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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
Subcutaneous injection
Subcutaneous injection
Percent change from baseline in fasting TG
Time frame: 26 weeks
Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)
Time frame: 26 weeks
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Time frame: 26 weeks
Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C)
Time frame: 26 weeks
Percent change from baseline in total cholesterol (TC)
Time frame: 26 weeks
Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)
Time frame: 26 weeks
Percent change from baseline in apolipoprotein B (apo-B)
Time frame: 26 weeks
Change in HbA1c at Week 26 for those with baseline ≥7.0%
Time frame: 26 weeks
Percent change from baseline in fasting TG
Time frame: 52 weeks
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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
89bio Clinical Study Site
Little Rock, Arkansas, United States
89bio Clinical Trial Site
Huntington Park, California, United States
89Bio Clinical Study Site
Long Beach, California, United States
89bio Clinical Study Site
Los Angeles, California, United States
89bio Clinical Trial Site
Northridge, California, United States
...and 167 more locations