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Fibroblast Growth Factor 21 (FGF21) Analog

Efruxifermin for Nonalcoholic Steatohepatitis (Harmony Trial)

Phase 2
Waitlist Available
Research Sponsored by Akero Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have had a liver biopsy obtained ≤ 180 days prior to randomization with fibrosis stage 2 to 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components: Steatosis (scored 0 to 3), Ballooning degeneration (scored 0 to 2), and Lobular inflammation (scored 0 to 3)
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 24 weeks, 48 weeks, 96 weeks
Awards & highlights

Harmony Trial Summary

This trial is testing a new drug for NASH, a liver disease, in people who don't yet have cirrhosis. The drug will be compared to a placebo to see if it is effective.

Who is the study for?
This trial is for adults aged 18-75 with non-cirrhotic NASH, a type of fatty liver disease. Participants must have certain metabolic conditions or type 2 diabetes, and a recent biopsy showing specific levels of liver damage. Those who've lost significant weight recently or have cirrhosis or uncontrolled diabetes cannot join.Check my eligibility
What is being tested?
The study tests Efruxifermin (EFX) against a placebo in subjects with F2-F3 stage NASH. It's randomized and double-blind, meaning participants are put into the EFX or placebo group by chance and neither they nor the researchers know which one they're getting.See study design
What are the potential side effects?
While specific side effects for Efruxifermin aren't provided here, treatments like it may cause gastrointestinal issues, reactions at injection sites, potential changes in blood sugar levels, and fatigue.

Harmony Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My recent liver biopsy shows moderate fibrosis and signs of NAFLD with specific scores in steatosis, ballooning, and inflammation.
Select...
I have at least two conditions like obesity, high cholesterol, high blood pressure, or high blood sugar.

Harmony Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks, 48 weeks, 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks, 48 weeks, 96 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
Change from baseline in liver fibrosis with no worsening steatohepatitis assessed by NASH CRN system
Secondary outcome measures
Change from baseline in hepatic fat fraction
Change from baseline in liver fibrosis with no worsening of steatohepatitis assessed by the NASH CRN system
Change from baseline of body weight
+11 more

Side effects data

From 2022 Phase 2 trial • 110 Patients • NCT03976401
60%
Nausea
35%
Diarrhea
35%
Fatigue
25%
Vomiting
25%
Increased appetite
25%
Injection site erythema
20%
Abdominal Pain
20%
Frequent bowel movement
20%
Injection site reaction
15%
Decreased appetite
15%
Hypertension
15%
Headache
15%
Nasopharyngitis
15%
Upper respiratory tract infection
10%
Hypoglycemia
10%
Flatulence
10%
Chills
10%
Dyspepsia
10%
Dysphagia
10%
Pyrexia
10%
Pruritus
10%
Cough
10%
Procedural pain
5%
Eosinophilic esophagitis
5%
Pancreatitis acute
5%
Type 2 diabetes mellitus
5%
Diabetic ketoacidosis
5%
Weight decreased
5%
Acute kidney injury
5%
Mitral valve incompetence
5%
Palpitations
5%
Sinus tachycardia
5%
Anemia
5%
Splenomegaly
5%
Spinal stenosis
5%
Depressed mood
5%
Clostridium difficile colitis
5%
Diverticulitis
5%
Skin hyperpigmentation
5%
C-reactive protein increased
5%
Lumbar vertebral fracture
5%
Injection site pruritus
5%
Injection site irritation
5%
Fluid overload
5%
Scoliosis
5%
Dizziness
5%
Akathisia
5%
Abdominal pain upper
5%
Feces soft
5%
Gastroesophageal reflux disease
5%
Mucous stools
5%
Injection site bruising
5%
Feeling of body temperature change
5%
Bronchitis
5%
Gastroenteritis viral
5%
Infectious mononucleosis
5%
Injection site cellulitis
5%
Dermatitis
5%
Dyspnea
5%
Nasal congestion
5%
Pleural effusion
5%
Weight increased
5%
Blood creatine phosphokinase increased
5%
Lipase increased
5%
Anxiety
5%
Insomnia
5%
Diastolic dysfunction
5%
Tricuspid valve incompetence
5%
Left ventricular hypertrophy
5%
Neutrophilia
5%
Retracted nipples
100%
80%
60%
40%
20%
0%
Study treatment Arm
Main Study EFX 70 mg
Cohort C EFX 50 mg
Main Study Placebo
Main Study EFX 50 mg
Cohort C Placebo
Main Study EFX 28 mg

Harmony 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EFX
2019
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Akero Therapeutics, IncLead Sponsor
4 Previous Clinical Trials
1,910 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
310 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Akero Study DirectorStudy DirectorStudy Director

Media Library

Efruxifermin (Fibroblast Growth Factor 21 (FGF21) Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04767529 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: EFX 50 mg, Placebo, EFX 28 mg
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Efruxifermin Highlights & Side Effects. Trial Name: NCT04767529 — Phase 2
Efruxifermin (Fibroblast Growth Factor 21 (FGF21) Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04767529 — Phase 2

Frequently Asked Questions

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

Are individuals aged 30 or above qualified to enter this medical experiment?

"This medical trial is only open to participants aged 18 or over, with a maximum age of 75."

Answered by AI

Is this study open to recruitment at the present time?

"Unfortunately, the available evidence on clinicaltrials.gov demonstrates that this trial is no longer looking for individuals to participate in the study. The research was first posted in February 2021 and its last update occurred in June 2022. However, 234 other trials are now actively seeking patients nationwide."

Answered by AI

Are there any possible risks associated with using EFX as a treatment?

"Due to the Phase 2 status of this trial, our team has allocated a score of two indicating that there is data which supports the safety profile associated with EFX. Unfortunately, no efficacy studies have been conducted yet."

Answered by AI

Are there multiple locations in North America conducting this research endeavor?

"Currently, 46 medical centres are running this clinical trial. These sites include Charlotte, San Antonio and Greenville among many others. To limit the burden of travel associated with enrollment, it is advised that patients enroll at the nearest location to them."

Answered by AI

How can I become a participant in this trial?

"To enter this medical trial, applicants must have a diagnosis of non-alcoholic steatohepatitis (NASH) and be between 18 to 75 years old. Altogether, 128 individuals will take part in the research."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
What site did they apply to?
Akero Clinical Study Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I have history of high blood pressure, cholesterol, and obesity.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Is there compensation for this trial?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
2021. "A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04767529.
All > Autoimmune Hepatitis > Nash
~31 spots leftby Apr 2025
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