Efimosfermin Alfa for Nonalcoholic Steatohepatitis
(ZENITH-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Efimosfermin Alfa to determine its safety and effectiveness for individuals with nonalcoholic steatohepatitis (NASH), a condition involving liver inflammation and fat buildup. Participants will be randomly assigned to receive one of two doses of Efimosfermin Alfa or a placebo, which contains no active drug. The trial seeks individuals with NASH who also meet at least two criteria of metabolic syndrome, such as high blood pressure or high blood sugar. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Efimosfermin Alfa is generally safe for people with nonalcoholic steatohepatitis, a liver condition. Studies found that most participants did not experience serious side effects, indicating a good safety profile. The treatment also improved liver health by reducing liver fat and damage markers. While no treatment is completely without risk, evidence from previous studies suggests that Efimosfermin Alfa is relatively safe.12345
Why do researchers think this study treatment might be promising for MASH?
Researchers are excited about Efimosfermin Alfa for treating Nonalcoholic Steatohepatitis (NASH) because it offers a novel approach compared to current treatments like lifestyle changes and medications that target metabolism or inflammation. Unlike these standard treatments, Efimosfermin Alfa works by enhancing mitochondrial function, which plays a crucial role in energy production and cellular health. This unique mechanism could address the root causes of NASH more effectively, potentially leading to better outcomes for patients. Additionally, the trial includes different dose levels of Efimosfermin Alfa, allowing researchers to identify the most effective dosing strategy.
What evidence suggests that Efimosfermin Alfa might be an effective treatment for MASH?
Studies have shown that Efimosfermin Alfa holds promise for treating nonalcoholic steatohepatitis (NASH). Research indicates that Efimosfermin Alfa, a protein known as FGF21, reduces liver fat and improves liver health. Specifically, previous patients experienced significant reductions in liver fat and signs of liver damage. This suggests it could enhance liver function and possibly reverse some damage. Overall, the treatment has proven safe, offering hope for those with NASH. Participants in this trial will receive either Efimosfermin Alfa at one of two dose levels or a placebo, determined randomly.12345
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
This trial is for adults aged 18 to 75 with known or suspected MASH (a type of liver disease) at stage F2 or F3. Participants should have two or more components of metabolic syndrome, as defined by the American Heart Association, and must be able to understand and sign a consent form.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Efimosfermin Alfa or placebo for the duration of the study
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Efimosfermin Alfa
Trial Overview
The study tests Efimosfermin Alfa's safety and tolerability against a placebo in individuals with MASH that has progressed to fibrosis stages F2 or F3. It aims to see how well patients handle the drug compared to not receiving it.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants randomized to this group will receive Efimosfermin Alfa at dose level 2
Participants randomized to this group will receive Efimosfermin Alfa at dose level 1
Participants randomized to this group will receive Placebo
Find a Clinic Near You
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), a long-acting FGF21 ...
Interpretation. In participants with phenotypic MASH, efimosfermin had a favourable safety profile and showed improvements in indicators of hepatic steatosis.
Efimosfermin alfa (BOS-580), a long-acting FGF21 ...
In participants with phenotypic MASH, efimosfermin had a favourable safety profile and showed improvements in indicators of hepatic steatosis.
Boston Pharmaceuticals to Announce Positive Phase 2 ...
In clinical studies, efimosfermin has previously demonstrated statistically significant reductions in liver fat content, markers of liver injury ...
NCT07221227 | A Pivotal Clinical Study to Investigate ...
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of ...
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.
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