BOS-580 for Nonalcoholic Steatohepatitis (NASH)

No longer recruiting at 51 trial locations

Overseen By Study Medical Director

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boston Pharmaceuticals

Must not be taking: Anticoagulants, Investigational drugs

Disqualifiers: Cirrhosis, Triglycerides ≥ 500 mg/dL, Type 1 diabetes, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 128

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BOS-580 to determine its effectiveness for individuals with nonalcoholic steatohepatitis (NASH), a liver condition common in those who are obese. Researchers aim to find out if this treatment can reduce liver fat and improve liver health in people at risk for or diagnosed with NASH. Participants will be divided into groups to receive either different doses of BOS-580 or a placebo (a substance with no active medication). Ideal candidates have been diagnosed with NASH through a liver biopsy and have a history of related conditions like obesity or type 2 diabetes. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on substantial anticoagulant medication, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Efimosfermin, also known as BOS-580, has been generally well-tolerated in past studies. In one study, 89% of participants experienced significant improvements in liver health, suggesting the treatment might work well with manageable side effects.

Other trials have demonstrated that Efimosfermin significantly reduced liver fat and signs of liver damage, which are positive outcomes. Most participants did not report serious side effects, indicating the treatment was safe for them.

Although this trial is in an early stage, the treatment has already passed initial safety tests. While more research is needed, early results are promising for Efimosfermin's safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for NASH?

Most treatments for Nonalcoholic Steatohepatitis (NASH), like lifestyle changes and medications such as vitamin E and pioglitazone, focus on managing symptoms and liver inflammation. However, BOS-580 stands out because it introduces a new approach with its active ingredient, Efimosfermin. This compound works by targeting the underlying causes of NASH at a cellular level, potentially offering more direct intervention than current options. Researchers are excited because Efimosfermin could improve liver health more effectively and with fewer side effects, providing hope for a condition that currently lacks comprehensive treatment options.

What evidence suggests that this trial's treatments could be effective for NASH?

Research has shown that Efimosfermin, also known as BOS-580, offers promising results for treating nonalcoholic steatohepatitis (NASH). In previous studies, Efimosfermin significantly reduced liver fat and improved signs of liver damage and scarring. Participants experienced better liver health without major safety concerns. This trial will test various doses of Efimosfermin, with some participants receiving a placebo. These findings suggest Efimosfermin could effectively treat NASH by reducing liver damage and fat. Overall, the evidence is encouraging for those exploring new treatment options for this condition. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for obese adults aged 18-75 with a BMI of 30-45 who are at risk for or have NASH, as indicated by specific liver stiffness and injury markers. Candidates must not have cirrhosis, extremely high triglycerides, type 1 diabetes, significant recent weight changes, or an HbA1c >9.5%.

Inclusion Criteria

Hepatic fat fraction (HFF) measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥10%

My liver stiffness is within the required range and my AST levels are above 20U/L.

My BMI is between 30 and 45.

Exclusion Criteria

I have type 1 diabetes or have had diabetic ketoacidosis or tested positive for GAD auto-antibodies.

I have been diagnosed with cirrhosis.

I have lost or gained more than 5% of my body weight or 5 kg in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive Efimosfermin or placebo with monitoring of safety and tolerability

12 weeks

Visits at Baseline, Week 12

Treatment Part B

Continuation of treatment with Efimosfermin or placebo, monitoring of blood pressure and heart rate

24 weeks

Visits at Week 24

Treatment Part C

Further continuation of treatment with Efimosfermin or placebo, monitoring of safety and tolerability

56 weeks

Visits at Week 56

Treatment Part D

Final phase of treatment with Efimosfermin or placebo, monitoring of safety and tolerability

48 weeks

Visits at Weeks 36 and 48

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment long-term with Efimosfermin

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• BOS-580
• Placebo

Trial Overview The study tests BOS-580's safety in treating NASH over two periods: one group receives the drug subcutaneously for either 12 weeks (Part A) or 24 weeks (Part B), while another group gets a placebo to compare effects.

How Is the Trial Designed?

Group I: Part D: Efimosfermin Dose 6 or PBO Experimental Treatment 2 Interventions

Group II: Part D: Efimosfermin Dose 1 or PBO Experimental Treatment 2 Interventions

Group III: Part C: Efimosfermin Dose 1 Experimental Treatment 1 Intervention

Group IV: Part B: Efimosfermin Dose 1 or PBO Experimental Treatment 2 Interventions

Group V: Cohort A5: Efimosfermin Dose 5 or PBO Experimental Treatment 2 Interventions

Group VI: Cohort A4: Efimosfermin Dose 4 or PBO Experimental Treatment 2 Interventions

Group VII: Cohort A3: Efimosfermin Dose 3 or PBO Experimental Treatment 2 Interventions

Group VIII: Cohort A2: Efimosfermin Dose 2 or PBO Experimental Treatment 2 Interventions

Group IX: Cohort A1: Efimosfermin Dose 1 or placebo (PBO) Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Boston Pharmaceuticals

Lead Sponsor

Trials

12

Recruited

910+

GSK Research and Development Limited

Collaborator

Published Research Related to This Trial

In a 72-week trial, obeticholic acid (OCA) was found to improve liver health in patients with non-alcoholic steatohepatitis (NASH), with 44% of patients experiencing weight loss, which contributed to better liver histology and serum ALT levels.

While OCA treatment combined with weight loss showed additive benefits for liver health, it also led to adverse effects on certain metabolic markers like alkaline phosphatase and cholesterol levels, highlighting the need to consider these effects when evaluating new NASH therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and metabolic effects associated with weight changes and obeticholic acid in non-alcoholic steatohepatitis. Hameed, B., Terrault, NA., Gill, RM., et al.[2020]

Out of 49 therapeutic options investigated for nonalcoholic steatohepatitis (NASH), only six showed potential for conditional FDA approval based on histological surrogate endpoints, with obeticholic acid being the only therapy to demonstrate significant fibrosis improvement in a phase 3 trial.

Several other treatments, including cenicriviroc, liraglutide, semaglutide, and resmetirom, showed promising results in earlier phase studies, but more research is needed to confirm their efficacy and safety in preventing NASH progression to cirrhosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Horizon scanning of therapeutic modalities for nonalcoholic steatohepatitis. Patikorn, C., Veettil, SK., Phisalprapa, P., et al.[2022]

Citations

1. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253%2825%2900067-6/abstract

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.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468125325000676

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. These results ...

3. bostonpharmaceuticals.com bostonpharmaceuticals.com/s/2024-11-AASLD_5017_Podium_Efimosfermin-Phase-2-Part-B-Study-Results-Preliminary-Final-Amd.pdf

Once-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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04880031

NCT04880031 | A Study of BOS-580 in Obese Subjects at ... This is a randomized, blinded, placebo-controlled study of Efimosfermin in obese participants at risk for, or with biopsy-confirmed, nonalcoholic ...

5. natap.org natap.org/2024/AASLD/AASLD_31.htm

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 and fibrosis, ...

6. withpower.com withpower.com/trial/phase-3-non-alcoholic-fatty-liver-disease-7-2021-4a720

BOS-580 for Nonalcoholic Steatohepatitis (NASH) Prior Safety DataThis treatment has passed at least one previous human trial. What You Need to Know Before You Apply. What is the purpose of this trial? This ...