Clinical trial NCT05852431: To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Severe Hypertriglyceridemia
Keywords: SHTG
Hypertriglyceridemia
Metabolic diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Lead sponsor: 89bio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-10
Enrollment: 360
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percent change from baseline in fasting TG
timeFrame: 26 weeks
Secondary outcomes:
measure: Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)
timeFrame: 26 weeks
measure: Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
timeFrame: 26 weeks
measure: Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C)
timeFrame: 26 weeks
measure: Percent change from baseline in total cholesterol (TC)
timeFrame: 26 weeks
measure: Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)
timeFrame: 26 weeks
measure: Percent change from baseline in apolipoprotein B (apo-B)
timeFrame: 26 weeks
measure: Change in HbA1c at Week 26 for those with baseline ≥7.0%
timeFrame: 26 weeks
measure: Percent change from baseline in fasting TG
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Peoria
country: United States
facility: 89bio Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: 89Bio Clinical Study Site
state: Arizona
city: Conway
country: United States
facility: 89bio Clinical Study Site
state: Arkansas
city: Jonesboro
country: United States
facility: 89bio Clinical Study Site
state: Arkansas
city: Little Rock
country: United States
facility: 89bio Clinical Study Site
state: Arkansas
city: Huntington Park
country: United States
facility: 89bio Clinical Trial Site
state: California
city: Long Beach
country: United States
facility: 89Bio Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: 89bio Clinical Study Site
state: California
city: Northridge
country: United States
facility: 89bio Clinical Trial Site
state: California
city: Panorama City
country: United States
facility: 89bio Clinical Trial Site
state: California
city: Santa Ana
country: United States
facility: 89bio Clinical Study Site
state: California
city: Santa Ana
country: United States
facility: 89bio Clinical Trial Site
state: California
city: Thousand Oaks
country: United States
facility: 89bio Clinical Study Site
state: California
city: Tustin
country: United States
facility: 89Bio Clinical Study Site
state: California
city: Wheat Ridge
country: United States
facility: 89bio Clinical Study Site
state: Colorado
city: Wheat Ridge
country: United States
facility: 89bio Clinical Trial Site
state: Colorado
city: Bridgeport
country: United States
facility: 89bio Clinical Study Site
state: Connecticut
city: Clearwater
country: United States
facility: 89Bio Clinical Study Site
state: Florida
city: Clearwater
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Hialeah Gardens
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Homestead
country: United States
facility: 89Bio Clinical Study Site
state: Florida
city: Miami Lakes
country: United States
facility: 89Bio Clinical Study Site
state: Florida
city: Miramar
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Orlando
country: United States
facility: 89Bio Clinical Study Site
state: Florida
city: Panama City
country: United States
facility: 89bio Clinical Study Site
state: Florida
city: Port Orange
country: United States
facility: 89bio Clinical Trial Site
state: Florida
city: Tampa
country: United States
facility: 89Bio Clinical Study Site
state: Florida
city: Atlanta
country: United States
facility: 89bio Clinical Study Site
state: Georgia
city: Columbus
country: United States
facility: 89Bio Clinical Study Site
state: Georgia
city: Lawrenceville
country: United States
facility: 89Bio Clinical Study Site
state: Georgia
city: Chicago
country: United States
facility: 89Bio Clinical Study Site
state: Illinois
city: West Des Moines
country: United States
facility: 89bio Clinical Study Site
state: Iowa
city: Wichita
country: United States
facility: 89Bio Clinical Study Site
state: Kansas
city: Marrero
country: United States
facility: 89Bio Clinical Study Site
state: Louisiana
city: Shreveport
country: United States
facility: 89bio Clinical Trial Site
state: Louisiana
city: Oxon Hill
country: United States
facility: 89Bio Clinical Study Site
state: Maryland
city: Flint
country: United States
facility: 89bio Clinical Study Site
state: Michigan
city: Kansas City
country: United States
facility: 89bio Clinical Trial Site
state: Missouri
city: Saint Louis
country: United States
facility: 89bio Clinical Study Site
state: Missouri
city: Las Vegas
country: United States
facility: 89bio Clinical Study Site
state: Nevada
city: Las Vegas
country: United States
facility: 89bio Clinical Study Site
state: Nevada
city: Sparta
country: United States
