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

Last updated: August 5, 2025
Sponsor: 89bio, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hypertriglyceridemia

Treatment

Pegozafermin

Placebo

Clinical Study ID

NCT05852431
BIO89-100-231
2023-503576-25-00
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥22 years

  • Willing to enter a medication/lifestyle stabilization period during the screeningperiod, which means maintaining those stable medication, eating, and exercise habitsfor the duration of the study

  • Subjects should be on stable background Lipid Modifying Therapy (LMT) to manageASCVD for a minimum of 4 weeks prior to first qualifying TG

Exclusion

Exclusion Criteria:

  • Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or humanimmunodeficiency virus (HIV)

  • Uncontrolled or newly diagnosed (≤3 months since diagnosis) Type 2 diabetes mellitusas determined by the Principal Investigator. Subjects must have HbA1c level ≤9.5% atScreening. Medications for glucose management must be stable for at least 4 weeksprior to Screening

  • Type 1 diabetes mellitus

  • A history of symptomatic gallstone disease, gallstone pancreatitis (unless treatedwith 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 1hyperlipoproteinemia)

Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Pegozafermin
Phase: 3
Study Start date:
June 15, 2023
Estimated Completion Date:
April 30, 2026

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  • 89bio Clinical Study Site

    Buenos Aires, C1023AAB
    Argentina

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    Córdoba, X5000AAX
    Argentina

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    Mendoza, M5509
    Argentina

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    Rosario, S2000CVD
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    San Miguel De Tucumán, T400IHE
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    Viedma, R8500ACE
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    Graz, A-8036
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    Vienna, 1130
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    Wien, 1030
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    Gent, 9000
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    Active - Recruiting

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