A Study of BOS-580 in Obese Subjects at Risk for Nonalcoholic Steatohepatitis (NASH)

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a safety study to evaluate BOS-580 administered subcutaneously over 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Pharmaceuticals

Criteria

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) within the range of 30 to 45 kg/m^2 (inclusive)

• Hepatic fat fraction (HFF) measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) > 10%

• Liver injury and fibrosis assessment based on vibration controlled transient elastography (VCTE) liver stiffness measurement (LSM) score and aspartate aminotransferase (AST).

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)

• History of type 1 diabetes, diabetic ketoacidosis, or positive glutamic acid decarboxylase (GAD) auto-antibodies (latent autoimmune diabetes in adults)

• Hemoglobin A1c > 9.5%.