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

NCT05852431 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: BIO89-100-2312023-503576-25-00
• Study Type: interventional
• Target: 360
• Locations: 20 countries
• Sites: 177

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.

Conditions

Severe Hypertriglyceridemia

Keywords

SHTG; Hypertriglyceridemia; Metabolic diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in fasting TG

  26 weeks

Secondary Outcomes (8)

• Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)

  26 weeks

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

  26 weeks

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

  26 weeks

• Percent change from baseline in total cholesterol (TC)

  26 weeks

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

  26 weeks

Study Arms (3)

Pegozafermin - 30mg once a week

EXPERIMENTAL

Drug: Pegozafermin

Pegozafermin - 20mg once a week

EXPERIMENTAL

Drug: Pegozafermin

Placebo once a week

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pegozafermin DRUG

Subcutaneous injection

Pegozafermin - 20mg once a week; Pegozafermin - 30mg once a week

Placebo DRUG

Subcutaneous injection

Placebo once a week

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• 89bio, Inc.: lead

Study Sites (177)

89bio Clinical Study Site

Chandler, Arizona, 85712, United States

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89bio Clinical Study Site

Peoria, Arizona, 85381, United States

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89Bio Clinical Study Site

Tucson, Arizona, 85712, United States

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89bio Clinical Study Site

Conway, Arkansas, 72032, United States

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89bio Clinical Study Site

Jonesboro, Arkansas, 72401, United States

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89bio Clinical Study Site

Little Rock, Arkansas, 72205, United States

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Huntington Park, California, 90255, United States

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Long Beach, California, 90815, United States

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Los Angeles, California, 90057, United States

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89bio Clinical Trial Site

Northridge, California, 91325, United States

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89bio Clinical Trial Site

Panorama City, California, 91402, United States

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89bio Clinical Study Site

Santa Ana, California, 92705, United States

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Santa Ana, California, 92705, United States

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89bio Clinical Study Site

Thousand Oaks, California, 91360, United States

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89Bio Clinical Study Site

Tustin, California, 92780, United States

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89bio Clinical Study Site

Wheat Ridge, Colorado, 80033, United States

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89bio Clinical Trial Site

Wheat Ridge, Colorado, 80033, United States

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Bridgeport, Connecticut, 06610, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33761, United States

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Hialeah Gardens, Florida, 33016, United States

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Homestead, Florida, 33030, United States

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Miami Lakes, Florida, 33014, United States

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Miramar, Florida, 33027, United States

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Orlando, Florida, 32825, United States

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Panama City, Florida, 32401, United States

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Port Orange, Florida, 32127, United States

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Tampa, Florida, 33606, United States

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89bio Clinical Study Site

Atlanta, Georgia, 30309, United States

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Columbus, Georgia, 31904, United States

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Lawrenceville, Georgia, 30044, United States

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Chicago, Illinois, 60607, United States

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West Des Moines, Iowa, 50265, United States

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Wichita, Kansas, 67205, United States

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Marrero, Louisiana, 70072, United States

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Shreveport, Louisiana, 71105, United States

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Oxon Hill, Maryland, 20745, United States

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Flint, Michigan, 48504, United States

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Kansas City, Missouri, 64131, United States

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89bio Clinical Study Site

St Louis, Missouri, 63110, United States

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89bio Clinical Study Site

Las Vegas, Nevada, 89106, United States

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89bio Clinical Study Site

Las Vegas, Nevada, 89118, United States

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89bio Clinical Study Sites

Sparta, New Jersey, 07871, United States

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89bio Clinical Study Site

East Syracuse, New York, 13057, United States

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New Windsor, New York, 12553, United States

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89bio Clinical Trial Site

New York, New York, 10029, United States

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North Massapequa, New York, 11758, United States

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Richmond Hill, New York, 77379, United States

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Syracuse, New York, 13057, United States

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Morganton, North Carolina, 28655, United States

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89bio Clinical Study Site

Cincinnati, Ohio, 45227, United States

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89bio Clinical Trial Site

Columbus, Ohio, 43213, United States

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89bio Clinical Study Site

Middleburg Heights, Ohio, 44130, United States

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89bio Clinical Study Site

Stow, Ohio, 44224, United States

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Oklahoma City, Oklahoma, 73102, United States

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Eugene, Oregon, 97404, United States

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Charleston, South Carolina, 29414, United States

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Chattanooga, Tennessee, 37421, United States

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89bio Clinical Trial Site

Clarksville, Tennessee, 37040, United States

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89bio Clinical Study Site

Tullahoma, Tennessee, 37388, United States

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89bio Clinical Study Site

Amarillo, Texas, 79106, United States

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89 Clinical Study Site

Austin, Texas, 78757, United States

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89bio Clinical Study Site

Dallas, Texas, 75226, United States

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89bio Clinical Study Site

Graham, Texas, 76450, United States

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89bio Clinical Study Site

Houston, Texas, 77030, United States

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Lampasas, Texas, 76550, United States

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89bio Clinical Study Site

Mansfield, Texas, 76063, United States

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89bio Clinical Trial Site

San Antonio, Texas, 78207, United States

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89bio Clinical Study Site

San Antonio, Texas, 78209, United States

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89bio Clinical Study Site

Wichita Falls, Texas, 76301, United States

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Salt Lake City, Utah, 84107, United States

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89Bio Clinical Study Site

Burke, Virginia, 22015, United States

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Richmond, Virginia, 23249, United States

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Rosario, Santa Fe Province, 2000, Argentina

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Buenos Aires, C1023AAB, Argentina

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Buenos Aires, C1425CABA, Argentina

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Buenos Aires, C1426ABP, Argentina

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Córdoba, 5000, Argentina

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89bio Clinical Study Site

Córdoba, 5749, Argentina

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Córdoba, X5000 BSQ, Argentina

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Córdoba, X5000AAX, Argentina

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Córdoba, X5004CDT, Argentina

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89bio Clinical Study Site

Mendoza, M5509, Argentina

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89bio Clinical Study Site

Rosario, S2000CVD, Argentina

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San Miguel de Tucumán, T400IHE, Argentina

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Viedma, R8500ACE, Argentina

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Graz, A-8036, Austria

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Vienna, 1030, Austria

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Vienna, 1130, Austria

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89bio Clinical Study Site

Edegem, 2650, Belgium

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89bio Clinical Study Site

Ghent, 9000, Belgium

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89bio Clinical Study Site

Haine-Saint-Paul, 7100, Belgium

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89bio Clinical Study Site

Yvoir, 5530, Belgium

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89bio Clinical Trial Site

Botevgrad, 2140, Bulgaria

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Dimitrovgrad, 6400, Bulgaria

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Plovdiv, 4004, Bulgaria

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Sliven, 8800, Bulgaria

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Sliven, 8800, Bulgaria

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Sofia, 1202, Bulgaria

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Sofia, 1336, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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Sofia, 1618, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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North Vancouver, British Columbia, V7M 2H4, Canada

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Brampton, Ontario, L6R3J7, Canada

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Chicoutimi, Quebec, G7H 7K9, Canada

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Laval, Quebec, H7T2P5, Canada

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Montreal, Quebec, H2W1R7, Canada

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Québec, Quebec, G1V 4G5, Canada

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Concepción, 4030000, Chile

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Santiago, 8330336, Chile

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Santiago, 8910259, Chile

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Valdivia, 5090000, Chile

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Viña del Mar, 2520997, Chile

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89bio Clinical Study Site

Brno, 60200, Czechia

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Brno, 65691, Czechia

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Prague, 12808, Czechia

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Prague, 14021, Czechia

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Prague, 15006, Czechia

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Marseille, 13005, France

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Paris, 75013, France

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Valenciennes, 59300, France

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Batumi, 6000, Georgia

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Kutaisi, 4600, Georgia

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Tbilisi, 0159, Georgia

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Tbilisi, 0160, Georgia

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Tbilisi, 0177, Georgia

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Tbilisi, 0186, Georgia

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Essen, 45147, Germany

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Leipzig, 27 04103, Germany

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Baja, Hungary

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89bio Clinical Trial Site

Balatonfüred, 8230, Hungary

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89bio Clinical Trial Site

Budapest, 1122, Hungary

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89bio Clinical Study Site

Nyíregyháza, 4400, Hungary

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89bio Clinical Study Site

Belagāve, 590010, India

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89bio Clinical Study Site

Bīkaner, 334001, India

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89bio Clinical Study Site

Dehradun, 248001, India

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Jaipur, 302017, India

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89bio Clinical Study Site

Nagpur, 441108, India

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89bio Clinical Study Site

Pimpri-Chinchwad, 411057, India

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89bio Clinical Study Site

Varanasi, 221010, India

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89bio Cllinical Study Site

Genova, 16132, Italy

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89bio Clinical Study Site

Milan, 20138, Italy

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Modena, 41126, Italy

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89bio Clinical Study Site

Reggio Emilia, 42123, Italy

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Daugavpils, Latvia

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89bio Clinical Trial Site

Riga, 1002, Latvia

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89bio Clinical Study Site

Zemgale, 1002, Latvia

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Monterrey, Nuevo León, 64310, Mexico

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Cuernavaca, Mexico

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89bio Clinical Study Site

General Escobedo, 66050, Mexico

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89bio Clinical Study Site

Guadalajara, 76100, Mexico

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89bio Clinical Study Site

Querétaro City, 76100, Mexico

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89bio Clinical Study Site

Tlalpan, 14080, Mexico

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89bio Clinical Study Site

Bialystok, 15-351, Poland

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89bio Clinical Study Site

Krakow, 30-348, Poland

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89bio Clinical Study Site

Krakow, 31-501, Poland

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89bio Clinical Study Site

Lodz, 91-363, Poland

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89bio Clinical Study Site

Lodz, 93-338, Poland

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89bio Clinical Study Site

Lublin, 20-362, Poland

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89bio Clinical Study Site

Warsaw, 00-215, Poland

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89Bio Clinical Study Site

San Juan, 00927, Puerto Rico

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89bio Clinical Study Site

Barcelona, 08036, Spain

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89bio Clinical Study Site

Barcelona, 08041, Spain

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89bio Clinical Study Site

Barcelona, 08907, Spain

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89bio Clinical Study Site

Cadiz, 11009, Spain

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89bio Clinical Study Site

Córdoba, 14004, Spain

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89bio Clinical Study Site

Granada, 18014, Spain

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89bio Clinical Study Site

Granada, 18016, Spain

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89bio Clinical Study Site

Huelva, 21005, Spain

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89bio Clinical Study Site

Madrid, 28041, Spain

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89bio Clinical Study Site

Málaga, 29004, Spain

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89bio Clinical Study Site

Pamplona, 31008, Spain

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89bio Clinical Study Site

Cardiff, CF14 4XW, United Kingdom

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89bio Clincal Study Site

London, N128BU, United Kingdom

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MeSH Terms

Conditions

Hypertriglyceridemia; Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Teresa Parli, MD

  89bio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: June 15, 2023
• Primary Completion: July 7, 2025
• Study Completion: April 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4); US (73); CZ (5); LA (3); PL (7); IT (4); ME (6); GE (6); DE (2); HU (4); CA (6); AR (13); IN (7); BU (12); ES (11); AU (3); PR (1); CL (5); FR (3); GB (2)