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Growth Factor

Pegozafermin Regimen 2 for Fatty Liver Disease

Q: Are there ongoing efforts to actively enroll participants for this medical study?

Indeed, the details on clinicaltrials.gov highlight that this study is currently enlisting participants. The trial was initially disclosed on March 1st, 2024, and underwent its latest revision on March 21st, 2024. To fulfill its objectives, the research team aims to recruit a total of 1050 individuals from five distinct locations.

Q: Which individuals are eligible to partake in this research investigation?

This clinical trial is currently enrolling 1050 individuals diagnosed with fatty liver disease and aged between 18 to 75 years. Eligible participants must meet specific criteria, including having a Body Mass Index (BMI) of ≥25.0 (≥23 for Asian individuals) and &#x3C;50.0 kg/m^2 at the time of screening, being male or non-pregnant female within the age range mentioned upon providing informed consent, and having biopsy-confirmed MASH with fibrosis stage F2 or F3 according to the <a href="https://www.withpower.com/clinical-trials/nash">NASH</a> CRN System along with NAS score ≥4 that includes a minimum score of 1 in

Q: Has the FDA provided approval for Pegozafermin Regimen 1?

Our evaluation at Power rates the safety of Pegozafermin Regimen 1 as a level 3 on our scale. This is due to its Phase 3 trial status, which indicates some evidence supporting effectiveness and numerous rounds of data backing its safety profile.

Q: Is there an age limit for potential participants in this study, specifically excluding those below 65 years of age?

Prospective participants must be at least 18 years old but no older than 75 to meet the trial's eligibility requirements.

Q: Are there a multitude of medical facilities conducting this research in North America?

At present, patient enrollment for this research is ongoing at 5 distinct sites. These include Wichita Falls, Little Rock, and Ocala among other locations. Opting for the nearest site to your residence can help reduce travel commitments upon enrollment.

Q: What is the total number of participants being recruited for this clinical investigation?

Indeed, as per clinicaltrials.gov, this investigation is actively seeking eligible participants. The trial was initially listed on March 1st, 2024 and underwent its latest revision on March 21st, 2024. A total of 1050 individuals are being sought across five distinct locations for enrollment in the study.

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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 36

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

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 9 mg QW

Part 1: Pegozafermin 27 mg QW

Part 1: Pegozafermin 36 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

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

776 Total Patients Enrolled

Millie Gottwald, PharmDStudy Director89bio, Inc.

3 Previous Clinical Trials

324 Total Patients Enrolled

Frequently Asked Questions

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

Are there ongoing efforts to actively enroll participants for this medical study?

"Indeed, the details on clinicaltrials.gov highlight that this study is currently enlisting participants. The trial was initially disclosed on March 1st, 2024, and underwent its latest revision on March 21st, 2024. To fulfill its objectives, the research team aims to recruit a total of 1050 individuals from five distinct locations."

Answered by AI

Which individuals are eligible to partake in this research investigation?

"This clinical trial is currently enrolling 1050 individuals diagnosed with fatty liver disease and aged between 18 to 75 years. Eligible participants must meet specific criteria, including having a Body Mass Index (BMI) of ≥25.0 (≥23 for Asian individuals) and <50.0 kg/m^2 at the time of screening, being male or non-pregnant female within the age range mentioned upon providing informed consent, and having biopsy-confirmed MASH with fibrosis stage F2 or F3 according to the NASH CRN System along with NAS score ≥4 that includes a minimum score of 1 in"

Answered by AI

Has the FDA provided approval for Pegozafermin Regimen 1?

"Our evaluation at Power rates the safety of Pegozafermin Regimen 1 as a level 3 on our scale. This is due to its Phase 3 trial status, which indicates some evidence supporting effectiveness and numerous rounds of data backing its safety profile."

Answered by AI

Is there an age limit for potential participants in this study, specifically excluding those below 65 years of age?

"Prospective participants must be at least 18 years old but no older than 75 to meet the trial's eligibility requirements."

Answered by AI

Are there a multitude of medical facilities conducting this research in North America?

"At present, patient enrollment for this research is ongoing at 5 distinct sites. These include Wichita Falls, Little Rock, and Ocala among other locations. Opting for the nearest site to your residence can help reduce travel commitments upon enrollment."

Answered by AI

What is the total number of participants being recruited for this clinical investigation?

"Indeed, as per clinicaltrials.gov, this investigation is actively seeking eligible participants. The trial was initially listed on March 1st, 2024 and underwent its latest revision on March 21st, 2024. A total of 1050 individuals are being sought across five distinct locations for enrollment in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)

2024. "A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06318169.

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