A Study of NGM282 in Patients With Primary Sclerosing Cholangitis

Summary

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

Timeline

Start

2016-03

Primary completion

2017-06

Completion

2017-06

Outcome

Missed primary endpoint

registry analysis (superiority test); NGM282 1.0 mg vs Placebo; p = 0.434; Hodges-Lehmann estimate -14.0 (95% CI -68.0 to 28.0); Wilcoxon (Mann-Whitney) NCT02704364 ↗

registry analysis (superiority test); NGM282 3.0 mg vs Placebo; p = 0.646; Hodges-Lehmann estimate 13.0 (95% CI -41.0 to 71.0); Wilcoxon (Mann-Whitney) NCT02704364 ↗

release “This study did not meet the primary endpoint of statistically significant change in alkaline phosphatase (ALP), a presumptive biomarker of PSC disease progression.” ngmbio.com ↗

release “Phase 2 study of aldafermin for the treatment of PSC. While that Phase 2 study did not meet its primary endpoint” ngmbio.com ↗

Publications

• Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aldafermin	Protein / enzyme biologic	1 mg	—
Subject	Aldafermin	Protein / enzyme biologic	3 mg	—

Indications