facility: 89bio Clinical Study Sites
state: New Jersey
city: East Syracuse
country: United States
facility: 89bio Clinical Study Site
state: New York
city: New Windsor
country: United States
facility: 89bio Clinical Trial Site
state: New York
city: New York
country: United States
facility: 89bio Clinical Trial Site
state: New York
city: North Massapequa
country: United States
facility: 89Bio Clinical Study Site
state: New York
city: Richmond Hill
country: United States
facility: 89bio Clinical Trial Site
state: New York
city: Syracuse
country: United States
facility: 89bio Clinical Trial Site
state: New York
city: Morganton
country: United States
facility: 89Bio Clinical Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Columbus
country: United States
facility: 89bio Clinical Trial Site
state: Ohio
city: Middleburg Heights
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Stow
country: United States
facility: 89bio Clinical Study Site
state: Ohio
city: Oklahoma City
country: United States
facility: 89bio Clinical Study Site
state: Oklahoma
city: Eugene
country: United States
facility: 89Bio Clinical Study Site
state: Oregon
city: Charleston
country: United States
facility: 89bio Clinical Study Site
state: South Carolina
city: Chattanooga
country: United States
facility: 89Bio Clinical Study Site
state: Tennessee
city: Clarksville
country: United States
facility: 89bio Clinical Trial Site
state: Tennessee
city: Tullahoma
country: United States
facility: 89bio Clinical Study Site
state: Tennessee
city: Amarillo
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Austin
country: United States
facility: 89 Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Graham
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Houston
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Lampasas
country: United States
facility: 89Bio Clinical Study Site
state: Texas
city: Mansfield
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: 89bio Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Wichita Falls
country: United States
facility: 89bio Clinical Study Site
state: Texas
city: Salt Lake City
country: United States
facility: 89bio Clinical Trial Site
state: Utah
city: Burke
country: United States
facility: 89Bio Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: 89bio Clinical Trial Site
state: Virginia
city: Rosario
country: Argentina
facility: 89bio Clinical Study Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: 89bio Clinical Study Site
city: Buenos Aires
country: Argentina
facility: 89bio Clinical Study Site
city: Buenos Aires
country: Argentina
facility: 89bio Clinical Study Site
city: Córdoba
country: Argentina
facility: 89bio Clinical Study Site
city: Córdoba
country: Argentina
facility: 89bio Clinical Study Site
city: Córdoba
country: Argentina
facility: 89bio Clinical Study Site
city: Córdoba
country: Argentina
facility: 89bio Clinical Study Site
city: Córdoba
country: Argentina
facility: 89bio Clinical Study Site
city: Mendoza
country: Argentina
facility: 89bio Clinical Study Site
city: Rosario
country: Argentina
facility: 89bio Clinical Study Site
city: San Miguel De Tucumán
country: Argentina
facility: 89bio Clinical Study Site
city: Viedma
country: Argentina
facility: 89bio Clinical Study Site
city: Graz
country: Austria
facility: 89bio Clinical Study Site
city: Vienna
country: Austria
facility: 89bio Clinical Trial Site
city: Wien
country: Austria
facility: 89bio Clinical Trial Site
city: Edegem
country: Belgium
facility: 89bio Clinical Study Site
city: Gent
country: Belgium
facility: 89bio Clinical Study Site
city: Haine-Saint-Paul
country: Belgium
facility: 89bio Clinical Study Site
city: Yvoir
country: Belgium
facility: 89bio Clinical Study Site
city: Botevgrad
country: Bulgaria
facility: 89bio Clinical Trial Site
city: Dimitrovgrad
country: Bulgaria
facility: 89bio Clinical Study Site
city: Plovdiv
country: Bulgaria
facility: 89bio Clinical Trial Site
city: Sliven
country: Bulgaria
facility: 89bio Clinical Study Site
city: Sliven
country: Bulgaria
facility: 89bio Clinical Trial Site
city: Sofia
country: Bulgaria
facility: 89bio Clinical Trial Site
city: Sofia
country: Bulgaria
facility: 89bio Clinical Study Site
city: Sofia
country: Bulgaria
facility: 89bio Clinical Study Site
city: Sofia
country: Bulgaria
facility: 89bio Clinical Study Site
city: Sofia
country: Bulgaria
facility: 89bio Clinical Study Site
city: Veliko Tarnovo
country: Bulgaria
facility: 89bio Clinical Study Site
city: Veliko Tarnovo
country: Bulgaria
facility: 89bio Clinical Trial Site
city: North Vancouver
country: Canada
facility: 89bio Clinical Study Site
state: British Columbia
city: Brampton
country: Canada
facility: 89bio Clinical Study Site
state: Ontario
city: Chicoutimi
country: Canada
facility: 89bio Clinical Study Site
