Severe Hypertriglyceridemia Clinical Trial
— ENTRUSTOfficial 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.
| Status | Recruiting |
| Enrollment | 360 |
| Est. completion date | September 2026 |
| Est. primary completion date | August 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 22 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 89bio Clinical Study Site | Buenos Aires | |
| Argentina | 89bio Clinical Study Site | Buenos Aires | |
| Argentina | 89bio Clinical Study Site | Buenos Aires | |
| Argentina | 89bio Clinical Study Site | Córdoba | |
| Argentina | 89bio Clinical Study Site | Córdoba | |
| Argentina | 89bio Clinical Study Site | Córdoba | |
| Argentina | 89bio Clinical Study Site | Mendoza | |
| Argentina | 89bio Clinical Study Site | Rosario | |
| Argentina | 89bio Clinical Study Site | Rosario | Santa Fe |
| Argentina | 89bio Clinical Study Site | San Miguel De Tucumán | |
| Argentina | 89bio Clinical Study Site | Viedma | |
| Austria | 89bio Clinical Study Site | Graz | |
| Austria | 89bio Clinical Trial Site | Vienna | |
| Austria | 89bio Clinical Trial Site | Wien | |
| Belgium | 89bio Clinical Study Site | Edegem | |
| Belgium | 89bio Clinical Study Site | Gent | |
| Belgium | 89bio Clinical Study Site | Haine-Saint-Paul | |
| Belgium | 89bio Clinical Study Site | Yvoir | |
| Bulgaria | 89bio Clinical Trial Site | Botevgrad | |
| Bulgaria | 89bio Clinical Study Site | Dimitrovgrad | |
| Bulgaria | 89bio Clinical Trial Site | Plovdiv | |
| Bulgaria | 89bio Clinical Study Site | Sliven | |
| Bulgaria | 89bio Clinical Trial Site | Sliven | |
| Bulgaria | 89bio Clinical Study Site | Sofia | |
| Bulgaria | 89bio Clinical Study Site | Sofia | |
| Bulgaria | 89bio Clinical Study Site | Sofia | |
| Bulgaria | 89bio Clinical Study Site | Sofia | |
| Bulgaria | 89bio Clinical Trial Site | Sofia | |
| Bulgaria | 89bio Clinical Study Site | Veliko Tarnovo | |
| Bulgaria | 89bio Clinical Trial Site | Veliko Tarnovo | |
| Canada | 89bio Clinical Study Site | Brampton | Ontario |
| Canada | 89bio Clinical Study Site | Chicoutimi | Quebec |
| Canada | 89bio Clinical Study Site | Laval | Quebec |
| Canada | 89bio Clinical Study Site | Montréal | Quebec |
| Canada | 89bio Clinical Study Site | North Vancouver | British Columbia |
| Chile | 89bio Clinical Study Site | Concepcion | |
| Chile | 89bio Clinical Study Site | Santiago | |
| Chile | 89bio Clinical Study Site | Santiago | |
| Chile | 89bio Clinical Study Site | Viña Del Mar | |
| Czechia | 89bio Clinical Study Site | Brno | |
| Czechia | 89bio Clinical Study Site | Brno | |
| Czechia | 89bio Clinical Study Site | Praha | |
| Czechia | 89bio Clinical Study Site | Praha | |
| Czechia | 89bio Clinical Study Site | Praha | |
| France | 89bio Clinical Study Site | Marseille | |
| France | 89bio Clinical Study Site | Paris | |
| France | 89bio Clinical Study Site | Valenciennes | |
| Georgia | 89bio Clinical Study Site | Batumi | |
| Georgia | 89bio Clinical Trial Site | Kutaisi | |
| Georgia | 89bio Clinical Study Site | Tbilisi | |
| Georgia | 89bio Clinical Study Site | Tbilisi | |
| Georgia | 89bio Clinical Study Site | Tbilisi | |
| Georgia | 89bio Clinical Trial Site | Tbilisi | |
| Germany | 89bio Clinical Study Site | Essen | |
| Germany | 89bio Clinical Study Site | Leipzig | |
| Hungary | 89bio Clinical Trial Site | Balatonfüred | |
| Hungary | 89bio Clinical Trial Site | Budapest | |
| Hungary | 89bio Clinical Study Site | Nyiregyhaza | |
| Hungary | 89bio Clinical Trial Site | Puspokladany | |
| India | 89bio Clinical Study Site | Nagpur | |
