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Recombinant Protein
Efruxifermin for NASH with Cirrhosis
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
Main Study Only: Biopsy-proven compensated cirrhosis due to NASH
Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36, week 48, week 72, week 96
Awards & highlights
Study Summary
This trial is testing a new drug for people with a certain kind of liver disease. The disease is called NASH, and it's serious enough that it can cause cirrhosis.
Who is the study for?
This trial is for adults aged 18-75 with compensated cirrhosis due to NASH, which is a type of liver disease. Participants may also have Type 2 diabetes or other metabolic syndrome components like obesity. Pregnant or breastfeeding women and those with recent significant weight loss or uncontrolled diabetes are excluded.Check my eligibility
What is being tested?
The study tests Efruxifermin (EFX), comparing it against a placebo in people with advanced fatty liver disease. It's conducted at multiple centers where participants are randomly assigned to receive either the drug or placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects for EFX aren't provided here, similar medications can cause gastrointestinal issues, reactions at the injection site, changes in blood sugar levels, and potential allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have cirrhosis from NASH confirmed by a biopsy.
Select...
I am between 18 and 75 years old, not pregnant, and not breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 36, week 48, week 72, week 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36, week 48, week 72, week 96
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Main: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system
Secondary outcome measures
Cohort D: To assess the safety and tolerability of EFX compared to placebo when added to an existing GLP-1R agonist in subjects with type 2 diabetes and liver fibrosis due to NASH
Main: Change from baseline in body weight
Main: Change from baseline in fibrosis in subjects with no worsening of steatohepatitis assessed by the NASH CRN system
+6 moreSide effects data
From 2022 Phase 2 trial • 110 Patients • NCT0397640160%
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
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: EFX 50 mg (Main Study)Experimental Treatment1 Intervention
Group II: EFX 50 mg (Cohort D)Experimental Treatment1 Intervention
Group III: EFX 28 mg (Main Study)Experimental Treatment1 Intervention
Group IV: Placebo (Cohort D)Placebo Group1 Intervention
Group V: Placebo (Main Study)Placebo 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
1,838 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
238 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Type 2 diabetes or at least two symptoms of metabolic syndrome.I have cirrhosis confirmed by a liver biopsy.I have cirrhosis from NASH confirmed by a biopsy.My liver fibrosis is at stage 1, 2, or 3.I have been diagnosed with type 2 diabetes.I have been using a GLP-1R agonist medication for at least 90 days.I have Type 1 diabetes or my Type 2 diabetes is not under control.I have lost more than 10% of my weight in the last 3 months or since my liver biopsy.I have lost more than 5% of my weight in the last 3 months.I am between 18 and 75 years old, not pregnant, and not breastfeeding.I have Type 2 diabetes or at least two symptoms of metabolic syndrome.I have cirrhosis from NASH confirmed by a biopsy.I am between 18 and 75 years old, not pregnant, and not breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo (Cohort D)
- Group 2: EFX 28 mg (Main Study)
- Group 3: EFX 50 mg (Cohort D)
- Group 4: EFX 50 mg (Main Study)
- Group 5: Placebo (Main Study)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the harmful effects that have been associated with EFX?
"EFX's safety was given a score of 2 because, although there is some data supporting its safety, there is no evidence that it is an effective medication."
Answered by AI
Who meets the requirements to sign up for this experiment?
"This study is recruiting 200 patients that have non alcoholic steatohepatitis (nash) and are between 18-75 years old."
Answered by AI
In how many places is this research being conducted?
"Presently, this clinical trial is operational in 51 locations. If you are considering enrolling in the trial, be mindful of the fact that some travel may be required and try to pick a location near to you from the list of sites."
Answered by AI
Does this research project have an age limit for participants?
"Individuals aged 18 to 75 who meet the other inclusion criteria may participate in this clinical trial. There are 24 trials for people under 18 and 203 trials for senior citizens."
Answered by AI
How many people are receiving care through this clinical trial?
"The clinical trial is currently recruiting patients, as reflected on the website clinicaltrials.gov. The study was posted on 7/30/2021 and last edited on 9/8/2022; at present, they are looking for 200 participants from 51 different sites."
Answered by AI
Are people with the required health qualifications able to participate in this trial at this time?
"That is accurate. The clinical trial mentioned is, as of now, looking for participants. The original posting was on 7/30/2021 and the most recent update was 9/8/2022. A total of 200 patients are needed to be enrolled between 51 different sites."
Answered by AI
What are the team's objectives with this research?
"The primary goal of this study, which will be conducted over the course of 36 weeks, is to observe changes in fibrosis with no worsening steatohepatitis using the NASH CRN system. Additionally, this trial hopes to secondary objectives including observing the resolution of NASH with no worsening of fibrosis (determined by the NASH CRN system), Changes from baseline in lipoproteins, and change from baseline of non-invasive markers of fibrosis."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
Arizona
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Akero Clinical Study Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
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