Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH

Summary

The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

Timeline

Start

2016-10-24

Primary completion

2018-09-19

Completion

2018-09-19

Outcome

Met primary endpoint

registry analysis (superiority test); LMB763 100 mg vs Pooled Placebo; p = 0.0005; Geometric Mean Ratios 0.72 (90% CI 0.62 to 0.84); ANCOVA NCT02913105 ↗

registry analysis (superiority test); LMB763 50 mg vs Pooled Placebo; p = 0.0005; Geometric Mean Ratios 0.74 (90% CI 0.65 to 0.85); ANCOVA NCT02913105 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nidufexor	Small molecule	—	Oral

Indications