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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.