BOS-580 for Nonalcoholic Steatohepatitis (NASH)

Recruiting at 51 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boston Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Eligibility Criteria

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.

I am between 18 and 75 years old and can give informed consent.

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.

Treatment Details

Interventions

• BOS-580 (Unknown)
• Placebo (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.

Participant Groups

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+