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Growth Factor

EFX 50 mg for Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis (NASH)

Verified Trial
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
Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.
Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Pivotal Trial

Study Summary

This trial tests a new drug, EFX, to see if it can help treat NASH, NAFLD, and related conditions. It's a randomized, double-blind study with placebo control.

Who is the study for?
This trial is for adults aged 18-80 with a suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD, and who have at least two components of metabolic syndrome or type 2 diabetes. It's not open to those with other liver diseases, type 1 diabetes, or unstable type 2 diabetes.Check my eligibility
What is being tested?
The study tests Efruxifermin (EFX) against a placebo in a controlled setting where neither the participants nor the researchers know who receives the actual drug. The goal is to see if EFX can help people with certain types of fatty liver disease.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with treatments for liver conditions may include gastrointestinal discomfort, potential allergic reactions, fatigue, and changes in blood work reflecting liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the safety and tolerability of EFX
Secondary outcome measures
Change from baseline of body weight (kg)
Change from baseline of lipoproteins
Change from baseline of markers of glycemic control
+2 more

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: EFX 50 mg (Open-Label)Experimental Treatment1 Intervention
Group II: EFX 50 mgExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Akero Therapeutics, IncLead Sponsor
4 Previous Clinical Trials
1,438 Total Patients Enrolled

Frequently Asked Questions

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

Who is eligible to take part in this clinical experiment?

"The medical trial is looking for 600 individuals with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH) that are aged between 18 and 80."

Answered by AI

Does this research initiative require more study participants?

"Affirmative. Information on clinicaltrials.gov suggests that this medical experiment, first announced in November of 2023, is actively recruiting participants. The study requires 600 individuals to be recruited from 46 different locations."

Answered by AI

Has the FDA sanctioned EFX 50 mg for medicinal use?

"Our team's determination of EFX 50 mg being a 3 on the safety scale is based off its Phase 3 trial status, which shows evidence of not only efficacy but also multiple rounds verifying its security."

Answered by AI

What is the maximal capacity of individuals taking part in this scientific experiment?

"Affirmative. The records posted on clinicaltrials.gov verify that this research is currently enrolling participants and the original posting date was November 9th 2023, with a recent update of November 29th 2023. 600 individuals will be accepted from 46 sites nation-wide."

Answered by AI

Is the participant pool for this research restricted to adults aged 25 and over?

"The trial is seeking individuals aged 18 and up, but not exceeding 80 years of age."

Answered by AI

Are there several sites in the US currently running this research project?

"Currently, potential participants can register for this trial from 46 distinct sites. These include cities such as Los Angeles, Conway and Viera; to reduce travel requirements it is prudent to identify the closest clinic."

Answered by AI

Who else is applying?

What site did they apply to?
Akero Clinical Study Site
Tandem Clinical Research - New York, NY
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I was diagnosed with predibetes.
PatientReceived no prior treatments
~400 spots leftby Apr 2026