| Italy | 89bio Clinical Study Site | Milano | |
| Italy | 89bio Clinical Study Site | Reggio Emilia | |
| Latvia | 89bio Clinical Study Site | Daugavpils | |
| Latvia | 89bio Clinical Trial Site | Riga | |
| Latvia | 89bio Clinical Study Site | Zemgale | |
| Poland | 89bio Clinical Study Site | Bialystok | |
| Poland | 89bio Clinical Study Site | Kraków | |
| Poland | 89bio Clinical Study Site | Kraków | |
| Poland | 89bio Clinical Study Site | Lódz | |
| Poland | 89bio Clinical Study Site | Lódz | |
| Poland | 89bio Clinical Study Site | Lublin | |
| Poland | 89bio Clinical Study Site | Warszawa | |
| Puerto Rico | 89Bio Clinical Study Site | San Juan | |
| Spain | 89bio Clinical Study Site | Barcelona | |
| Spain | 89bio Clinical Study Site | Barcelona | |
| Spain | 89bio Clinical Study Site | Barcelona | |
| Spain | 89bio Clinical Study Site | Cadiz | |
| Spain | 89bio Clinical Study Site | Cordoba | |
| Spain | 89bio Clinical Study Site | Granada | |
| Spain | 89bio Clinical Study Site | Granada | |
| Spain | 89bio Clinical Study Site | Huelva | |
| Spain | 89bio Clinical Study Site | Madrid | |
| Spain | 89bio Clinical Study Site | Málaga | |
| Spain | 89bio Clinical Study Site | Pamplona | |
| United Kingdom | 89bio Clinical Study Site | Cardiff | |
| United Kingdom | 89bio Clincal Study Site | London | |
| United States | 89bio Clinical Study Site | Amarillo | Texas |
| United States | 89bio Clinical Study Site | Atlanta | Georgia |
| United States | 89 Clinical Study Site | Austin | Texas |
| United States | 89bio Clinical Study Site | Bridgeport | Connecticut |
| United States | 89Bio Clinical Study Site | Burke | Virginia |
| United States | 89bio Clinical Study Site | Chandler | Arizona |
| United States | 89bio Clinical Study Site | Charleston | South Carolina |
| United States | 89Bio Clinical Study Site | Chattanooga | Tennessee |
| United States | 89Bio Clinical Study Site | Chicago | Illinois |
| United States | 89bio Clinical Study Site | Cincinnati | Ohio |
| United States | 89bio Clinical Trial Site | Clarksville | Tennessee |
| United States | 89Bio Clinical Study Site | Clearwater | Florida |
| United States | 89bio Clinical Study Site | Clearwater | Florida |
| United States | 89Bio Clinical Study Site | Columbus | Georgia |
| United States | 89bio Clinical Trial Site | Columbus | Ohio |
| United States | 89bio Clinical Study Site | Conway | Arkansas |
| United States | 89bio Clinical Study Site | Dallas | Texas |
| United States | 89bio Clinical Study Site | East Syracuse | New York |
| United States | 89Bio Clinical Study Site | Eugene | Oregon |
| United States | 89bio Clinical Study Site | Graham | Texas |
| United States | 89bio Clinical Study Site | Hialeah Gardens | Florida |
| United States | 89Bio Clinical Study Site | Homestead | Florida |
| United States | 89bio Clinical Study Site | Houston | Texas |
| United States | 89bio Clinical Trial Site | Huntington Park | California |
| United States | 89bio Clinical Study Site | Jonesboro | Arkansas |
| United States | 89bio Clinical Trial Site | Kansas City | Missouri |
| United States | 89bio Clinical Study Site | Kissimmee | Florida |
| United States | 89Bio Clinical Study Site | Lampasas | Texas |
| United States | 89bio Clinical Study Site | Las Vegas | Nevada |
| United States | 89bio Clinical Study Site | Las Vegas | Nevada |
| United States | 89Bio Clinical Study Site | Lawrenceville | Georgia |
| United States | 89bio Clinical Study Site | Little Rock | Arkansas |
| United States | 89Bio Clinical Study Site | Long Beach | California |