state: Quebec
city: Laval
country: Canada
facility: 89bio Clinical Study Site
state: Quebec
city: Montréal
country: Canada
facility: 89bio Clinical Study Site
state: Quebec
city: Québec
country: Canada
facility: 89bio Clinical Study Site
state: Quebec
city: Concepcion
country: Chile
facility: 89bio Clinical Study Site
city: Santiago
country: Chile
facility: 89bio Clinical Study Site
city: Santiago
country: Chile
facility: 89bio Clinical Study Site
city: Valdivia
country: Chile
facility: 89bio Clinical Study Site
city: Viña Del Mar
country: Chile
facility: 89bio Clinical Study Site
city: Brno
country: Czechia
facility: 89bio Clinical Study Site
city: Brno
country: Czechia
facility: 89bio Clinical Study Site
city: Praha
country: Czechia
facility: 89bio Clinical Study Site
city: Praha
country: Czechia
facility: 89bio Clinical Study Site
city: Praha
country: Czechia
facility: 89bio Clinical Study Site
city: Marseille
country: France
facility: 89bio Clinical Study Site
city: Paris
country: France
facility: 89bio Clinical Study Site
city: Valenciennes
country: France
facility: 89bio Clinical Study Site
city: Batumi
country: Georgia
facility: 89bio Clinical Study Site
city: Kutaisi
country: Georgia
facility: 89bio Clinical Trial Site
city: Tbilisi
country: Georgia
facility: 89bio Clinical Trial Site
city: Tbilisi
country: Georgia
facility: 89bio Clinical Study Site
city: Tbilisi
country: Georgia
facility: 89bio Clinical Study Site
city: Tbilisi
country: Georgia
facility: 89bio Clinical Study Site
city: Essen
country: Germany
facility: 89bio Clinical Study Site
city: Leipzig
country: Germany
facility: 89bio Clinical Study Site
city: Baja
country: Hungary
facility: 89bio Clinical Study Site
city: Balatonfüred
country: Hungary
facility: 89bio Clinical Trial Site
city: Budapest
country: Hungary
facility: 89bio Clinical Trial Site
city: Nyiregyhaza
country: Hungary
facility: 89bio Clinical Study Site
city: Belagave
country: India
facility: 89bio Clinical Study Site
city: Bīkaner
country: India
facility: 89bio Clinical Study Site
city: Dehradun
country: India
facility: 89bio Clinical Study Site
city: Jaipur
country: India
facility: 89bio Clinical Study Site
city: Nagpur
country: India
facility: 89bio Clinical Study Site
city: Pimpri-Chinchwad
country: India
facility: 89bio Clinical Study Site
city: Varanasi
country: India
facility: 89bio Clinical Study Site
city: Genova
country: Italy
facility: 89bio Cllinical Study Site
city: Milano
country: Italy
facility: 89bio Clinical Study Site
city: Modena
country: Italy
facility: 89bio Clinical Study Site
city: Reggio Emilia
country: Italy
facility: 89bio Clinical Study Site
city: Daugavpils
country: Latvia
facility: 89bio Clinical Study Site
city: Riga
country: Latvia
facility: 89bio Clinical Trial Site
city: Zemgale
country: Latvia
facility: 89bio Clinical Study Site
city: Monterrey
country: Mexico
facility: 89bio Clinical Study Site
state: Nuevo Leon
city: Cuernavaca
country: Mexico
facility: 89bio Clinical Study Site
city: Gral Escobedo
country: Mexico
facility: 89bio Clinical Study Site
city: Guadalajara
country: Mexico
facility: 89bio Clinical Study Site
city: Santiago De Querétaro
country: Mexico
facility: 89bio Clinical Study Site
city: Tlalpan
country: Mexico
facility: 89bio Clinical Study Site
city: Białystok
country: Poland
facility: 89bio Clinical Study Site
city: Kraków
country: Poland
facility: 89bio Clinical Study Site
city: Kraków
country: Poland
facility: 89bio Clinical Study Site
city: Lublin
country: Poland
facility: 89bio Clinical Study Site
city: Warszawa
country: Poland
facility: 89bio Clinical Study Site
city: Łódź
country: Poland
facility: 89bio Clinical Study Site
city: Łódź
country: Poland
facility: 89bio Clinical Study Site
city: San Juan
country: Puerto Rico
facility: 89Bio Clinical Study Site
city: Barcelona
country: Spain
facility: 89bio Clinical Study Site
city: Barcelona
country: Spain
facility: 89bio Clinical Study Site
city: Barcelona
country: Spain
facility: 89bio Clinical Study Site
city: Cadiz
country: Spain
facility: 89bio Clinical Study Site
city: Cordoba
country: Spain
facility: 89bio Clinical Study Site
city: Granada
country: Spain
facility: 89bio Clinical Study Site
city: Granada
country: Spain
facility: 89bio Clinical Study Site
city: Huelva
country: Spain
facility: 89bio Clinical Study Site
city: Madrid
country: Spain
facility: 89bio Clinical Study Site
city: Málaga
country: Spain
facility: 89bio Clinical Study Site
city: Pamplona
country: Spain
facility: 89bio Clinical Study Site
city: Cardiff
country: United Kingdom
facility: 89bio Clinical Study Site
city: London
country: United Kingdom
facility: 89bio Clincal Study Site
Study officials:
affiliation: 89bio, Inc.
name: Teresa Parli, MD
role: STUDY_DIRECTOR
References: