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

August 5, 2025 updated by: 89bio, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1023AAB
        • 89bio Clinical Study Site
      • Buenos Aires, Argentina, C1425CABA
        • 89bio Clinical Study Site
      • Buenos Aires, Argentina, C1426ABP
        • 89bio Clinical Study Site
      • Córdoba, Argentina, 5000
        • 89bio Clinical Study Site
      • Córdoba, Argentina, 5749
        • 89bio Clinical Study Site
      • Córdoba, Argentina, X5000 BSQ
        • 89bio Clinical Study Site
      • Córdoba, Argentina, X5000AAX
        • 89bio Clinical Study Site
      • Córdoba, Argentina, X5004CDT
        • 89bio Clinical Study Site
      • Mendoza, Argentina, M5509
        • 89bio Clinical Study Site
      • Rosario, Argentina, S2000CVD
        • 89bio Clinical Study Site
      • San Miguel De Tucumán, Argentina, T400IHE
        • 89bio Clinical Study Site
      • Viedma, Argentina, R8500ACE
        • 89bio Clinical Study Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • 89bio Clinical Study Site
  • Austria
      • Graz, Austria, A-8036
        • 89bio Clinical Study Site
      • Vienna, Austria, 1130
        • 89bio Clinical Trial Site
      • Wien, Austria, 1030
        • 89bio Clinical Trial Site
  • Belgium
      • Edegem, Belgium, 2650
        • 89bio Clinical Study Site
      • Gent, Belgium, 9000
        • 89bio Clinical Study Site
      • Haine-Saint-Paul, Belgium, 7100
        • 89bio Clinical Study Site
      • Yvoir, Belgium, 5530
        • 89bio Clinical Study Site
  • Bulgaria
      • Botevgrad, Bulgaria, 2140
        • 89bio Clinical Trial Site
      • Dimitrovgrad, Bulgaria, 6400
        • 89bio Clinical Study Site
      • Plovdiv, Bulgaria, 4004
        • 89bio Clinical Trial Site
      • Sliven, Bulgaria, 8800
        • 89bio Clinical Study Site
      • Sliven, Bulgaria, 8800
        • 89bio Clinical Trial Site
      • Sofia, Bulgaria, 1202
        • 89bio Clinical Trial Site
      • Sofia, Bulgaria, 1336
        • 89bio Clinical Study Site
      • Sofia, Bulgaria, 1431
        • 89bio Clinical Study Site
      • Sofia, Bulgaria, 1606
        • 89bio Clinical Study Site
      • Sofia, Bulgaria, 1618
        • 89bio Clinical Study Site
      • Veliko Tarnovo, Bulgaria, 5000
        • 89bio Clinical Study Site
      • Veliko Tarnovo, Bulgaria, 5000
        • 89bio Clinical Trial Site
  • Canada
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7M 2H4
        • 89bio Clinical Study Site
    • Ontario
      • Brampton, Ontario, Canada, L6R3J7
        • 89bio Clinical Study Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • 89bio Clinical Study Site
      • Laval, Quebec, Canada, H7T2P5
        • 89bio Clinical Study Site
      • Montréal, Quebec, Canada, H2W1R7
        • 89bio Clinical Study Site
      • Québec, Quebec, Canada, G1V 4G5
        • 89bio Clinical Study Site
  • Chile
      • Concepcion, Chile, 4030000
        • 89bio Clinical Study Site
      • Santiago, Chile, 8330336
        • 89bio Clinical Study Site
      • Santiago, Chile, 8910259
        • 89bio Clinical Study Site
      • Valdivia, Chile, 5090000
        • 89bio Clinical Study Site
      • Viña Del Mar, Chile, 2520997
        • 89bio Clinical Study Site
  • Czechia
      • Brno, Czechia, 60200
        • 89bio Clinical Study Site
      • Brno, Czechia, 65691
        • 89bio Clinical Study Site
      • Praha, Czechia, 12808
        • 89bio Clinical Study Site
      • Praha, Czechia, 14021
        • 89bio Clinical Study Site
      • Praha, Czechia, 15006
        • 89bio Clinical Study Site
  • France
      • Marseille, France, 13005
        • 89bio Clinical Study Site
      • Paris, France, 75013
        • 89bio Clinical Study Site
      • Valenciennes, France, 59300
        • 89bio Clinical Study Site
  • Georgia
      • Batumi, Georgia, 6000
        • 89bio Clinical Study Site
      • Kutaisi, Georgia, 4600
        • 89bio Clinical Trial Site
      • Tbilisi, Georgia, 0159
        • 89bio Clinical Trial Site
      • Tbilisi, Georgia, 0160
        • 89bio Clinical Study Site
      • Tbilisi, Georgia, 0177
        • 89bio Clinical Study Site
      • Tbilisi, Georgia, 0186
        • 89bio Clinical Study Site
  • Germany
      • Essen, Germany, 45147
        • 89bio Clinical Study Site
      • Leipzig, Germany, 27 04103
        • 89bio Clinical Study Site
  • Hungary
      • Baja, Hungary
        • 89bio Clinical Study Site
      • Balatonfüred, Hungary, 8230
        • 89bio Clinical Trial Site
      • Budapest, Hungary, 1122
        • 89bio Clinical Trial Site
      • Nyiregyhaza, Hungary, 4400
        • 89bio Clinical Study Site
  • India
      • Belagave, India, 590010
        • 89bio Clinical Study Site
      • Bīkaner, India, 334001
        • 89bio Clinical Study Site
      • Dehradun, India, 248001
        • 89bio Clinical Study Site
      • Jaipur, India, 302017
        • 89bio Clinical Study Site
      • Nagpur, India, 441108
        • 89bio Clinical Study Site
      • Pimpri-Chinchwad, India, 411057
        • 89bio Clinical Study Site
      • Varanasi, India, 221010
        • 89bio Clinical Study Site
  • Italy
      • Genova, Italy, 16132
        • 89bio Cllinical Study Site
      • Milano, Italy, 20138
        • 89bio Clinical Study Site
      • Modena, Italy, 41126
        • 89bio Clinical Study Site
      • Reggio Emilia, Italy, 42123
        • 89bio Clinical Study Site
  • Latvia
      • Daugavpils, Latvia
        • 89bio Clinical Study Site
      • Riga, Latvia, 1002
        • 89bio Clinical Trial Site
      • Zemgale, Latvia, 1002
        • 89bio Clinical Study Site
  • Mexico
      • Cuernavaca, Mexico
        • 89bio Clinical Study Site
      • Gral Escobedo, Mexico, 66050
        • 89bio Clinical Study Site
      • Guadalajara, Mexico, 76100
        • 89bio Clinical Study Site
      • Santiago De Querétaro, Mexico, 76100
        • 89bio Clinical Study Site
      • Tlalpan, Mexico, 14080
        • 89bio Clinical Study Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64310
        • 89bio Clinical Study Site
  • Poland
      • Białystok, Poland, 15-351
        • 89bio Clinical Study Site
      • Kraków, Poland, 30-348
        • 89bio Clinical Study Site
      • Kraków, Poland, 31-501
        • 89bio Clinical Study Site
      • Lublin, Poland, 20-362
        • 89bio Clinical Study Site
      • Warszawa, Poland, 00-215
        • 89bio Clinical Study Site
      • Łódź, Poland, 91-363
        • 89bio Clinical Study Site
      • Łódź, Poland, 93-338
        • 89bio Clinical Study Site
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • 89bio Clinical Study Site
  • Spain
      • Barcelona, Spain, 08036
        • 89bio Clinical Study Site
      • Barcelona, Spain, 08041
        • 89bio Clinical Study Site
      • Barcelona, Spain, 08907
        • 89bio Clinical Study Site
      • Cadiz, Spain, 11009
        • 89bio Clinical Study Site
      • Cordoba, Spain, 14004
        • 89bio Clinical Study Site
      • Granada, Spain, 18014
        • 89bio Clinical Study Site
      • Granada, Spain, 18016
        • 89bio Clinical Study Site
      • Huelva, Spain, 21005
        • 89bio Clinical Study Site
      • Madrid, Spain, 28041
        • 89bio Clinical Study Site
      • Málaga, Spain, 29004
        • 89bio Clinical Study Site
      • Pamplona, Spain, 31008
        • 89bio Clinical Study Site
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • 89bio Clinical Study Site
      • London, United Kingdom, N128BU
        • 89bio Clincal Study Site
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85712
        • 89bio Clinical Study Site
      • Peoria, Arizona, United States, 85381
        • 89bio Clinical Study Site
      • Tucson, Arizona, United States, 85712
        • 89bio Clinical Study Site
    • Arkansas
      • Conway, Arkansas, United States, 72032
        • 89bio Clinical Study Site
      • Jonesboro, Arkansas, United States, 72401
        • 89bio Clinical Study Site
      • Little Rock, Arkansas, United States, 72205
        • 89bio Clinical Study Site
    • California
      • Huntington Park, California, United States, 90255
        • 89bio Clinical Trial Site
      • Long Beach, California, United States, 90815
        • 89bio Clinical Study Site
      • Los Angeles, California, United States, 90057
        • 89bio Clinical Study Site
      • Northridge, California, United States, 91325
        • 89bio Clinical Trial Site
      • Panorama City, California, United States, 91402
        • 89bio Clinical Trial Site
      • Santa Ana, California, United States, 92705
        • 89bio Clinical Study Site
      • Santa Ana, California, United States, 92705
        • 89bio Clinical Trial Site
      • Thousand Oaks, California, United States, 91360
        • 89bio Clinical Study Site
      • Tustin, California, United States, 92780
        • 89bio Clinical Study Site
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • 89bio Clinical Study Site
      • Wheat Ridge, Colorado, United States, 80033
        • 89bio Clinical Trial Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • 89bio Clinical Study Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • 89bio Clinical Study Site
      • Clearwater, Florida, United States, 33761
        • 89bio Clinical Study Site
      • Hialeah Gardens, Florida, United States, 33016
        • 89bio Clinical Study Site
      • Homestead, Florida, United States, 33030
        • 89bio Clinical Study Site
      • Miami Lakes, Florida, United States, 33014
        • 89bio Clinical Study Site
      • Miramar, Florida, United States, 33027
        • 89bio Clinical Study Site
      • Orlando, Florida, United States, 32825
        • 89bio Clinical Study Site
      • Panama City, Florida, United States, 32401
        • 89bio Clinical Study Site
      • Port Orange, Florida, United States, 32127
        • 89bio Clinical Trial Site
      • Tampa, Florida, United States, 33606
        • 89bio Clinical Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • 89bio Clinical Study Site
      • Columbus, Georgia, United States, 31904
        • 89bio Clinical Study Site
      • Lawrenceville, Georgia, United States, 30044
        • 89bio Clinical Study Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • 89bio Clinical Study Site
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • 89bio Clinical Study Site
    • Kansas
      • Wichita, Kansas, United States, 67205
        • 89bio Clinical Study Site
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • 89bio Clinical Study Site
      • Shreveport, Louisiana, United States, 71105
        • 89bio Clinical Trial Site
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • 89bio Clinical Study Site
    • Michigan
      • Flint, Michigan, United States, 48504
        • 89bio Clinical Study Site
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • 89bio Clinical Trial Site
      • Saint Louis, Missouri, United States, 63110
        • 89bio Clinical Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • 89bio Clinical Study Site
      • Las Vegas, Nevada, United States, 89118
        • 89bio Clinical Study Site
    • New Jersey
      • Sparta, New Jersey, United States, 07871
        • 89bio Clinical Study Sites
    • New York
      • East Syracuse, New York, United States, 13057
        • 89bio Clinical Study Site
      • New Windsor, New York, United States, 12553
        • 89bio Clinical Trial Site
      • New York, New York, United States, 10029
        • 89bio Clinical Trial Site
      • North Massapequa, New York, United States, 11758
        • 89bio Clinical Study Site
      • Richmond Hill, New York, United States, 77379
        • 89bio Clinical Trial Site
      • Syracuse, New York, United States, 13057
        • 89bio Clinical Trial Site
    • North Carolina
      • Morganton, North Carolina, United States, 28655
        • 89bio Clinical Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • 89bio Clinical Study Site
      • Columbus, Ohio, United States, 43213
        • 89bio Clinical Trial Site
      • Middleburg Heights, Ohio, United States, 44130
        • 89bio Clinical Study Site
      • Stow, Ohio, United States, 44224
        • 89bio Clinical Study Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • 89bio Clinical Study Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • 89bio Clinical Study Site
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • 89bio Clinical Study Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • 89bio Clinical Study Site
      • Clarksville, Tennessee, United States, 37040
        • 89bio Clinical Trial Site
      • Tullahoma, Tennessee, United States, 37388
        • 89bio Clinical Study Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • 89bio Clinical Study Site
      • Austin, Texas, United States, 78757
        • 89 Clinical Study Site
      • Dallas, Texas, United States, 75226
        • 89bio Clinical Study Site
      • Graham, Texas, United States, 76450
        • 89bio Clinical Study Site
      • Houston, Texas, United States, 77030
        • 89bio Clinical Study Site
      • Lampasas, Texas, United States, 76550
        • 89bio Clinical Study Site
      • Mansfield, Texas, United States, 76063
        • 89bio Clinical Study Site
      • San Antonio, Texas, United States, 78209
        • 89bio Clinical Study Site
      • San Antonio, Texas, United States, 78207
        • 89bio Clinical Trial Site
      • Wichita Falls, Texas, United States, 76301
        • 89bio Clinical Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • 89bio Clinical Trial Site
    • Virginia
      • Burke, Virginia, United States, 22015
        • 89bio Clinical Study Site
      • Richmond, Virginia, United States, 23249
        • 89bio Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in fasting TG
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)
Time Frame: 26 weeks
26 weeks
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Time Frame: 26 weeks
26 weeks
Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C)
Time Frame: 26 weeks
26 weeks
Percent change from baseline in total cholesterol (TC)
Time Frame: 26 weeks
26 weeks
Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)
Time Frame: 26 weeks
26 weeks
Percent change from baseline in apolipoprotein B (apo-B)
Time Frame: 26 weeks
26 weeks
Change in HbA1c at Week 26 for those with baseline ≥7.0%
Time Frame: 26 weeks
26 weeks
Percent change from baseline in fasting TG
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

89bio, Inc.

Investigators

  • Study Director: Teresa Parli, MD, 89bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Actual)

July 7, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO89-100-231
  • 2023-503576-25-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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