Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prev… (NCT04863014) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
Stopped: Sponsor Decision
United States, Canada, Germany21 participantsStarted 2021-07-12
Plain-language 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)
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults without FCS due to LPL loss of function mutations
. Documented history of 1 HTG-associated AP episode within 24 months of screening
. 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
. Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study
. Body mass index ≥18.0 and ≤45.0 kg/m2
. Compliance with a stable diet and exercise regimen at screening and willingness to continue the diet through the end of the study
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With at Least One Positively Adjudicated Acute Pancreatitis (AP) Episode
. Hospitalization for AP within 4 weeks of screening
. Known genetic FCS defined as homozygous or compound heterozygous LoF mutations in LPL as defined in the protocol
. Symptomatic gallstone disease within 6 months prior to screening as defined in the protocol
. 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
. Presence of any clinically significant, uncontrolled endocrine disease known to influence serum lipids as defined in the protocol
. 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