drugset / Trial / NCT03551522
A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH) OLE phase was not analyzed due to the early termination of the study
Timeline
- Start
- 2018-04-30
- Primary completion
- 2019-05-08
- Completion
- 2020-08-10
Outcome
Missed primary endpoint
Stopped: “unexpected histological findings”
registry Seladelpar 10 mg vs Placebo; p = 0.0874; LS Mean of Difference 11.02 (95% CI -1.63 to 23.67); ANCOVA NCT03551522 ↗
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.
- Beyer C, Hutton C, Andersson A, Imajo K, Nakajima A, Kiker D, Banerjee R, Dennis A. Comparison between magnetic resonance and ultrasound-derived indicators of hepatic steatosis in a pooled NAFLD cohort. PLoS One. 2021 Apr 1;16(4):e0249491. doi: 10.1371/journal.pone.0249491. eCollection 2021.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Seladelpar | Small molecule | 10 mg | — |
| Subject | Seladelpar | Small molecule | 20 mg | — |
| Subject | Seladelpar | Small molecule | 50 mg | — |