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

ArmDescriptionAssigned Intervention
Experimental
Cohort A1: BOS-580 Dose 1 or placebo (PBO)
  • Drug: BOS-580
    BOS-580 will be administered by subcutaneous injection
  • Drug: Placebo
    Placebo will be administered by subcutaneous injection
Experimental
Cohort A2: BOS-580 Dose 2 or PBO
  • Drug: BOS-580
    BOS-580 will be administered by subcutaneous injection
  • Drug: Placebo
    Placebo will be administered by subcutaneous injection
Experimental
Cohort A3: BOS-580 Dose 3 or PBO
  • Drug: BOS-580
    BOS-580 will be administered by subcutaneous injection
  • Drug: Placebo
    Placebo will be administered by subcutaneous injection
Experimental
Cohort A4: BOS-580 Dose 4 or PBO
  • Drug: BOS-580
    BOS-580 will be administered by subcutaneous injection
  • Drug: Placebo
    Placebo will be administered by subcutaneous injection
Experimental
Cohort A5: BOS-580 Dose 5 or PBO
  • Drug: BOS-580
    BOS-580 will be administered by subcutaneous injection
  • Drug: Placebo
    Placebo will be administered by subcutaneous injection
Experimental
Part B: BOS-580 Dose 1 or PBO
  • Drug: BOS-580
    BOS-580 will be administered by subcutaneous injection
  • Drug: Placebo
    Placebo will be administered by subcutaneous injection
Experimental
Part C: BOS-580 Dose 1
  • Drug: BOS-580
    BOS-580 will be administered by subcutaneous injection
Experimental
Part D: BOS-580 Dose 6 or PBO
  • Drug: BOS-580
    BOS-580 will be administered by subcutaneous injection
  • Drug: Placebo
    Placebo will be administered by subcutaneous injection
Experimental
Part D: BOS-580 Dose 1 or PBO
  • Drug: BOS-580
    BOS-580 will be administered by subcutaneous injection
  • Drug: Placebo
    Placebo will be administered by subcutaneous injection

Recruiting Locations

Pinnacle Clinical Research - Georgetown
Georgetown, Texas 78626

More Details

Status
Recruiting
Sponsor
Boston Pharmaceuticals

Study Contact

Study Medical Director
(617) 655-9681
clinicaltrials@bostonpharmaceuticals.com