Last updated 4 months ago
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
360 patients around the world
Available in Puerto Rico, Spain, Chile, Argentina, United States
89bio, Inc.
1Research sites
360Patients around the world
This study is for people with
Hypertriglyceridemia
Severe Hypertriglyceridemia
Requirements for the patient
From 22 Years
All Gender
Medical requirements
- Age ≥22 years.Willing to enter a medication/lifestyle stabilization period during the screening period, which means maintaining those stable medication, eating, and exercise habits for the duration of the study.Subjects should be on stable background Lipid Modifying Therapy (LMT) to manage ASCVD for a minimum of 4 weeks prior to first qualifying TG.
- Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).Uncontrolled or newly diagnosed (≤3 months since diagnosis) Type 2 diabetes mellitus as determined by the Principal Investigator. Subjects must have HbA1c level ≤9.5% at Screening. Medications for glucose management must be stable for at least 4 weeks prior to Screening.Type 1 diabetes mellitus.A history of symptomatic gallstone disease, gallstone pancreatitis (unless treated with cholecystectomy), or any other ongoing symptomatic biliary disease.Acute pancreatitis within 6 months prior to Screening.Subjects with chronic pancreatitis.Known or suspected familial chylomicronemia syndrome (FCS) (Type 1 hyperlipoproteinemia).
Sites
STAT Research - CABA
Recruiting
StudyENTRUST
Sponsor89bio, Inc.
Conditions
Severe Hypertriglyceridemia
Requirements
From 22 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05852431
