hialeah Florida United States 33015
    5 Advocate Medical Group Midwest Heart Specialists Park Ridge Illinois United States 60068
    6 Methodist Medical Center of Illiniois - UnityPoint Clinic Peoria Illinois United States 61636
    7 Quincy Medical Group Quincy Illinois United States 62301
    8 St. Vincent Medical Group, Inc. Carmel Indiana United States 46290
    9 University of Kansas Medical Center Kansas City Kansas United States 66160
    10 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287
    11 Minneapolis Heart Institute Minneapolis Minnesota United States 55407
    12 University of Minnesota Minneapolis Minnesota United States 55422
    13 Washington University School of Medicine Saint Louis Missouri United States 63110
    14 Northwell Health Manhasset New York United States 11030
    15 NYU Langone Hospital - Long Island Mineola New York United States 11501
    16 Weill Cornell Medical College New York New York United States 10021
    17 Mt Sinai - Ichan Medical Institute New York New York United States 10029
    18 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    19 Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
    20 University Of Pittsburgh Pittsburgh Pennsylvania United States 15213
    21 Medical University of South Carolina Charleston South Carolina United States 29425
    22 University Diabetes & Endocrine Consultants Chattanooga Tennessee United States 37411
    23 Sante Clinical Research Kerrville Texas United States 78028
    24 Briggs Clinical Research LLC San Antonio Texas United States 78224
    25 University of Washington Seattle Washington United States 98109
    26 MultiCare Institute for Research Spokane Washington United States 99202
    27 West Virginia University Heart & Vascular Institute Morgantown West Virginia United States 26506
    28 Wisconsin Center for Advanced Research - a division of GI Associates, LLC Milwaukee Wisconsin United States 53215
    29 Robarts Research Institute London Ontario Canada N6A 5B7
    30 Centre Etudes Cliniques Ecogene-21 Chicoutimi Quebec Canada G7H 7K9
    31 Clinique des maladies lipidiques de Quebec Quebec Canada G1V 4W2
    32 Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC) Amsterdam Netherlands 1105 AZ
    33 Ziekenhuis Rijnstate Arnhem Netherlands 6815 AD

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04863014
    Other Study ID Numbers:
    • R1500-HTG-20118
    • 2021-000437-13
    First Posted:
    Apr 28, 2021
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Regeneron Pharmaceuticals
    Severe Hypertriglyceridemia (HTG)
    Recurrent Acute Pancreatitis
    Additional relevant MeSH terms:
    Pancreatitis
    Hypertriglyceridemia

    Study Results

    No Results Posted as of Jul 14, 2022