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Phase III: Pegozafermin in Severe Hypertriglyceridemia (ENTRUST)

Clinical Trial Overview

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia (SHTG): The ENTRUST Study

Objective

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

FGF21: fibroblast growth factor 21
SHTG: severe hypertriglyceridemia
TG: triglycerides

Primary Endpoints

Percent change from baseline in fasting TG [Time Frame: 26 weeks]

Secondary Endpoints

Percent change from baseline in non-high-density lipoprotein cholesterol [Time Frame: 26 weeks]
Percent change from baseline in high-density lipoprotein cholesterol [Time Frame: 26 weeks]
Percent change from baseline in very low-density lipoprotein cholesterol [Time Frame: 26 weeks]
Percent change from baseline in total cholesterol [Time Frame: 26 weeks]
Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction [Time Frame: 26 weeks]
Percent change from baseline in apolipoprotein 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]

TG: triglycerides
HbA1c: hemoglobin A1C

Pegozafermin

Modality: FGF21 (fibroblast growth factor 21) Analog

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Clinical Trial Overview

Inclusion and Exclusion Criteria

Enrollment and Resources

View on ClinicalTrials.gov

Inclusion and Exclusion Criteria

Key Inclusion Criteria

Key Exclusion 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 to manage ASCVD for a minimum of 4 weeks prior to first qualifying TG

Positive for hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
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 (Type 1 hyperlipoproteinemia)

ASCVD: atherosclerotic cardiovascular disease
TG: triglycerides
HbA1c: hemoglobin A1C

Enrollment & Resources

Enrollment

For more information on eligibility criteria, view the study or reach out to our team.

Web

ClinicalTrials.gov
Identifier: NCT05852431

Phone

1-888-662-6728
(US and Canada)

Email

[email protected]

Clinical Trial Site Locations

Clinical Trial Site Locations

For more information on recruitment status, or where the study is being conducted

Visit ClinicalTrials.gov

Information is consistent with ClinicalTrials.gov as of December 17, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

Looking for more information?

Reach out to a Genentech Medical Science Liaison near you, or connect with the contact center.

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Submit a Request

Call the Trial Information Support Team: 1-888-662-6728 Hours: Monday-Friday, 5am-5pm PT

ASCVD
atherosclerotic cardiovascular disease
FGF21
fibroblast growth factor 21
HbA1c
hemoglobin A1C
SHTG
severe hypertriglyceridemia
TG
triglycerides