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Monoclonal Antibodies

evinacumab for High Triglycerides

Phase 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented history of 1 HTG-associated AP episode within 24 months of screening
Stable dose of lipid-lowering therapy (≥8 weeks) and willingness to maintain a stable regimen throughout the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks
Awards & highlights

Study Summary

This trial is testing whether a drug called evinacumab can prevent recurrent episodes of acute pancreatitis in patients with elevated triglycerides.

Eligible Conditions
  • High Triglycerides

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with at least 1 positively adjudicated acute pancreatitis (AP) episode
Secondary outcome measures
Number of independently adjudicated episodes of AP per patient
Percent change in ApoB100 levels
Percent change in ApoB48
+5 more

Side effects data

From 2020 Phase 3 trial • 65 Patients • NCT03399786
16%
Nasopharyngitis
11%
Influenza like illness
9%
Headache
7%
Rhinorrhoea
5%
Toothache
2%
Urosepsis
2%
Suicide attempt
2%
Nausea
2%
Back pain
2%
Asthma
2%
Gastroenteritis viral
2%
Constipation
2%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo IV Q4W (DBTP)
Evinacumab 15 mg/kg (DBTP)
Placebo IV Q4W (OLTP)
Evinacumab 15 mg/kg (OLTP)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: evinacumabExperimental Treatment1 Intervention
Randomized 1:1
Group II: PlaceboPlacebo Group1 Intervention
Randomized 1:1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
evinacumab
2018
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
613 Previous Clinical Trials
379,438 Total Patients Enrolled
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
258 Previous Clinical Trials
250,678 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction of this medical trial limited to individuals under 25 years old?

"Prospective participants of this medical trial must be over 18 years old and under 80 to qualify."

Answered by AI

Is this trial the inaugural instance of its category?

"Research into evinacumab began in 2018, when a Regeneron-sponsored trial was conducted on 116 patients. Following this initial study and its Phase 3 approval, there are now 3 active trials being held across 14 nations and 57 cities."

Answered by AI

What potential risks come with utilizing evinacumab?

"On our safety assessment scale, evinacumab was rated a 2 as there is clinical evidence supporting its safety but not efficacy."

Answered by AI

Is this scientific experiment still recruiting participants?

"Data hosted on clinicaltrials.gov shows that this medical study is no longer accepting participants, having been initially posted on July 12th 2021 and last updated September 30th 2022. However, 102 other trials are open for recruitment at the current time."

Answered by AI

Could I qualify to join this clinical research study?

"This clinical trial is looking to enrol 21 adults aged 18-80 who have been diagnosed with hypertriglyceridemia. Eligible participants must meet the following criteria: lack of FCS due to lipoprotein lipase (LPL) loss of function mutations, documented history of one HTG-associated acute pancreatitis episode within 24 months prior to screening, fasting serum triglyceride levels higher than 880mg/dL or 500 mg/dL during the same period described in the protocol, current and stable lipid-lowering therapy for at least 8 weeks before enrollment that they are willing to maintain throughout the study duration, body mass index"

Answered by AI

Are there any medical centers running this investigation in the city?

"A plethora of medical facilities such as Saint Louis University in Saint Louis, Medical College of Wisconsin in Milwaukee, and NorthShore Medical Group in Evanston are currently participating this trial. A total of 39 sites have been identified for enrolment."

Answered by AI

Could you elaborate on the past research conducted with evinacumab?

"Currently, 3 studies are underway to study evinacumab's efficacy. Of these investigations, 2 have reached Phase 3 of the process. Clinics in 92 locations across Kharkiv and California are running trials for this medication."

Answered by AI

What is the scope of this research in regard to patient numbers?

"This clinical trial is not currently enrolling participants; it was first published on July 12th, 2021 and its most recent entry is from September 30th 2022. If you are searching for other trials targeting hypertriglyceridemia, there are 99 studies in progress while evinacumab can be found in 3 active trials."

Answered by AI
~6 spots leftby Mar 2025