A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension
NCT04880031 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 231
Last updated 2025-10-30
Summary
This is a randomized, blinded, placebo-controlled study of Efimosfermin 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.
Conditions
- Nonalcoholic Steatohepatitis (NASH)
Interventions
- DRUG
-
Efimosfermin
Efimosfermin will be administered by subcutaneous injection
- DRUG
-
Placebo will be administered by subcutaneous injection
Sponsors & Collaborators
-
GSK Research and Development Limited
collaborator UNKNOWN -
Boston Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-30
- Primary Completion
- 2025-10-27
- Completion
- 2025-10-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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