ENTRUST: To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia

Sponsor

89bio, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05852431

Collaborator

(none)

360

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Hypertriglyceridemia	Drug: Pegozafermin Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pegozafermin - 30mg once a week	Drug: Pegozafermin Subcutaneous injection
Experimental: Pegozafermin - 20mg once a week	Drug: Pegozafermin Subcutaneous injection
Placebo Comparator: Placebo once a week	Drug: Placebo Subcutaneous injection

Arm

Intervention/Treatment

Experimental: Pegozafermin - 30mg once a week

Drug: Pegozafermin

Subcutaneous injection

Experimental: Pegozafermin - 20mg once a week

Drug: Pegozafermin

Subcutaneous injection

Placebo Comparator: Placebo once a week

Drug: Placebo

Subcutaneous injection

Outcome Measures

Primary Outcome Measures

Percent change from baseline in fasting TG [26 weeks]

Secondary Outcome Measures

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 ≥6.5% [26 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥22 years
Willing to enter a lifestyle optimization period during the screening period and willing to maintain those eating and exercise habits for the duration of the study
Subjects should be on stable background standard-of-care Lipid Modifying Therapy (LMT)

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 (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)