Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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
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.
You may not be if
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).
Participants that received their 24 week dose in Part B \> 10 weeks prior to enrollment into Part C
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.
Clareo Health | A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension
