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Active Not RecruitingPhase 3NCT05852431

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

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.

Lead sponsor: 89bio, Inc.•73 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

89bio, Inc.

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

No

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)

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WITHDRAWNPhase 3

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 7, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhasePHASE3

Enrollment360

Start dateJun 2023

Last updatedAug 7, 2025

Condition

Severe Hypertriglyceridemia

Locations shown

89bio Clinical Study Site

Chandler, Arizona

89bio Clinical Study Site

Peoria, Arizona

89Bio Clinical Study Site

Tucson, Arizona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: May 16, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions