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Growth Hormone Receptor Agonist

Efruxifermin for Fatty Liver Disease

Phase 3
Recruiting
Research Sponsored by Akero Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
Must not have
Type 1 diabetes or unstable Type 2 diabetes
Any current or prior history of decompensated liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks, 5 years
Awards & highlights
Pivotal Trial

Summary

"This trial will test the effectiveness of efruxifermin in treating liver cirrhosis caused by NASH/MASH in patients at multiple medical centers. It will be a randomized study where some participants

Who is the study for?
This trial is for individuals with compensated cirrhosis caused by non-alcoholic steatohepatitis (NASH) or metabolic-associated fatty liver disease (MAFLD). Specific eligibility details are not provided, but typically participants must meet certain health criteria and not have conditions that could interfere with the study.
What is being tested?
The study is testing Efruxifermin (EFX), comparing it against a placebo in a controlled setting. Participants will be randomly assigned to either receive EFX or a placebo without knowing which one they're getting, to fairly measure the effects of the drug.
What are the potential side effects?
Potential side effects of Efruxifermin are not detailed here, but common ones for similar treatments include gastrointestinal issues, fatigue, allergic reactions, and possible impacts on blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have cirrhosis from NASH/MASH confirmed by a biopsy or non-invasive methods.
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I have cirrhosis from NASH/MASH confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Type 1 diabetes or my Type 2 diabetes is not well-controlled.
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I have had severe liver problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks, 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks, 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline of lipoproteins
Change from baseline of markers of insulin sensitivity and glycemic control
Change from baseline of markers of liver injury
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EFX 50 mgExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Akero Therapeutics, IncLead Sponsor
5 Previous Clinical Trials
2,788 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
2,088 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~767 spots leftby Sep 2029
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