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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

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%

Increased Appetite

17%

Diarrhoea

Gastroenteritis

Insomnia

Hypoglycaemia

Polyuria

Frequent Bowel Movements

Gastrooesophageal Reflux Disease

Thermal Burn

Vomiting

Abdominal Distension

Change of Bowel Habit

Wrist Fracture

Abdominal Pain

Gastritis

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: Pegozafermin 9 mg QW

Part 1: Pegozafermin 3 mg QW

Part 1: Pegozafermin 36 mg Q2W

Part 1: Pegozafermin 27 mg QW

Part 1: Pegozafermin 18 mg QW

Part 1: Placebo QW or Q2W

Part 1: Pegozafermin 18 mg Q2W

Part 2: Pegozafermin 27 mg QW

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

Do I qualify?Apply below to find out

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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