| United States | 89bio Clinical Study Site | Los Angeles | California |
| United States | 89Bio Clinical Study Site | Marrero | Louisiana |
| United States | 89Bio Clinical Study Site | Miami Lakes | Florida |
| United States | 89bio Clinical Study Site | Middleburg Heights | Ohio |
| United States | 89Bio Clinical Study Site | Morganton | North Carolina |
| United States | 89bio Clinical Trial Site | New Windsor | New York |
| United States | 89bio Clinical Trial Site | New York | New York |
| United States | 89Bio Clinical Study Site | North Massapequa | New York |
| United States | 89bio Clinical Trial Site | Northridge | California |
| United States | 89Bio Clinical Study Site | Orlando | Florida |
| United States | 89Bio Clinical Study Site | Oviedo | Florida |
| United States | 89Bio Clinical Study Site | Oxon Hill | Maryland |
| United States | 89bio Clinical Study Site | Panama City | Florida |
| United States | 89bio Clinical Trial Site | Panorama City | California |
| United States | 89bio Clinical Study Site | Peoria | Arizona |
| United States | 89bio Clinical Trial Site | Port Orange | Florida |
| United States | 89bio Clinical Trial Site | Richmond | Virginia |
| United States | 89bio Clinical Trial Site | Richmond Hill | New York |
| United States | 89bio Clinical Study Site | Saint Louis | Missouri |
| United States | 89bio Clinical Trial Site | Salt Lake City | Utah |
| United States | 89bio Clinical Study Site | San Antonio | Texas |
| United States | 89bio Clinical Trial Site | San Antonio | Texas |
| United States | 89bio Clinical Study Site | Santa Ana | California |
| United States | 89bio Clinical Trial Site | Santa Ana | California |
| United States | 89bio Clinical Trial Site | Shreveport | Louisiana |
| United States | 89bio Clinical Study Sites | Sparta | New Jersey |
| United States | 89bio Clinical Trial Site | Syracuse | New York |
| United States | 89Bio Clinical Study Site | Tampa | Florida |
| United States | 89bio Clinical Study Site | Thousand Oaks | California |
| United States | 89Bio Clinical Study Site | Tucson | Arizona |
| United States | 89bio Clinical Study Site | Tullahoma | Tennessee |
| United States | 89Bio Clinical Study Site | Tustin | California |
| United States | 89bio Clinical Study Site | West Des Moines | Iowa |
| United States | 89bio Clinical Study Site | Wheat Ridge | Colorado |
| United States | 89bio Clinical Trial Site | Wheat Ridge | Colorado |
| United States | 89Bio Clinical Study Site | Wichita | Kansas |
| United States | 89bio Clinical Study Site | Wichita Falls | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| 89bio, Inc. |
United States, Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Czechia, France, Georgia, Germany, Hungary, India, Italy, Latvia, Poland, Puerto Rico, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent change from baseline in fasting TG | 26 weeks | ||
| Secondary | Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) | 26 weeks | ||
| Secondary | Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) | 26 weeks | ||
| Secondary | Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C) | 26 weeks | ||
| Secondary | Percent change from baseline in total cholesterol (TC) | 26 weeks | ||
| Secondary | Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF) | 26 weeks | ||
| Secondary | Percent change from baseline in apolipoprotein B (apo-B) | 26 weeks | ||
| Secondary | Change in HbA1c at Week 26 for those with baseline =7.0% | 26 weeks | ||
| Secondary | Percent change from baseline in fasting TG | 52 weeks |
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