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Growth Factor

EFX 28 mg for Nonalcoholic Steatohepatitis

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, 96 weeks
Awards & highlights
Pivotal Trial

Study Summary

This trial is evaluating the effectiveness of a drug called efruxifermin in treating a liver condition called non-cirrhotic NASH/MASH with fibrosis stage 2 or 3

Who is the study for?
This trial is for people with a liver condition called non-cirrhotic NASH or MASH, which involves fat buildup and fibrosis (scarring) at stage 2 or 3. Participants should not have cirrhosis, a more advanced liver scarring.Check my eligibility
What is being tested?
The study tests Efruxifermin (EFX), comparing it to a placebo in a controlled setting. Participants are randomly assigned to either the drug group or the placebo group without knowing which one they receive.See study design
What are the potential side effects?
Potential side effects of Efruxifermin may include gastrointestinal issues like nausea or diarrhea, reactions at the injection site, and possible changes in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old and if female, not pregnant or breastfeeding.
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I have at least two conditions like obesity, high cholesterol, high blood pressure, or high blood sugar.
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I have NASH confirmed by a recent biopsy showing specific liver damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks, 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks, 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change from baseline in liver fibrosis and no worsening of steatohepatitis
Change from baseline of body weight (kg)
Change from baseline of lipoproteins
+9 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 mgExperimental Treatment1 Intervention
Group II: EFX 28 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
1,038 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 new patients currently being enrolled in this ongoing clinical trial?

"Indeed, clinicaltrials.gov indicates that this particular trial is currently in the recruitment phase. The initial posting of this study was made on December 1st, 2023 and it underwent its most recent update on January 10th, 2024."

Answered by AI

For which individuals is participation in this research study deemed appropriate?

"In order to be eligible for enrollment in this research, candidates must have a diagnosis of nonalcoholic steatohepatitis and fall within the age range of 18 to 80 years. The study aims to recruit a total of one thousand individuals."

Answered by AI

What is the upper limit for the total number of individuals involved in this research investigation?

"Indeed, as per the details provided on clinicaltrials.gov, this ongoing clinical trial is actively seeking participants. The trial was initially posted on December 1st, 2023 and underwent its latest revision on January 10th, 2024. A total of 1000 individuals are required to participate in this study across a network of 66 different locations."

Answered by AI

Can individuals who are above the age of 25 be considered as potential participants in this research?

"This research study is seeking participants who are above the age of 18 but below 80 years old."

Answered by AI

At how many different venues can this clinical trial be accessed?

"At the current time, this clinical trial is being conducted at 66 distinct sites. These sites are distributed across various cities including Birmingham, North Little Rock, and Fort Myers among others. It is advisable to choose a site closest to your location in order to minimize travel obligations when enrolling in the study."

Answered by AI

Has the Food and Drug Administration given its approval for the use of EFX at a dosage of 28 milligrams?

"Based on our evaluation at Power, the safety rating for EFX 28 mg is classified as a 3. This assessment aligns with it being a Phase 3 trial where there exists evidence of effectiveness and multiple rounds of data demonstrating its safety."

Answered by AI
~667 spots leftby Dec 2026