Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
Summary
This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.
Timeline
- Start
- 2021-06-04
- Primary completion
- 2023-02-14
- Completion
- 2024-10-08
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry p <0.0001; Treatment Difference 34.65 (95% CI 10.04 to 59.26); Cochran-Mantel-Haenszel reads as mixed primary results NCT04929483 ↗
registry p = 0.1039; Treatment Difference 14.45 (95% CI -8.71 to 37.62); Cochran-Mantel-Haenszel reads as mixed primary results NCT04929483 ↗
registry p = 0.0085; Treatment Difference 18.87 (95% CI 5.24 to 32.50); Cochran-Mantel-Haenszel reads as mixed primary results NCT04929483 ↗
release “ENLIVEN results demonstrated that treatment with pegozafermin 30mg weekly and 44mg every-two-week doses resulted in statistically significant changes on both primary histology endpoints” reads as met primary endpoint 89bio.com ↗
release “ENLIVEN achieved high statistical significance on primary histology endpoints” reads as met primary endpoint 89bio.com ↗
release “The results show that pegozafermin not only improved patients’ FAST scores but also achieved both MASH resolution and fibrosis improvement” reads as met primary endpoint 89bio.com ↗
Publications
- Tseng CL, Balic K, Charlton RW, Margalit M, Mansbach H, Savic RM. Population Pharmacokinetics and Pharmacodynamics of Pegozafermin in Patients with Nonalcoholic Steatohepatitis. Clin Pharmacol Ther. 2023 Dec;114(6):1323-1331. doi: 10.1002/cpt.3046. Epub 2023 Oct 2.
- Loomba R, Sanyal AJ, Kowdley KV, Bhatt DL, Alkhouri N, Frias JP, Bedossa P, Harrison SA, Lazas D, Barish R, Gottwald MD, Feng S, Agollah GD, Hartsfield CL, Mansbach H, Margalit M, Abdelmalek MF. Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH. N Engl J Med. 2023 Sep 14;389(11):998-1008. doi: 10.1056/NEJMoa2304286. Epub 2023 Jun 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegozafermin | Protein / enzyme biologic | 15 mg | Subcutaneous |
| Subject | Pegozafermin | Protein / enzyme biologic | 30 mg | Subcutaneous |
| Subject | Pegozafermin | Protein / enzyme biologic | 44 mg | Subcutaneous |