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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 week 52
Awards & highlights
Pivotal Trial

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.
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.
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 ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 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 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

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

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
~190

Find a Location

Who is running the clinical trial?

89bio, Inc.Lead Sponsor
6 Previous Clinical Trials
1,539 Total Patients Enrolled
Millie Gottwald, PharmDStudy Director89bio, Inc.
3 Previous Clinical Trials
324 Total Patients Enrolled
~700 spots leftby Dec 2026
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