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Compensation: Varies

Number of Visits: 128

231 Participants Needed

BOS-580 for Nonalcoholic Steatohepatitis (NASH)

Recruiting at 51 trial locations

Overseen ByStudy 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 GroupAll trial participants will receive the active study treatment (no placebo)

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 is a randomized, blinded, placebo-controlled study of Efimosfermin in obese participants at risk for, or with biopsy-confirmed, nonalcoholic steatohepatitis (NASH), with a single arm open-label extension. It includes Parts A, B, C and D.

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.

How does the drug BOS-580 for NASH differ from other treatments?

The research does not provide specific information about BOS-580, so its unique features compared to other NASH treatments are not clear from the available data.¹ ² ³ ⁴ ⁵

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.

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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?

9Treatment groups

Experimental Treatment

Group I: Part D: Efimosfermin Dose 6 or PBOExperimental Treatment2 Interventions

Group II: Part D: Efimosfermin Dose 1 or PBOExperimental Treatment2 Interventions

Group III: Part C: Efimosfermin Dose 1Experimental Treatment1 Intervention

Group IV: Part B: Efimosfermin Dose 1 or PBOExperimental Treatment2 Interventions

Group V: Cohort A5: Efimosfermin Dose 5 or PBOExperimental Treatment2 Interventions

Group VI: Cohort A4: Efimosfermin Dose 4 or PBOExperimental Treatment2 Interventions

Group VII: Cohort A3: Efimosfermin Dose 3 or PBOExperimental Treatment2 Interventions

Group VIII: Cohort A2: Efimosfermin Dose 2 or PBOExperimental Treatment2 Interventions

Group IX: Cohort A1: Efimosfermin Dose 1 or placebo (PBO)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Pharmaceuticals

Lead Sponsor

Trials

Recruited

910+

Published Research Related to This Trial

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]

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]