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Fibroblast Growth Factor 21 (FGF21) Analog

Efruxifermin for Nonalcoholic Steatohepatitis (Harmony Trial)

Verified 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
Must not have
Type 1 or uncontrolled Type 2 diabetes
Weight loss > 5% in the 3 months prior to screening until randomization or from the time of the diagnostic liver biopsy until randomization, whichever is longer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing a medication called efruxifermin to see if it can help people with a specific liver disease called NASH. The study focuses on patients whose disease has not yet progressed to cirrhosis. The medication works by reducing inflammation and fat in the liver to improve its health.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have Type 1 diabetes or my Type 2 diabetes is not under control.
Select...
I have lost more than 5% of my weight in the past 3 months or since my liver biopsy.
Select...
My liver biopsy shows I have cirrhosis.

Timeline

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

Treatment Details

Side effects data

From 2022 Phase 2 trial • 110 Patients • NCT03976401
50%
Diarrhea
45%
Nausea
30%
Injection site reaction
25%
Injection site erythema
20%
Constipation
20%
Vomiting
20%
Headache
20%
Injection site bruising
20%
Sinusitis
15%
Increased appetite
15%
Abdominal pain upper
15%
Pruritus
10%
Rash
10%
Hemorrhoidal hemorrhage
10%
Dizziness
10%
Fatigue
10%
Musculoskeletal pain
10%
Pain in extremity
10%
Upper-airway cough syndrome
5%
Hyperactive pharyngeal reflex
5%
Night sweats
5%
Defecation Urgency
5%
Injection site rash
5%
Esophageal candidiasis
5%
Food aversion
5%
Vitamin B complex deficiency
5%
Vitamin D deficiency
5%
Fibromyalgia
5%
Hypertension
5%
Edema
5%
Oropharyngeal pain
5%
Decreased appetite
5%
Abdominal distension
5%
Alopecia
5%
Skin odor abnormal
5%
Chest pain
5%
Ear infection
5%
Ligament sprain
5%
Flank pain
5%
Ageusia
5%
Abdominal Pain
5%
Dyspepsia
5%
Abdominal tenderness
5%
Abdominal discomfort
5%
Gastric disorder
5%
Injection site pruritus
5%
Early satiety
5%
Nasopharyngitis
5%
Anosmia
5%
Otitis externa
5%
Tooth abscess
5%
Hyperhidrosis
5%
Pruritus generalized
5%
Myalgia
5%
Back pain
5%
Sinus headache
5%
Cough
5%
Weight decreased
5%
Blood glucose decreased
5%
Total lung capacity decreased
5%
Fall
5%
Procedural pain
5%
Urinary retention postoperative
5%
Anxiety
5%
Angina pectoris
5%
Eyelid edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort C EFX 50 mg
Main Study EFX 70 mg
Main Study Placebo
Main Study EFX 50 mg
Cohort C Placebo
Main Study EFX 28 mg

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
5 Previous Clinical Trials
3,060 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
2,460 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
~27 spots leftby Nov 2025
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