All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
The purpose of this study is to determine whether dosing tropifexor is safe and tolerable.
Aug 12, 2020
May 29, 2020
Mar 31, 2021
18 Years and older (Adult, Older Adult)
-Presence of Liver Disease
Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
Subjects taking the following medicines UNLESS on a stable dose (within 25% of baseline dose) for at least 3 months before randomization:
Type 1 diabetes and Uncontrolled Type 2 diabetes defined as HbAlc ≥ 9.5% at screening
-Calculated eGFR ≤ 60 mL/min/1.73m2 (using the MDRD formula) Subjects with contraindications to MRI imaging.