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Growth Factor

Pegozafermin for Liver Cirrhosis

Phase 3

Recruiting

Research Sponsored by 89bio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-confirmed fibrosis stage F4 MASH with compensated cirrhosis

Males or non-pregnant females aged between 18 and 75 years at time of signing the informed consent form

Must not have

Liver disorder other than MASH

History or evidence of hepatic decompensation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through month 24

Awards & highlights

Summary

"This trial will test how well pegozafermin works and how safe it is for people with compensated cirrhosis caused by MASH, which is a severe form of liver disease."

Who is the study for?

Adults aged 18-75 with compensated cirrhosis due to MASH, confirmed by a liver biopsy showing stage F4 fibrosis. Participants must have a BMI of ≥25 (≥23 for Asians) and <50 kg/m² and at least one metabolic risk factor. Pregnant individuals or those not meeting the specific criteria are excluded.

What is being tested?

The trial is testing Pegozafermin's effectiveness and safety against a placebo in treating compensated cirrhosis caused by MASH. It involves administering Pegozafermin to see if it improves liver health compared to no active treatment.

What are the potential side effects?

Potential side effects of Pegozafermin may include reactions at the injection site, gastrointestinal issues, changes in blood sugar levels, and fatigue. The exact side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe liver scarring confirmed by a biopsy.

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I am between 18 and 75 years old and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver condition is not MASH.

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My liver is not working properly.

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I have or had liver cancer.

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I have type 1 diabetes or my type 2 diabetes is not well-controlled.

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I have been taking the same dose of vitamin E (>400 IU/day) for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of Participants Achieving Fibrosis Regression

Side effects data

From 2022 Phase 1 & 2 trial • 101 Patients • NCT04048135

57%

Increased Appetite

29%

Upper Respiratory Tract Infection

14%

Dizziness

14%

Hypotension

14%

Diarrhoea

14%

Nausea

14%

Vomiting

14%

Bundle Branch Block Left

14%

Constipation

14%

Fatigue

14%

Gastrointestinal Infection

14%

Headache

14%

Cough

14%

Pulmonary Mass

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: Pegozafermin 3 mg QW

Part 1: Pegozafermin 9 mg QW

Part 1: Pegozafermin 27 mg QW

Part 1: Pegozafermin 18 mg QW

Part 1: Pegozafermin 36 mg Q2W

Part 1: Placebo QW or Q2W

Part 1: Pegozafermin 18 mg Q2W

Part 2: Pegozafermin 27 mg QW

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PegozaferminExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Matched placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegozafermin

2019

Completed Phase 2

~190

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

89bio, Inc.Lead Sponsor

6 Previous Clinical Trials

1,827 Total Patients Enrolled

Maya Margalit, MDStudy Director89bio, Inc.

2 Previous Clinical Trials

135 Total Patients Enrolled

~508 spots leftby Jun 2028

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