To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (NCT05852431) | Clinical Trial Compass
Active — Not RecruitingPhase 3
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
United States360 participantsStarted 2023-06-15
Plain-language summary
To determine the effect of Pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia (TG ≥500 to ≤2000 mg/dL) after 26 weeks of treatment.
Who can participate
Age range22 Years
SexALL
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Inclusion Criteria:
* 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
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, 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)
Other inclusion and exclusion criteria may apply.