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

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ClinicalTrials.gov Identifier: NCT05852431
Recruitment Status : Recruiting
First Posted : May 10, 2023
Last Update Posted : June 10, 2024
Sponsor:
Information provided by (Responsible Party):
89bio, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Severe Hypertriglyceridemia Drug: Pegozafermin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 15, 2023
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : September 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Pegozafermin - 30mg once a week Drug: Pegozafermin
Subcutaneous injection
Experimental: Pegozafermin - 20mg once a week Drug: Pegozafermin
Subcutaneous injection
Placebo Comparator: Placebo once a week Drug: Placebo
Subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Percent change from baseline in fasting TG [ Time Frame: 26 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05852431


Contacts
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Contact: ENTRUST clinical trial 415.432.9270 entrustinfo@89bio.com

Locations
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Sponsors and Collaborators
89bio, Inc.
Investigators
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Study Director: Teresa Parli, MD 89bio, Inc.
More Information
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Responsible Party: 89bio, Inc.
ClinicalTrials.gov Identifier: NCT05852431    
Other Study ID Numbers: BIO89-100-231
First Posted: May 10, 2023    Key Record Dates
Last Update Posted: June 10, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 89bio, Inc.:
SHTG
Hypertriglyceridemia
Metabolic diseases
 Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases