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Severe HypertriglyceridemiaPhase 3ENTRUSTNCT05852431

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

A Phase 3 study testing Pegozafermin in people with Severe Hypertriglyceridemia, run by 89bio, Inc. at 177 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Severe Hypertriglyceridemia
What is being tested?
Pegozafermin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
369 participants
Where
177 sitesin 20 countries
Study dates
15 Jun 2023to 9 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

177 sites in 20 countries.

177 sites in 20 countries

United States73 sites
  • 89bio Clinical Study Site

    Amarillo, Texas, 79106

  • 89bio Clinical Study Site

    Atlanta, Georgia, 30309

  • 89 Clinical Study Site

    Austin, Texas, 78757

  • 89bio Clinical Study Site

    Bridgeport, Connecticut, 06610

  • 89Bio Clinical Study Site

    Burke, Virginia, 22015

  • 89bio Clinical Study Site

    Chandler, Arizona, 85712

  • 89bio Clinical Study Site

    Charleston, South Carolina, 29414

  • 89Bio Clinical Study Site

    Chattanooga, Tennessee, 37421

  • 89Bio Clinical Study Site

    Chicago, Illinois, 60607

  • 89bio Clinical Study Site

    Cincinnati, Ohio, 45227

  • 89bio Clinical Trial Site

    Clarksville, Tennessee, 37040

  • 89Bio Clinical Study Site

    Clearwater, Florida, 33756

  • 89bio Clinical Study Site

    Clearwater, Florida, 33761

  • 89Bio Clinical Study Site

    Columbus, Georgia, 31904

  • 89bio Clinical Trial Site

    Columbus, Ohio, 43213

  • 89bio Clinical Study Site

    Conway, Arkansas, 72032

  • 89bio Clinical Study Site

    Dallas, Texas, 75226

  • 89bio Clinical Study Site

    East Syracuse, New York, 13057

  • 89Bio Clinical Study Site

    Eugene, Oregon, 97404

  • 89bio Clinical Study Site

    Flint, Michigan, 48504

  • 89bio Clinical Study Site

    Graham, Texas, 76450

  • 89bio Clinical Study Site

    Hialeah Gardens, Florida, 33016

  • 89Bio Clinical Study Site

    Homestead, Florida, 33030

  • 89bio Clinical Study Site

    Houston, Texas, 77030

  • 89bio Clinical Trial Site

    Huntington Park, California, 90255

  • 89bio Clinical Study Site

    Jonesboro, Arkansas, 72401

  • 89bio Clinical Trial Site

    Kansas City, Missouri, 64131

  • 89Bio Clinical Study Site

    Lampasas, Texas, 76550

  • 89bio Clinical Study Site

    Las Vegas, Nevada, 89106

  • 89bio Clinical Study Site

    Las Vegas, Nevada, 89118

  • 89Bio Clinical Study Site

    Lawrenceville, Georgia, 30044

  • 89bio Clinical Study Site

    Little Rock, Arkansas, 72205

  • 89Bio Clinical Study Site

    Long Beach, California, 90815

  • 89bio Clinical Study Site

    Los Angeles, California, 90057

  • 89bio Clinical Study Site

    Mansfield, Texas, 76063

  • 89Bio Clinical Study Site

    Marrero, Louisiana, 70072

  • 89Bio Clinical Study Site

    Miami Lakes, Florida, 33014

  • 89bio Clinical Study Site

    Middleburg Heights, Ohio, 44130

  • 89bio Clinical Study Site

    Miramar, Florida, 33027

  • 89Bio Clinical Study Site

    Morganton, North Carolina, 28655

  • 89bio Clinical Trial Site

    New Windsor, New York, 12553

  • 89bio Clinical Trial Site

    New York, New York, 10029

  • 89Bio Clinical Study Site

    North Massapequa, New York, 11758

  • 89bio Clinical Trial Site

    Northridge, California, 91325

  • 89bio Clinical Study Site

    Oklahoma City, Oklahoma, 73102

  • 89Bio Clinical Study Site

    Orlando, Florida, 32825

  • 89Bio Clinical Study Site

    Oxon Hill, Maryland, 20745

  • 89bio Clinical Study Site

    Panama City, Florida, 32401

  • 89bio Clinical Trial Site

    Panorama City, California, 91402

  • 89bio Clinical Study Site

    Peoria, Arizona, 85381

  • 89bio Clinical Trial Site

    Port Orange, Florida, 32127

  • 89bio Clinical Trial Site

    Richmond, Virginia, 23249

  • 89bio Clinical Trial Site

    Richmond Hill, New York, 77379

  • 89bio Clinical Trial Site

    Salt Lake City, Utah, 84107

  • 89bio Clinical Trial Site

    San Antonio, Texas, 78207

  • 89bio Clinical Study Site

    San Antonio, Texas, 78209

  • 89bio Clinical Study Site

    Santa Ana, California, 92705

  • 89bio Clinical Trial Site

    Santa Ana, California, 92705

  • 89bio Clinical Trial Site

    Shreveport, Louisiana, 71105

  • 89bio Clinical Study Sites

    Sparta, New Jersey, 07871

  • 89bio Clinical Study Site

    St Louis, Missouri, 63110

  • 89bio Clinical Study Site

    Stow, Ohio, 44224

  • 89bio Clinical Trial Site

    Syracuse, New York, 13057

  • 89Bio Clinical Study Site

    Tampa, Florida, 33606

  • 89bio Clinical Study Site

    Thousand Oaks, California, 91360

  • 89Bio Clinical Study Site

    Tucson, Arizona, 85712

  • 89bio Clinical Study Site

    Tullahoma, Tennessee, 37388

  • 89Bio Clinical Study Site

    Tustin, California, 92780

  • 89bio Clinical Study Site

    West Des Moines, Iowa, 50265

  • 89bio Clinical Study Site

    Wheat Ridge, Colorado, 80033

  • 89bio Clinical Trial Site

    Wheat Ridge, Colorado, 80033

  • 89Bio Clinical Study Site

    Wichita, Kansas, 67205

  • 89bio Clinical Study Site

    Wichita Falls, Texas, 76301

Other trials in United States

Argentina13 sites
  • 89bio Clinical Study Site

    Buenos Aires, C1023AAB

  • 89bio Clinical Study Site

    Buenos Aires, C1425CABA

  • 89bio Clinical Study Site

    Buenos Aires, C1426ABP

  • 89bio Clinical Study Site

    Córdoba, 5000

  • 89bio Clinical Study Site

    Córdoba, 5749

  • 89bio Clinical Study Site

    Córdoba, X5000 BSQ

  • 89bio Clinical Study Site

    Córdoba, X5000AAX

  • 89bio Clinical Study Site

    Córdoba, X5004CDT

  • 89bio Clinical Study Site

    Mendoza, M5509

  • 89bio Clinical Study Site

    Rosario, Santa Fe Province, 2000

  • 89bio Clinical Study Site

    Rosario, S2000CVD

  • 89bio Clinical Study Site

    San Miguel de Tucumán, T400IHE

  • 89bio Clinical Study Site

    Viedma, R8500ACE

Other trials in Argentina

Bulgaria12 sites
  • 89bio Clinical Trial Site

    Botevgrad, 2140

  • 89bio Clinical Study Site

    Dimitrovgrad, 6400

  • 89bio Clinical Trial Site

    Plovdiv, 4004

  • 89bio Clinical Study Site

    Sliven, 8800

  • 89bio Clinical Trial Site

    Sliven, 8800

  • 89bio Clinical Trial Site

    Sofia, 1202

  • 89bio Clinical Study Site

    Sofia, 1336

  • 89bio Clinical Study Site

    Sofia, 1431

  • 89bio Clinical Study Site

    Sofia, 1606

  • 89bio Clinical Study Site

    Sofia, 1618

  • 89bio Clinical Study Site

    Veliko Tarnovo, 5000

  • 89bio Clinical Trial Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Spain11 sites
  • 89bio Clinical Study Site

    Barcelona, 08036

  • 89bio Clinical Study Site

    Barcelona, 08041

  • 89bio Clinical Study Site

    Barcelona, 08907

  • 89bio Clinical Study Site

    Cadiz, 11009

  • 89bio Clinical Study Site

    Córdoba, 14004

  • 89bio Clinical Study Site

    Granada, 18014

  • 89bio Clinical Study Site

    Granada, 18016

  • 89bio Clinical Study Site

    Huelva, 21005

  • 89bio Clinical Study Site

    Madrid, 28041

  • 89bio Clinical Study Site

    Málaga, 29004

  • 89bio Clinical Study Site

    Pamplona, 31008

Other trials in Spain

India7 sites
  • 89bio Clinical Study Site

    Belagāve, 590010

  • 89bio Clinical Study Site

    Bīkaner, 334001

  • 89bio Clinical Study Site

    Dehradun, 248001

  • 89bio Clinical Study Site

    Jaipur, 302017

  • 89bio Clinical Study Site

    Nagpur, 441108

  • 89bio Clinical Study Site

    Pimpri-Chinchwad, 411057

  • 89bio Clinical Study Site

    Varanasi, 221010

Other trials in India

Poland7 sites
  • 89bio Clinical Study Site

    Bialystok, 15-351

  • 89bio Clinical Study Site

    Krakow, 30-348

  • 89bio Clinical Study Site

    Krakow, 31-501

  • 89bio Clinical Study Site

    Lodz, 91-363

  • 89bio Clinical Study Site

    Lodz, 93-338

  • 89bio Clinical Study Site

    Lublin, 20-362

  • 89bio Clinical Study Site

    Warsaw, 00-215

Other trials in Poland

Canada6 sites
  • 89bio Clinical Study Site

    Brampton, Ontario, L6R3J7

  • 89bio Clinical Study Site

    Chicoutimi, Quebec, G7H 7K9

  • 89bio Clinical Study Site

    Laval, Quebec, H7T2P5

  • 89bio Clinical Study Site

    Montreal, Quebec, H2W1R7

  • 89bio Clinical Study Site

    North Vancouver, British Columbia, V7M 2H4

  • 89bio Clinical Study Site

    Québec, Quebec, G1V 4G5

Other trials in Canada

Georgia6 sites
  • 89bio Clinical Study Site

    Batumi, 6000

  • 89bio Clinical Trial Site

    Kutaisi, 4600

  • 89bio Clinical Trial Site

    Tbilisi, 0159

  • 89bio Clinical Study Site

    Tbilisi, 0160

  • 89bio Clinical Study Site

    Tbilisi, 0177

  • 89bio Clinical Study Site

    Tbilisi, 0186

Other trials in Georgia

Mexico6 sites
  • 89bio Clinical Study Site

    Cuernavaca

  • 89bio Clinical Study Site

    General Escobedo, 66050

  • 89bio Clinical Study Site

    Guadalajara, 76100

  • 89bio Clinical Study Site

    Monterrey, Nuevo León, 64310

  • 89bio Clinical Study Site

    Querétaro City, 76100

  • 89bio Clinical Study Site

    Tlalpan, 14080

Other trials in Mexico

Chile5 sites
  • 89bio Clinical Study Site

    Concepción, 4030000

  • 89bio Clinical Study Site

    Santiago, 8330336

  • 89bio Clinical Study Site

    Santiago, 8910259

  • 89bio Clinical Study Site

    Valdivia, 5090000

  • 89bio Clinical Study Site

    Viña del Mar, 2520997

Other trials in Chile

Czechia5 sites
  • 89bio Clinical Study Site

    Brno, 60200

  • 89bio Clinical Study Site

    Brno, 65691

  • 89bio Clinical Study Site

    Prague, 12808

  • 89bio Clinical Study Site

    Prague, 14021

  • 89bio Clinical Study Site

    Prague, 15006

Other trials in Czechia

Belgium4 sites
  • 89bio Clinical Study Site

    Edegem, 2650

  • 89bio Clinical Study Site

    Ghent, 9000

  • 89bio Clinical Study Site

    Haine-Saint-Paul, 7100

  • 89bio Clinical Study Site

    Yvoir, 5530

Other trials in Belgium

Hungary4 sites
  • 89bio Clinical Study Site

    Baja

  • 89bio Clinical Trial Site

    Balatonfüred, 8230

  • 89bio Clinical Trial Site

    Budapest, 1122

  • 89bio Clinical Study Site

    Nyíregyháza, 4400

Other trials in Hungary

Italy4 sites
  • 89bio Cllinical Study Site

    Genova, 16132

  • 89bio Clinical Study Site

    Milan, 20138

  • 89bio Clinical Study Site

    Modena, 41126

  • 89bio Clinical Study Site

    Reggio Emilia, 42123

Other trials in Italy

Austria3 sites
  • 89bio Clinical Study Site

    Graz, A-8036

  • 89bio Clinical Trial Site

    Vienna, 1030

  • 89bio Clinical Trial Site

    Vienna, 1130

Other trials in Austria

France3 sites
  • 89bio Clinical Study Site

    Marseille, 13005

  • 89bio Clinical Study Site

    Paris, 75013

  • 89bio Clinical Study Site

    Valenciennes, 59300

Other trials in France

Latvia3 sites
  • 89bio Clinical Study Site

    Daugavpils

  • 89bio Clinical Trial Site

    Riga, 1002

  • 89bio Clinical Study Site

    Zemgale, 1002

Other trials in Latvia

Germany2 sites
  • 89bio Clinical Study Site

    Essen, 45147

  • 89bio Clinical Study Site

    Leipzig, 27 04103

Other trials in Germany

United Kingdom2 sites
  • 89bio Clinical Study Site

    Cardiff, CF14 4XW

  • 89bio Clincal Study Site

    London, N128BU

Other trials in United Kingdom

Puerto Rico1 site
  • 89Bio Clinical Study Site

    San Juan, 00927

Other trials in Puerto Rico

About this study

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

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.

Being tested
Pegozafermin, Placebo
Keywords
SHTG, Hypertriglyceridemia, Metabolic diseases, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders
Medical subject headings
Hypertriglyceridemia, Metabolic Diseases, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PegozaferminDrug

    Subcutaneous injection

  • PlaceboDrug

    Subcutaneous injection

Study groups in NCT05852431
Study groupRoleWhat they receive
Pegozafermin - 30mg once a weekExperimentalNot described
Receives: Drug: Pegozafermin
Pegozafermin - 20mg once a weekExperimentalNot described
Receives: Drug: Pegozafermin
Placebo once a weekPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in fasting TG

    Measured: 26 weeks

Secondary outcomes (8)
  1. Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)

    Measured: 26 weeks

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

    Measured: 26 weeks

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

    Measured: 26 weeks

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

    Measured: 26 weeks

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

    Measured: 26 weeks

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

    Measured: 26 weeks

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

    Measured: 26 weeks

  8. Percent change from baseline in fasting TG

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start15 Jun 2023
  3. Primary completion7 Jul 2025
  4. Study completion9 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
369 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05852431
Sponsor's protocol ID
BIO89-100-231
Other IDs
2023-503576-25-00, 2023
Acronym
ENTRUST
Status last verified
Jun 2026
First submitted
2 May 2023
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegozafermin in people with Severe Hypertriglyceridemia, run by 89bio, Inc. at 177 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, Argentina, Bulgaria, Spain, India and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change from baseline in fasting TG (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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