The trial is taking place at:

Houston Research Institute | Houston, TX

Veeva-enabled site

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

Boston Scientific logo

Boston Scientific

Status and phase

Active, not recruiting
Phase 2

Conditions

Nonalcoholic Steatohepatitis (NASH)

Treatments

Drug: BOS-580
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04880031
BOS-580-201

Details and patient eligibility

About

This is a safety study to evaluate BOS-580 administered subcutaneously over 12 weeks in Part A or 24 weeks in Part B.

Enrollment

82 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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%
  • Subjects with a condition that requires substantial anticoagulant medication may not be eligible for the study enrollment (e.g., deep vein thrombosis).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

82 participants in 6 patient groups

Cohort A1: BOS-580 Dose 1 or placebo (PBO)
Experimental group
Treatment:
Drug: Placebo
Drug: BOS-580
Cohort A2: BOS-580 Dose 2 or PBO
Experimental group
Treatment:
Drug: Placebo
Drug: BOS-580
Cohort A3: BOS-580 Dose 3 or PBO
Experimental group
Treatment:
Drug: Placebo
Drug: BOS-580
Cohort A4: BOS-580 Dose 4 or PBO
Experimental group
Treatment:
Drug: Placebo
Drug: BOS-580
Cohort A5: BOS-580 Dose 5 or PBO
Experimental group
Treatment:
Drug: Placebo
Drug: BOS-580
Cohort B: BOS-580 Dose 1 or PBO
Experimental group
Treatment:
Drug: Placebo
Drug: BOS-580

Trial contacts and locations

39

Loading...

Central trial contact

Study Medical Director

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems