drugset / Trial / NCT04880031
A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2021-09-30
- Primary completion
- 2025-10-27
- Completion
- 2025-10-27
Publications
- Noureddin M, Kowdley KV, Odrljin T, Bain G, Zhao J, Jeglinski B, Koziel MJ, Loomba R. Efimosfermin alfa (BOS-580) once per month in people with metabolic dysfunction-associated steatohepatitis with F2 or F3 fibrosis: results from a 24-week, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2026 Feb 21;407(10530):794-804. doi: 10.1016/S0140-6736(25)02276-7. Epub 2026 Feb 5.
- Loomba R, Kowdley KV, Rodriguez J, Kim NJ, Alvarez AM, Morrow L, Jeglinski B, Clawson A, Chowdhury S, Bain G, Odrljin T. Efimosfermin alfa (BOS-580), a long-acting FGF21 analogue, in participants with phenotypic metabolic dysfunction-associated steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):734-745. doi: 10.1016/S2468-1253(25)00067-6. Epub 2025 Jun 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efimosfermin | Protein / enzyme biologic | 75 mg | Subcutaneous |
| Subject | Efimosfermin | Protein / enzyme biologic | 150 mg | Subcutaneous |
| Subject | Efimosfermin | Protein / enzyme biologic | 300 mg | Subcutaneous |