To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (ENTRUST)
Severe Hypertriglyceridemia
About this trial
This is an interventional treatment trial for Severe Hypertriglyceridemia focused on measuring SHTG, Hypertriglyceridemia, Metabolic diseases, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders
Eligibility Criteria
Inclusion Criteria: Age ≥22 years Willing to enter a lifestyle optimization period during the screening period and willing to maintain those eating and exercise habits for the duration of the study Subjects should be on stable background standard-of-care Lipid Modifying Therapy (LMT) Exclusion Criteria: 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 (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) Other inclusion and exclusion criteria may apply.
Sites / Locations
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
- 89Bio Clinical Study SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Pegozafermin - 30mg once a week
Pegozafermin - 20mg once a week
Placebo once a week