To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (ENTRUST)

89bio

Status and phase: Active, not recruiting; Phase 3

Conditions: Severe Hypertriglyceridemia

Treatments: Drug: Placebo; Drug: Pegozafermin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05852431

BIO89-100-231

2023-503576-25-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups, including a placebo group

Pegozafermin - 30mg once a week

Experimental group

Treatment:

Drug: Pegozafermin

Pegozafermin - 20mg once a week

Experimental group

Treatment:

Drug: Pegozafermin

Placebo once a week

Placebo Comparator group

Treatment:

Drug: Placebo