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Growth Factor

Pegozafermin for Fatty Liver Disease

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 36
Awards & highlights

Summary

This trial will investigate whether pegozafermin is effective and safe in treating liver fibrosis stage 2 or 3 in adults with a condition called MASH (previously known as nonal

Who is the study for?
Adults aged 18-75 with a BMI of ≥25 (≥23 for Asians) and <50, diagnosed with MASH (formerly NASH) having moderate to severe liver fibrosis are eligible. They must have had a recent biopsy confirming the disease stage and severity. Pregnant individuals or those outside the BMI range are excluded.Check my eligibility
What is being tested?
The trial is testing two different doses of Pegozafermin against a placebo to see if they're effective and safe in treating stages 2 or 3 liver fibrosis in adults with MASH. Participants will be randomly assigned to receive either the drug or placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for treatments like Pegozafermin may include gastrointestinal issues, potential allergic reactions, fatigue, headache, and injection site reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 36 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 With MASH/NASH Resolution Without Worsening of Fibrosis at Week 52
Proportion of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of MASH/NASH at Week 52
Secondary outcome measures
Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52
Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36
Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events

Side effects data

From 2022 Phase 1 & 2 trial • 101 Patients • NCT04048135
57%
Increased Appetite
29%
Upper Respiratory Tract Infection
14%
Gastrointestinal Infection
14%
Headache
14%
Diarrhoea
14%
Vomiting
14%
Fatigue
14%
Dizziness
14%
Cough
14%
Pulmonary Mass
14%
Hypotension
14%
Nausea
14%
Bundle Branch Block Left
14%
Constipation
100%
80%
60%
40%
20%
0%
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 2: Pegozafermin 27 mg QW
Part 1: Pegozafermin 18 mg Q2W

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Pegozafermin Regimen 2Experimental Treatment1 Intervention
Group II: Pegozafermin Regimen 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Matched Placebo will be administered in Regimens 1 and 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegozafermin
2019
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

89bio, Inc.Lead Sponsor
6 Previous Clinical Trials
1,538 Total Patients Enrolled
Millie Gottwald, PharmDStudy Director89bio, Inc.
3 Previous Clinical Trials
324 Total Patients Enrolled
~700 spots leftby Dec 2026