1650 Participants Needed

Efruxifermin for NASH

Recruiting at 233 trial locations
AS
Overseen ByAkero Study Director
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Akero Therapeutics, Inc
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Efruxifermin for NASH?

Research shows that Efruxifermin, a drug designed to treat non-alcoholic steatohepatitis (NASH), significantly reduced liver fat in patients during clinical trials. In a study, patients receiving Efruxifermin showed a notable decrease in liver fat compared to those who received a placebo, indicating its potential effectiveness for NASH.12345

Is efruxifermin safe for humans?

Efruxifermin has been tested in several clinical trials for non-alcoholic steatohepatitis (NASH), and these studies primarily focused on its safety and tolerability. The trials generally found that efruxifermin was well-tolerated by patients, with no major safety concerns reported.12356

What makes the drug Efruxifermin unique for treating NASH?

Efruxifermin is unique because it is a fusion protein that combines a part of the human antibody with FGF21, a protein that helps regulate metabolism, and it specifically targets liver fibrosis in NASH, a condition with no approved treatments. Its mechanism involves binding to a specific receptor on cells, which is necessary for its activity, making it different from other treatments that do not use this pathway.478910

What is the purpose of this trial?

This trial is testing a medication called efruxifermin (EFX) to see if it can help people with a specific liver condition called non-cirrhotic NASH/MASH. The patients have significant liver damage but not cirrhosis. EFX aims to improve liver health by reducing swelling and scarring in the liver.

Eligibility Criteria

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.

Inclusion Criteria

FibroScan® measurement > 7.5 kPa
I have NASH confirmed by a recent biopsy showing specific liver damage.
ELF score ≥ 7.7
See 1 more

Exclusion Criteria

I have a liver condition not caused by other known diseases.
I have Type 1 diabetes or my Type 2 diabetes is not under control.
My liver biopsy shows I have cirrhosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive efruxifermin (EFX) or placebo in a randomized, double-blind, placebo-controlled study

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

188 weeks

Long-term follow-up

Participants are monitored for event-free survival and other long-term outcomes

240 weeks

Treatment Details

Interventions

  • Efruxifermin
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Akero Therapeutics, Inc

Lead Sponsor

Trials
6
Recruited
3,900+

Findings from Research

Efruxifermin, an Fc-FGF21 fusion protein, was found to significantly reduce body weight gain in rats over both 4 and 26 weeks, even with increased food intake, indicating its potential efficacy in managing weight-related issues.
Unlike some other FGF21 analogues, efruxifermin decreased urine volume without affecting electrolyte balance, and it did not increase sympathetic activation, suggesting a favorable safety profile in terms of hormonal and blood pressure responses.
Efruxifermin, a long-acting Fc-fusion FGF21 analogue, reduces body weight gain but does not increase sympathetic tone or urine volume in Sprague Dawley rats.Tillman, EJ., Brock, WJ., Rolph, T.[2022]
Efruxifermin, a long-acting Fc-FGF21 fusion protein, significantly reduced hepatic fat fraction (HFF) in patients with non-alcoholic steatohepatitis (NASH) after 12 weeks of treatment, with reductions of -12.3%, -13.4%, and -14.1% for the 28 mg, 50 mg, and 70 mg doses, respectively, compared to a negligible change of 0.3% in the placebo group.
The treatment was generally well-tolerated, with 89% of patients experiencing at least one treatment-emergent adverse event, mostly mild to moderate gastrointestinal issues, indicating an acceptable safety profile for efruxifermin.
Efruxifermin in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a trial.Harrison, SA., Ruane, PJ., Freilich, BL., et al.[2023]
In a phase 2b trial involving 128 patients with non-alcoholic steatohepatitis (NASH) and moderate to severe fibrosis, efruxifermin significantly improved liver fibrosis and resolved NASH in 39% of patients receiving 28 mg and 41% of those receiving 50 mg, compared to 20% in the placebo group.
Efruxifermin was generally well-tolerated, with most adverse events being mild to moderate, such as diarrhea and nausea, indicating its potential for further evaluation in larger phase 3 trials.
Safety and efficacy of once-weekly efruxifermin versus placebo in non-alcoholic steatohepatitis (HARMONY): a multicentre, randomised, double-blind, placebo-controlled, phase 2b trial.Harrison, SA., Frias, JP., Neff, G., et al.[2023]

References

Efruxifermin, a long-acting Fc-fusion FGF21 analogue, reduces body weight gain but does not increase sympathetic tone or urine volume in Sprague Dawley rats. [2022]
Efruxifermin in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a trial. [2023]
Safety and efficacy of once-weekly efruxifermin versus placebo in non-alcoholic steatohepatitis (HARMONY): a multicentre, randomised, double-blind, placebo-controlled, phase 2b trial. [2023]
Noncompetitive immunoassay optimized for pharmacokinetic assessments of biologically active efruxifermin. [2023]
A randomized, double-blind, placebo-controlled phase IIa trial of efruxifermin for patients with compensated NASH cirrhosis. [2023]
Aldafermin in patients with non-alcoholic steatohepatitis (ALPINE 2/3): a randomised, double-blind, placebo-controlled, phase 2b trial. [2022]
FcRn Antagonism Leads to a Decrease of Desmoglein-Specific B Cells: Secondary Analysis of a Phase 2 Study of Efgartigimod in Pemphigus Vulgaris and Pemphigus Foliaceus. [2023]
A TNFR2-Specific TNF Fusion Protein With Improved In Vivo Activity. [2022]
Development and Evaluation of a Physiologically Based Pharmacokinetic Model for Predicting the Effects of Anti-FcRn Therapy on the Disposition of Endogenous IgG in Humans. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Monoclonal antibodies directed against human FcRn and their applications. [2022]
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