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

Completed · Phase 3 · Has a placebo group

Conditions studied: Severe Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT05852431

Run by

89bio, Inc.

People needed

369

Starts

2023-06-15

Expected to finish

2026-04-09

Last updated by the study team

2026-07-07

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 89bio Clinical Study Site — Nagpur, India
• 89bio Clinical Study Site — Chandler, Arizona, United States
• 89bio Clinical Study Site — Peoria, Arizona, United States
• 89Bio Clinical Study Site — Tucson, Arizona, United States
• 89bio Clinical Study Site — Conway, Arkansas, United States
• 89bio Clinical Study Site — Jonesboro, Arkansas, United States
• 89bio Clinical Study Site — Little Rock, Arkansas, United States
• 89bio Clinical Trial Site — Huntington Park, California, United States
• 89Bio Clinical Study Site — Long Beach, California, United States
• 89bio Clinical Study Site — Los Angeles, California, United States
• 89bio Clinical Trial Site — Northridge, California, United States
• 89bio Clinical Trial Site — Panorama City, California, United States
• 89bio Clinical Study Site — Santa Ana, California, United States
• 89bio Clinical Trial Site — Santa Ana, California, United States
• 89bio Clinical Study Site — Thousand Oaks, California, United States
• 89Bio Clinical Study Site — Tustin, California, United States
• 89bio Clinical Study Site — Wheat Ridge, Colorado, United States
• 89bio Clinical Trial Site — Wheat Ridge, Colorado, United States
• 89bio Clinical Study Site — Bridgeport, Connecticut, United States
• 89Bio Clinical Study Site — Clearwater, Florida, United States
• 89bio Clinical Study Site — Clearwater, Florida, United States
• 89bio Clinical Study Site — Hialeah Gardens, Florida, United States
• 89bio Clinical Study Site — Belagāve, India
• 89bio Clinical Study Site — Bīkaner, India
• 89bio Clinical Study Site — Jaipur, India

Full record on ClinicalTrials.gov

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