Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)

Summary

The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).

Timeline

Start

2015-11-04

Primary completion

2016-07-01

Completion

2016-07-01

Outcome

Met primary endpoint

Stopped: “Study stopped early after review of safety and efficacy demonstrated efficacy proof-of-concept and need for dose reduction.”

registry analysis (superiority test); Seladelpar 200 mg vs Placebo; p <0.0001; Difference in LSM -60.99 (95% CI -72.85 to -49.13) NCT02609048 ↗

registry analysis (superiority test); Seladelpar 50 mg vs Placebo; p <0.0001; Difference in Least Squares Mean (LSM) -51.37 (95% CI -63.30 to -39.44) NCT02609048 ↗

Publications

• Jones D, Boudes PF, Swain MG, Bowlus CL, Galambos MR, Bacon BR, Doerffel Y, Gitlin N, Gordon SC, Odin JA, Sheridan D, Worns MA, Clark V, Corless L, Hartmann H, Jonas ME, Kremer AE, Mells GF, Buggisch P, Freilich BL, Levy C, Vierling JM, Bernstein DE, Hartleb M, Janczewska E, Rochling F, Shah H, Shiffman ML, Smith JH, Choi YJ, Steinberg A, Varga M, Chera H, Martin R, McWherter CA, Hirschfield GM. Seladelpar (MBX-8025), a selective PPAR-delta agonist, in patients with primary biliary cholangitis with an inadequate response to ursodeoxycholic acid: a double-blind, randomised, placebo-controlled, phase 2, proof-of-concept study. Lancet Gastroenterol Hepatol. 2017 Oct;2(10):716-726. doi: 10.1016/S2468-1253(17)30246-7. Epub 2017 Aug 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Seladelpar	Small molecule	50 mg	Oral
Subject	Seladelpar	Small molecule	200 mg	Oral

Indications