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

Browse trials for

• Pancreatitis 752
• Hypertriglyceridemia 296

Keywords

• Severe Hypertriglyceridemia (HTG)
• Recurrent Acute Pancreatitis

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's enrollment of 21 is below the median of 80 across 448 interventional studies indexed under Pancreatitis.

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Eligibility criteria

Study arms

• Experimental
  evinacumab

  Randomized 1:1

  Drug: evinacumab

• Placebo comparator
  Placebo

  Randomized 1:1

  Other: Placebo

Interventions

• Drugevinacumab

  Intravenous infusion every 4 weeks (Q4W)

  Also known as: REGN1500, Evkeeza™

• OtherPlacebo

  Intravenous infusion Q4W

Primary outcomes

1. Percentage of Participants With at Least One Positively Adjudicated Acute Pancreatitis (AP) Episode

   All AP (Acute Pancreatitis) episodes occurred post-study drug treatment.

   Time frame: Baseline to 52 weeks

Secondary outcomes

1. Percent Change in Apolipoprotein C3 (ApoC3) From Baseline to Week 52

   Apolipoproteins transport lipids through the body by binding with fat and cholesterol to form lipoproteins. ApoC3 was a component of very-low-density lipoproteins (VLDL), high-density lipoprotein (HDL), and triglyceride-rich chylomicrons and regulates lipid metabolism. Percent change in ApoC3 from Baseline to Week 52 was reported.

   Time frame: Baseline to week 52

2. Percent Change in Fasting Triglycerides (TGs) - (From Baseline to Week 52)

   Time frame: Baseline to week 52

3. Percent Change in Total Cholesterol (TC) - (Baseline to Week 52)

   Time frame: Baseline to week 52

4. Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) - (From Baseline to Week 52)

   Time frame: Baseline to week 52

5. Percent Change in Apolipoprotein B48 (ApoB48) From Baseline to Week 52

   Time frame: Baseline to week 52

6. Percent Change in Apolipoprotein B100 (ApoB100) Levels From Baseline to Week 52

   Time frame: Baseline to week 52

7. Percent Change in Nuclear Magnetic Resonance (NMR)-Determined Particle Size and Number From Baseline to Week 52

   Time frame: Baseline to week 52

8. Number of Independently Adjudicated Positive Episodes of Acute Pancreatitis (AP) Per Participant

   Time frame: Up to 52 weeks

9. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

   Time frame: From start of study drug administration up to off drug follow-up (up to Week 72)

10. Number of Participants With TEAEs Based on Severity

    AE was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. TEAEs are defined as AEs that developed or worsened during the treatment period. Severity of TEAEs was graded according to the following scale: Mild: Does not interfere in a significant manner with the participants normal functioning level, Moderate: Produces some impairment of functioning but is not hazardous to health and Severe: Produces significant impairment of functioning or incapacitation and is a definite hazard to the participants health.

    Time frame: From start of study drug administration up to off drug follow-up (up to Week 72)

11. Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameters

    Clinical laboratory parameters included biochemistry, hematology and urinalysis. The number of participants with clinically significant changes from baseline in laboratory parameters were reported. Clinical significance was determined by the investigator.

    Time frame: From start of study drug administration up to off drug follow-up (up to Week 72)

12. Number of Participants With Positive Treatment-emergent Anti-Drug Antibodies (ADA)

    Treatment-Emergent ADA was defined as any positive post baseline assay response when baseline results were negative or missing. Treatment-Emergent ADA responses were further classified as: Persistent (a positive result in the ADA assay detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period \[based on\] nominal sampling time\], with no ADA-negative results in-between, regardless of any missing samples); Indeterminate (a positive result in the ADA assay at the last collection time point only, regardless of any missing samples); Transient (not persistent/indeterminate, regardless of any missing samples). Number of participants with positive treatment-emergent ADA response during Week 52 were reported.

    Time frame: Baseline to Week 52

13. Number of Participants With Positive Neutralizing Antibodies (NAb)

    NAb positive was defined as presence of at least one positive nAb sample.

    Time frame: Baseline to Week 52

14. Percent Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 52

    Percent Change in fasting HDL-C from Baseline to Week 52 was reported.

    Time frame: Baseline to Week 52

15. Percent Change in Fasting Low Density Lipoprotein (LDL-C) From Baseline to Week 52

    LDL-C levels were determined in beta-quantification with ultracentrifugation method. Percent change in fasting LDL-C from Baseline to Week 52 was reported.

    Time frame: Baseline to Week 52

16. Concentration of Total Evinacumab in Serum

    Concentration of total evinacumab in serum by time at Pre-dose and End of Infusion were analyzed and reported.

    Time frame: Pre-dose and End of Infusion (EOI) at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 36, 40, 44, and 48; Pre-dose at Weeks 28 and 52

17. Concentration of Total Angiopoietin-like 3 (ANGPTL3) in Serum

    Concentration of total ANGPTL3 in serum by time were analyzed and reported.

    Time frame: Pre-dose and End of Infusion (EOI) at Weeks 0, 4, 8, 12, 16, 20, 24, 32, 36, 40, 44, and 48; Pre-dose at Weeks 28 and 52

Baseline characteristics

Study documents

• Study protocol · Dec 16, 2021
• Statistical analysis plan · Mar 21, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code