A PHASE 2,STUDY IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG)
Research type
Research Study
Full title
A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF SAFETY AND EFFICACY FOLLOWING REPEAT-DOSE ADMINISTRATION OF EVINACUMAB (ANTI-ANGPTL3) IN PATIENTS WITH SEVERE HYPERTRIGLYCERIDEMIA (SHTG) AT RISK FOR ACUTE PANCREATITIS
IRAS ID
239446
Contact name
Handrean Soran
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2016-003307-62
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This Study is a phase II study for patients diagnosed with severe hypertriglyceridemia (SHTG) at risk for Acute pancreatitis.
The study is randomised, placebo controlled study with up to 50 adults male and female at approximately 20 sites globally.
The study has three periods:
Screening- screening period is up to 37 days, the screening is the time when the study doctor determines eligibility to participate.
Treatment period- The treatment period is 28 weeks during which time you will receive evinacumab and placebo.
The follow up period will be approximately 20 weeks, during which time you will be monitored for safety.Patients will be reminded at visits and during phone calls to adhere to a highly effective birth control method.Pregnancy status of female patients of childbearing potential and the female partners (of childbearing potential) of male patients will be monitored throughout the study and for 24 weeks post the last dose of study drug.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0215
Date of REC Opinion
29 Jun 2018
REC opinion
Further Information Favourable Opinion