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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

89bio Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

22 Sep 2023 → 13 Feb 2026

Decision date (initial)

2023-08-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

89bio, Inc

External identifiers

EU CT number

2023-503576-25-00

WHO UTN

U1111-1287-3725

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To determine the effect of pegozafermin on fasting serum triglyceride levels in subjects with Severe Hypertriglyceridemia after 26 weeks of treatment

Secondary objectives 2

1. To determine the effect of pegozafermin on selected serum lipids, lipoproteins, measures of glycemic control, and liver steatosis after 26 weeks of treatment and on serum TG after 52 weeks of treatment
2. To evaluate the safety and tolerability of pegozafermin when used in subjects with SHTG

Conditions and MedDRA coding

Severe Hypertriglyceridemia

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. 1. Age ≥22 years
2. 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. 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 7

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percent change from baseline in fasting TG at Week 26

Secondary endpoints 8

1. 1. Percent change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 26
2. 2. Percent change from baseline in high-density lipoprotein cholesterol (HDL-C) at Week 26
3. 3. Percent change from baseline in very low-density lipoprotein cholesterol (VLDL-C) at Week 26
4. 4. Percent change from baseline in total cholesterol (TC) at Week 26
5. 5. Percent change from baseline in fasting TG at Week 52
6. 6. Change from baseline in liver fat by magnetic resonance imaging - whole liver proton density fat fraction (MRI-PDFF) at Week 26
7. 7. Percent change from baseline in apolipoprotein B (apo-B) at Week 26
8. 8. Change in HbA1c at Week 26 for those with baseline ≥7.0%

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

89bio Inc.

Sponsor organisation

89bio Inc.

Address

655 Montgomery Street Floor 15th

City

San Francisco

Postcode

94111-2635

Country

United States

Scientific contact point

Organisation

89bio Inc.

Contact name

ENTRUST scientific

Public contact point

Organisation

89bio Inc.

Contact name

ENTRUST clinical trial

Third parties 8

Locations

11 EU/EEA countries · 54 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 288 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

31 submissions — initial application plus substantial / non-substantial modifications