A Study of BOS-580 in Obese Subjects At Risk For, or with Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) with an Extension
Purpose
This is a randomized, blinded, placebo-controlled study of BOS-580 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.
Condition
- Nonalcoholic Steatohepatitis (NASH)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
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Experimental Cohort A1: BOS-580 Dose 1 or placebo (PBO) |
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Experimental Cohort A2: BOS-580 Dose 2 or PBO |
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Experimental Cohort A3: BOS-580 Dose 3 or PBO |
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Experimental Cohort A4: BOS-580 Dose 4 or PBO |
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Experimental Cohort A5: BOS-580 Dose 5 or PBO |
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Experimental Part B: BOS-580 Dose 1 or PBO |
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Experimental Part C: BOS-580 Dose 1 |
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Experimental Part D: BOS-580 Dose 6 or PBO |
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Experimental Part D: BOS-580 Dose 1 or PBO |
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Recruiting Locations
Georgetown, Texas 78626
More Details
- Status
- Recruiting
- Sponsor
- Boston Pharmaceuticals