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Completed

NCT Number: NCT05852431

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.

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Key information

Conditions

Severe Hypertriglyceridemia Dyslipidemias Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

89bio Clinical Study Site, Rosario, Santa Fe Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pegozafermin

Drug

Subcutaneous injection

Placebo

Drug

Subcutaneous injection

Primary outcomes

  1. Percent change from baseline in fasting TG

    Time frame: 26 weeks

Secondary outcomes

  1. Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)

    Time frame: 26 weeks

  2. Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)

    Time frame: 26 weeks

  3. Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C)

    Time frame: 26 weeks

  4. Percent change from baseline in total cholesterol (TC)

    Time frame: 26 weeks

  5. Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)

    Time frame: 26 weeks

  6. Percent change from baseline in apolipoprotein B (apo-B)

    Time frame: 26 weeks

  7. Change in HbA1c at Week 26 for those with baseline ≥7.0%

    Time frame: 26 weeks

  8. Percent change from baseline in fasting TG

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

89bio, Inc.

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (SHTG): The ENTRUST Study

Acronym: ENTRUST

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 10, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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