Severe Hypertriglyceridemia
Conditions
Keywords
SHTG, Hypertriglyceridemia, Metabolic diseases, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders
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.
Interventions
DRUGPegozafermin
Subcutaneous injection
DRUGPlacebo
Subcutaneous injection
Sponsors
89bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in fasting TG | 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Percent change from baseline in apolipoprotein B (apo-B) | 26 weeks |
| Change in HbA1c at Week 26 for those with baseline ≥7.0% | 26 weeks |
| Percent change from baseline in fasting TG | 52 weeks |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Czechia, France, Georgia, Germany, Hungary, India, Italy, Latvia, Mexico, Poland, Puerto Rico, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORTeresa Parli, MD
89bio, Inc.
Outcome results
None listed