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Status:

COMPLETED

A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension

Lead Sponsor:

Boston Pharmaceuticals

Collaborating Sponsors:

GSK Research and Development Limited

Conditions:

Nonalcoholic Steatohepatitis (NASH)

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

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 e...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (Part A and Part B):
  • Participant is either male or female and 18 to 75 years of age inclusive, at the time of signing the informed consent
  • Obese participants with body mass index (BMI) of ≥ 27 kg/m\^2
  • Hepatic fat fraction (HFF) measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) ≥8%
  • Liver fibrosis assessment based on a vibration controlled transient elastography (VCTE) liver stiffness measurement (LSM) score of 7.0 to 9.9 kPa (Part A only) inclusive or 7.0 to 20.0 kPa (Part B only) inclusive and Liver injury assessment measured by aspartate aminotransferase (AST) \>25U/L. A qualifying historical biopsy (confirmed eligibility based on the central pathology read) supersedes the LSM, controlled attenuation parameter (CAP) score criteria and AST criteria.
  • Histopathologically confirmed F2 or F3 stage NASH on a diagnostic liver biopsy performed during Screening or within 6 months prior to the first day of dosing for historical biopsies (Part B only).
  • History or presence of at least 2 of 4 components of metabolic syndrome: obesity/overweight, dyslipidemia (high triglycerides and/or low high density lipoprotein \[HDL\]), type 2 diabetes with elevated glycated hemoglobin (HbA1c), and hypertension.
  • Inclusion Criteria (Part C):
  • Participant must have completed the Part B of the study.
  • Participant willing to undergo liver biopsy at Week 56
  • NASH F stage \<F4 at 24 week assessment in Part B
  • Inclusion Criteria (Part D):
  • BMI of ≥ 25 kg/m\^2
  • Liver fibrosis based on assessments taken during screening visit
  • Participant should be willing and able to undergo liver biopsy during Screening (if a historical biopsy within 12 months prior to Screening is not available) and per protocol as judged by the Investigator.
  • Other inclusion criteria may apply
  • Exclusion Criteria (Part A and Part B):
  • Documented clinical, laboratory or radiologic evidence of cirrhosis (compensated or decompensated)
  • Triglycerides ≥ 500 mg/dL
  • Change in body weight (more than 5% self-reported OR 5 kg self-reported change during the previous 3 months from Screening, whichever is smaller)
  • History of type 1 diabetes, diabetic ketoacidosis, or positive glutamic acid decarboxylase (GAD) auto-antibodies (latent autoimmune diabetes in adults)
  • Hemoglobin A1c \> 9.5%
  • Participants with a condition that requires substantial anticoagulant medication may not be eligible for the study enrollment (e.g., deep vein thrombosis).
  • Exclusion Criteria (Part C):
  • • Participants that received their 24 week dose in Part B \> 10 weeks prior to enrollment into Part C
  • Exclusion Criteria (Part D):
  • Other causes of chronic liver disease
  • Documented evidence or history of decompensated liver cirrhosis.
  • History of type 1 diabetes or poorly controlled type 2 diabetes.
  • History of malignancy.
  • Use of other investigational drugs.
  • Other exclusion criteria may apply

Exclusion

    Key Trial Info

    Start Date :

    September 30 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 27 2025

    Estimated Enrollment :

    231 Patients enrolled

    Trial Details

    Trial ID

    NCT04880031

    Start Date

    September 30 2021

    End Date

    October 27 2025

    Last Update

    October 30 2025

    Active Locations (48)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 12 (48 locations)

    1

    Central Research Associates

    Birmingham, Alabama, United States, 35205

    2

    Arizona Liver Health

    Chandler, Arizona, United States, 85224

    3

    Arizona Liver Health

    Peoria, Arizona, United States, 85381

    4

    Arizona Liver Health

    Tucson, Arizona, United States, 85712