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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
Must not have
Type 1 diabetes or uncontrolled Type 2 diabetes
Main Study Only: Weight loss > 10% in the 90 days prior to screening until randomization or from the time of collection of the liver biopsy used to assess subject eligibility until randomization, whichever is longer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 36, week 48, week 72, week 96

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.
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.
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 below
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I have cirrhosis from NASH confirmed by a biopsy.
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I am between 18 and 75 years old, not pregnant, and not breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Type 1 diabetes or my Type 2 diabetes is not under control.
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I have lost more than 10% of my weight in the last 3 months or since my liver biopsy.
Select...
I have lost more than 5% of my weight in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 36, week 48, week 72, week 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 36, week 48, week 72, week 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Main: Change from baseline in fibrosis with no worsening steatohepatitis assessed by NASH CRN system
Secondary study objectives
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 more

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

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
5 Previous Clinical Trials
3,738 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
3,038 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Efruxifermin (Recombinant Protein) Clinical Trial Eligibility Overview. Trial Name: NCT05039450 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Placebo (Cohort D), EFX 28 mg (Main Study), EFX 50 mg (Cohort D), EFX 50 mg (Main Study), Placebo (Main Study)
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Efruxifermin Highlights & Side Effects. Trial Name: NCT05039450 — Phase 2
Efruxifermin (Recombinant Protein) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05039450 — Phase 2
~46 spots leftby Dec 2025
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