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Part 1: Pegozafermin 27 mg QW for Nonalcoholic Steatohepatitis

Phase 1 & 2

Waitlist Available

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 part 1: baseline, day 92; part 2: baseline, day 141

Awards & highlights

Study Summary

This trial is testing a new drug, BIO89-100, to see if it is effective in treating NASH (a liver disease) in adults. The trial will last 12 weeks and will compare BIO89-100 to a placebo.

Eligible Conditions

Nonalcoholic Steatohepatitis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part 1: baseline, day 92; part 2: baseline, day 141

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part 1: baseline, day 92; part 2: baseline, day 141

This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1: baseline, day 92; part 2: baseline, day 141 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1: Area Under the Serum Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Pegozafermin

Part 1: Maximum Observed Serum Concentration (Cmax) of Pegozafermin

Part 1: Number of Participants With Treatment-emergent Adverse Event (TEAEs)

+4 more

Secondary outcome measures

Part 1: Number of Participants With a Positive Anti-Drug Antibodies (ADA) Response to Pegozafermin

Part 1: Percent Change From Baseline in Adiponectin at Day 92

Part 1: Percent Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR) at Day 50

+7 more

Side effects data

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

21%

Nausea

14%

Chest Pain

14%

Increased Appetite

14%

Headache

14%

Dysgeusia

Abdominal Distension

Upper Respiratory Tract Infection

Vision Blurred

Pruritus

COVID-19

Abdominal Discomfort

Vomiting

Seasonal Allergy

Diarrhoea

Neuropathy Peripheral

Alanine Aminotransferase Increased

Hyperglycaemia

Urinary Tract Infection

Dizziness

Erythema

Oropharyngeal Pain

100%

80%

60%

40%

20%

Study treatment Arm

Part 1: Pegozafermin 18 mg Q2W

Part 1: Placebo QW or Q2W

Part 1: Pegozafermin 18 mg QW

Part 2: Pegozafermin 27 mg QW

Part 1: Pegozafermin 3 mg QW

Part 1: Pegozafermin 27 mg QW

Part 1: Pegozafermin 9 mg QW

Part 1: Pegozafermin 36 mg Q2W

Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2: Pegozafermin 27 mg QWExperimental Treatment1 Intervention

Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 134.

Group II: Part 1: Pegozafermin 9 mg QWExperimental Treatment1 Intervention

Participants were administered 9 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.

Group III: Part 1: Pegozafermin 36 mg Q2WExperimental Treatment1 Intervention

Participants were administered 36 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.

Group IV: Part 1: Pegozafermin 3 milligrams (mg) weekly (QW)Experimental Treatment1 Intervention

Participants were administered 3 mg of pegozafermin QW, via subcutaneous (SC) injection, starting on Day 1 through Day 85.

Group V: Part 1: Pegozafermin 27 mg QWExperimental Treatment1 Intervention

Participants were administered 27 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.

Group VI: Part 1: Pegozafermin 18 mg QWExperimental Treatment1 Intervention

Participants were administered 18 mg of pegozafermin QW, via SC injection, starting on Day 1 through Day 85.

Group VII: Part 1: Pegozafermin 18 mg Every 2 Weeks (Q2W)Experimental Treatment1 Intervention

Participants were administered 18 mg of pegozafermin Q2W, via SC injection, starting on Day 1 through Day 85.

Group VIII: Part 1: Placebo QW or Q2WPlacebo Group1 Intervention

Participants were administered placebo matching to pegozafermin QW or Q2W, via SC injection, starting on Day 1 through Day 85.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegozafermin

2019

Completed Phase 2

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

89bio, Inc.Lead Sponsor

5 Previous Clinical Trials

1,725 Total Patients Enrolled

ProSciento, Inc.Industry Sponsor

5 Previous Clinical Trials

217 Total Patients Enrolled

ProScientoUNKNOWN

3 Previous Clinical Trials

49 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Recent research and studies

clinicaltrials.govStudy

A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH

2019. "A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04048135.

~18 spots leftby Apr 2025

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