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A Ph3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia: The ENTRUST study
EU CTIS ID: 2023-503576-25-00
What this study is testing
To determine the effect of pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia after 26 weeks of treatment
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Argentina
- Georgia
- Mexico
- United States
- India
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Argentina; Georgia; Mexico; United States; India and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.