Efimosfermin Alfa for Non-alcoholic Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical trial tests a new treatment called efimosfermin alfa for individuals with non-alcoholic fatty liver disease, specifically targeting those with liver damage (hepatic impairment). The study aims to understand how the body processes the drug and its safety for individuals with moderate to severe liver issues, regardless of alcohol consumption. Participants should have stable chronic liver problems due to fat buildup in the liver, with or without alcohol use, and face daily challenges from their liver condition. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that efimosfermin alfa is likely to be safe for humans?
Research has shown that efimosfermin alfa is generally safe for people with liver conditions. In earlier studies, most participants tolerated it well. These studies found that efimosfermin alfa could reduce liver fat and improve liver health over time. However, like any treatment, it may cause side effects. Some participants experienced mild issues such as headaches or fatigue, while serious side effects were rare. This safety record makes efimosfermin alfa a promising option for those considering participation in a clinical trial for liver disease treatments.12345
Why do researchers think this study treatment might be promising for fatty liver disease?
Most treatments for non-alcoholic fatty liver disease (NAFLD) focus on lifestyle changes, like diet and exercise, or managing conditions like diabetes and high cholesterol with medications. But Efimosfermin Alfa works differently, targeting Metabolic Dysfunction-Associated Steatohepatitis (MASH) directly. Researchers are excited because it offers a new approach by addressing liver inflammation and damage, regardless of alcohol use, and could potentially benefit patients with varying levels of liver impairment. This could make a big difference for people who haven’t found success with existing treatments.
What evidence suggests that efimosfermin alfa might be an effective treatment for non-alcoholic fatty liver disease?
Research shows that efimosfermin alfa, a treatment for liver disease, has promising results. Studies have found that it can greatly reduce liver fat and improve liver function in people with metabolic liver conditions. In this trial, all participants will receive efimosfermin alfa, grouped by the severity of their hepatic impairment and alcohol consumption. In clinical trials, participants experienced a decrease in signs of liver damage and scarring. Efimosfermin alfa is also generally well tolerated. These findings suggest that efimosfermin alfa may help people with liver disease improve their health.25678
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of efimosfermin alfa to evaluate pharmacokinetics and safety
Follow-up
Participants are monitored for safety and effectiveness after receiving the single dose
What Are the Treatments Tested in This Trial?
Interventions
- Efimosfermin Alfa
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
All participants will receive efimosfermin alfa. Participants will have severe hepatic impairment (Child-Pugh C) due to MASH with any typical daily alcohol consumption.
All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) with typical alcohol consumption threshold in the 3 months prior to Screening of less than (\<) 5 standard drinks on any day and \<15 standard drinks per week for men; or \<4 standard drinks on any day and \<8 standard drinks per week for women.
All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to MASH with typical alcohol consumption threshold in the 3 months prior to Screening of greater than or equal to (\>=) 5 standard drinks per day or \>=15 standard drinks per week for men; or \>= 4 standard drinks per day or \>=8 or more drinks per week for women.
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Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Citations
Efimosfermin alfa (BOS-580) once per month in people ...
Methods: This 24-week, randomised, double-blind, placebo-controlled, phase 2 trial evaluated the safety and efficacy of efimosfermin in participants aged 18-75 ...
Efimosfermin alfa (BOS-580) once per month in people ...
This 24-week, randomised, double-blind, placebo-controlled, phase 2 trial evaluated the safety and efficacy of efimosfermin in participants aged 18–75 years ...
Once-monthly efimosfermin for non-cirrhotic MASH
The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review ... Efimosfermin ...
4.
springermedicine.com
springermedicine.com/metabolic-dysfunction-associated-steatohepatitis/drug-therapy-in-internal-medicine/phase-2-data-support-further-development-of-efimosfermin-for-mas/52050792Phase 2 data support further development of efimosfermin ...
The FGF21 analog efimosfermin alfa significantly improves fibrosis regression and is well tolerated in people with metabolic ...
5.
bostonpharmaceuticals.com
bostonpharmaceuticals.com/s/2024-11-AASLD_5017_Podium_Efimosfermin-Phase-2-Part-B-Study-Results-Preliminary-Final-Amd.pdfOnce-monthly Efimosfermin Alfa (BOS-580)
In a Phase 2a study1, efimosfermin treatment resulted in statistically significant reductions in liver fat, biomarkers of liver injury and fibrosis, and.
Once-Monthly Efimosfermin Alfa for Up to 48 Weeks in MASH ...
Investigators concluded that once-monthly efimosfermin alfa was associated with fibrosis improvement and MASH resolution after up to 48 weeks in patients with ...
GSK's investigational liver therapy, efimosfermin, receives ...
Efimosfermin is an investigational, once-monthly subcutaneous injection of a long-acting variant of FGF21 that is designed to regulate key ...
A Study of Efimosfermin Alfa in Adults With Hepatic ...
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of ...
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