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

Primary Purpose

Severe Hypertriglyceridemia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pegozafermin
Placebo
Sponsored by
89bio, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Hypertriglyceridemia focused on measuring SHTG, Hypertriglyceridemia, Metabolic diseases, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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) Other inclusion and exclusion criteria may apply.

Sites / Locations

  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting
  • 89Bio Clinical Study SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Pegozafermin - 30mg once a week

Pegozafermin - 20mg once a week

Placebo once a week

Arm Description

Outcomes

Primary Outcome Measures

Percent change from baseline in fasting TG

Secondary Outcome Measures

Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C)
Percent change from baseline in total cholesterol (TC)
Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)
Percent change from baseline in apolipoprotein B (apo-B)
Change in HbA1c at Week 26 for those with baseline ≥6.5%

Full Information

First Posted
May 2, 2023
Last Updated
July 24, 2023
Sponsor
89bio, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05852431
Brief Title
To Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Severe Hypertriglyceridemia
Acronym
ENTRUST
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
89bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypertriglyceridemia
Keywords
SHTG, Hypertriglyceridemia, Metabolic diseases, Hyperlipidemias, Dyslipidemias, Lipid Metabolism Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pegozafermin - 30mg once a week
Arm Type
Experimental
Arm Title
Pegozafermin - 20mg once a week
Arm Type
Experimental
Arm Title
Placebo once a week
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pegozafermin
Intervention Description
Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
Percent change from baseline in fasting TG
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C)
Time Frame
26 weeks
Title
Percent change from baseline in high-density lipoprotein cholesterol (HDL-C)
Time Frame
26 weeks
Title
Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C)
Time Frame
26 weeks
Title
Percent change from baseline in total cholesterol (TC)
Time Frame
26 weeks
Title
Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF)
Time Frame
26 weeks
Title
Percent change from baseline in apolipoprotein B (apo-B)
Time Frame
26 weeks
Title
Change in HbA1c at Week 26 for those with baseline ≥6.5%
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) Other inclusion and exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ENTRUST clinical trial
Phone
415.432.9270
Email
entrustinfo@89bio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Parli, MD
Organizational Affiliation
89bio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
89Bio Clinical Study Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30044
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
North Massapequa
State/Province
New York
ZIP/Postal Code
11758
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Facility Name
89Bio Clinical Study Site
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator

12. IPD Sharing Statement

Plan to Share IPD
No

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

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