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

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 89bio, Inc.

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.