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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
Pivotal Trial

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants Achieving Fibrosis Regression

Side effects data

From 2022 Phase 1 & 2 trial • 101 Patients • NCT04048135
17%
Abdominal Tenderness
17%
Diarrhoea
17%
Increased Appetite
8%
Wrist Fracture
8%
Insomnia
8%
Abdominal Distension
8%
Gastritis
8%
Gastrooesophageal Reflux Disease
8%
Abdominal Pain
8%
Gastroenteritis
8%
Polyuria
8%
Hypoglycaemia
8%
Frequent Bowel Movements
8%
Change of Bowel Habit
8%
Thermal Burn
8%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Pegozafermin 9 mg QW
Part 2: Pegozafermin 27 mg QW
Part 1: Pegozafermin 3 mg QW
Part 1: Placebo QW or Q2W
Part 1: Pegozafermin 27 mg QW
Part 1: Pegozafermin 18 mg Q2W
Part 1: Pegozafermin 36 mg Q2W
Part 1: Pegozafermin 18 mg QW

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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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