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

Phase 3

Recruiting

• Conditions: Severe Hypertriglyceridemia
• Interventions: Drug: Pegozafermin; Drug: Placebo

• Registration Number: NCT05852431
• Lead Sponsor: 89bio, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-10
• Study Start: 2023-06-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-08
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegozafermin - 30mg once a week	Pegozafermin	-
Pegozafermin - 20mg once a week	Pegozafermin	-
Placebo once a week	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in fasting TG	26 weeks

Secondary Outcome Measures

Name	Time	Method
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
Percent change from baseline in fasting TG	52 weeks
Percent change from baseline in apolipoprotein B (apo-B)	26 weeks
Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)	26 weeks
Change in HbA1c at Week 26 for those with baseline ≥7.0%	26 weeks

Trial Locations

Locations (7)

89bio Clinical Study Site; 🇬🇧 Cardiff, United Kingdom

89Bio Clinical Study Site; 🇵🇷 San Juan, Puerto Rico

89bio Clinical Trial Site; 🇱🇻 Riga, Latvia

89bio Clinical Study Sites; 🇺🇸 Sparta, New Jersey, United States

89 Clinical Study Site; 🇺🇸 Austin, Texas, United States

89bio Cllinical Study Site; 🇮🇹 Genova, Italy

89bio Clincal Study Site; 🇬🇧 London, United Kingdom