To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
NCT ID: NCT05852431
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
360 participants
INTERVENTIONAL
2023-06-15
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Pegozafermin - 30mg once a week
Pegozafermin
Subcutaneous injection
Pegozafermin - 20mg once a week
Pegozafermin
Subcutaneous injection
Placebo once a week
Placebo
Subcutaneous injection
Interventions
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Pegozafermin
Subcutaneous injection
Placebo
Subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
22 Years
ALL
No
Sponsors
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89bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teresa Parli, MD
Role: STUDY_DIRECTOR
89bio, Inc.
Locations
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89bio Clinical Study Site
Chandler, Arizona, United States
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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
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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
89bio Clincal Study Site
London, , United Kingdom
Countries
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Other Identifiers
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2023-503576-25-00
Identifier Type: CTIS
Identifier Source: secondary_id
BIO89-100-231
Identifier Type: -
Identifier Source: org_study_id
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