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To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
Sponsor: 89bio, Inc.
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.
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
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2023-06-15
Completion Date
2026-04
Last Updated
2025-08-07
Healthy Volunteers
No
Conditions
Interventions
Pegozafermin
Subcutaneous injection
Placebo
Subcutaneous injection
Locations (177)
89bio Clinical Study Site
Chandler, Arizona, United States
89bio Clinical Study Site
Peoria, Arizona, United States
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Tucson, Arizona, United States
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Conway, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Huntington Park, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Panorama City, California, United States
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Santa Ana, California, United States
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Santa Ana, California, United States
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Thousand Oaks, California, United States
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Tustin, California, United States
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Wheat Ridge, Colorado, United States
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Wheat Ridge, Colorado, United States
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Bridgeport, Connecticut, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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Hialeah Gardens, Florida, United States
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Homestead, Florida, United States
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Miami Lakes, Florida, United States
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Miramar, Florida, United States
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Orlando, Florida, United States
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Panama City, Florida, United States
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Port Orange, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Lawrenceville, Georgia, United States
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Chicago, Illinois, United States
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West Des Moines, Iowa, United States
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Wichita, Kansas, United States
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Marrero, Louisiana, United States
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Shreveport, Louisiana, United States
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Oxon Hill, Maryland, United States
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Flint, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
89bio Clinical Study Sites
Sparta, New Jersey, United States
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East Syracuse, New York, United States
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New Windsor, New York, United States
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New York, New York, United States
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North Massapequa, New York, United States
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Richmond Hill, New York, United States
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Syracuse, New York, United States
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Morganton, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Middleburg Heights, Ohio, United States
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Stow, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Charleston, South Carolina, United States
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Chattanooga, Tennessee, United States
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Clarksville, Tennessee, United States
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Tullahoma, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Graham, Texas, United States
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Houston, Texas, United States
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Lampasas, Texas, United States
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Mansfield, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Salt Lake City, Utah, United States
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Burke, Virginia, United States
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Richmond, Virginia, United States
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Mendoza, Argentina
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Rosario, Argentina
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San Miguel de Tucumán, Argentina
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Viedma, Argentina
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Graz, Austria
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Vienna, Austria
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Vienna, Austria
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Edegem, Belgium
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Ghent, Belgium
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Haine-Saint-Paul, Belgium
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Yvoir, Belgium
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Botevgrad, Bulgaria
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Dimitrovgrad, Bulgaria
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Plovdiv, Bulgaria
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Sliven, Bulgaria
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Sliven, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Veliko Tarnovo, Bulgaria
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Veliko Tarnovo, Bulgaria
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North Vancouver, British Columbia, Canada
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Brampton, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Concepción, Chile
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Santiago, Chile
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Santiago, Chile
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Valdivia, Chile
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Viña del Mar, Chile
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Brno, Czechia
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Brno, Czechia
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Prague, Czechia
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Prague, Czechia
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Prague, Czechia
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Marseille, France
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Paris, France
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Valenciennes, France
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Batumi, Georgia
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Kutaisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Essen, Germany
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Leipzig, Germany
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Baja, Hungary
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Balatonfüred, Hungary
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Budapest, Hungary
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Nyíregyháza, Hungary
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Belagāve, India
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Bīkaner, India
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Dehradun, India
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Jaipur, India
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Nagpur, India
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Pimpri-Chinchwad, India
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Varanasi, India
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Genova, Italy
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Milan, Italy
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Modena, Italy
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Reggio Emilia, Italy
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Daugavpils, Latvia
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Riga, Latvia
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Zemgale, Latvia
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Monterrey, Nuevo León, Mexico
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Cuernavaca, Mexico
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General Escobedo, Mexico
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Guadalajara, Mexico
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Querétaro City, Mexico
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Tlalpan, Mexico
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Bialystok, Poland
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Krakow, Poland
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Krakow, Poland
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Lodz, Poland
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Lodz, Poland
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Lublin, Poland
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Warsaw, Poland
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San Juan, Puerto Rico
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Cadiz, Spain
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Córdoba, Spain
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Granada, Spain
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Granada, Spain
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Huelva, Spain
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Madrid, Spain
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Málaga, Spain
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Pamplona, Spain
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Cardiff, United Kingdom
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London, United Kingdom