Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
Summary
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
Timeline
- Start
- 2015-07-31
- Primary completion
- 2019-12-06
- Completion
- 2020-01-17
Outcome
Met primary endpoint
registry analysis (superiority test); Part 1: Aldafermin 3.0 mg vs Part 1: Placebo; p <0.001; Difference in least squares means -8.84 (96% CI -12.09 to -5.59) NCT02443116 ↗
registry Part 2: Aldafermin 0.3 mg vs Part 2: Aldafermin 1.0 mg; p <0.0001; Difference in least squares means -5.73 NCT02443116 ↗
registry Part 3: Aldafermin 1.0 mg vs Part 3: Placebo; p = 0.0018; Difference in least squares means -4.97 NCT02443116 ↗
release “NGM282 met the primary endpoint and key secondary endpoints in a Phase 2 trial of patients with nonalcoholic steatohepatitis (NASH).” ngmbio.com ↗
Publications
- Alkhouri N, Beyer C, Shumbayawonda E, Andersson A, Yale K, Rolph T, Chung RT, Vuppalanchi R, Cusi K, Loomba R, Pansini M, Dennis A. Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. J Hepatol. 2025 Mar;82(3):438-445. doi: 10.1016/j.jhep.2024.08.031. Epub 2024 Sep 25.
- Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1.
- 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.
- Loomba R, Ling L, Dinh DM, DePaoli AM, Lieu HD, Harrison SA, Sanyal AJ. The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in NASH. Hepatology. 2021 Jan;73(1):126-143. doi: 10.1002/hep.31523. Epub 2020 Dec 11.
- Harrison SA, Neff G, Guy CD, Bashir MR, Paredes AH, Frias JP, Younes Z, Trotter JF, Gunn NT, Moussa SE, Kohli A, Nelson K, Gottwald M, Chang WCG, Yan AZ, DePaoli AM, Ling L, Lieu HD. Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Jan;160(1):219-231.e1. doi: 10.1053/j.gastro.2020.08.004. Epub 2020 Aug 8.
- Harrison SA, Rinella ME, Abdelmalek MF, Trotter JF, Paredes AH, Arnold HL, Kugelmas M, Bashir MR, Jaros MJ, Ling L, Rossi SJ, DePaoli AM, Loomba R. NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2018 Mar 24;391(10126):1174-1185. doi: 10.1016/S0140-6736(18)30474-4. Epub 2018 Mar 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aldafermin | Protein / enzyme biologic | 0.3 mg | Subcutaneous |
| Subject | Aldafermin | Protein / enzyme biologic | 1 mg | Subcutaneous |
| Subject | Aldafermin | Protein / enzyme biologic | 3 mg | Subcutaneous |
| Subject | Aldafermin | Protein / enzyme biologic | 6 mg | Subcutaneous |