A Ph3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia: The ENTRUST study

Phase 1

Recruiting

• Conditions: Severe Hypertriglyceridemia; MedDRA version: 20.1Level: LLTClassification code: 10020870Term: Hypertriglyceridemia Class: 10027433; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-503576-25-00
• Lead Sponsor: 89bio Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

1. Age =22 years, 2. 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, 3. 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

1. Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV), 2. 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, 3. Type 1 diabetes mellitus, 4. A history of symptomatic gallstone disease, gallstone pancreatitis (unless treated with cholecystectomy), or any other ongoing symptomatic biliary disease, 5. Acute pancreatitis within 6 months prior to Screening, 6. Subjects with chronic pancreatitis, 7. Known or suspected familial chylomicronemia syndrome (FCS) (Type 1 hyperlipoproteinemia)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified