A Study of ATR-101 for the Treatment of Endogenous Cushing's Syndrome

Summary

This is a Phase 2 multicenter, randomized, double-blind, placebo controlled study of ATR-101 to evaluate the efficacy and safety of orally-administered ATR-101 in adults with endogenous Cushing's syndrome. Following wash-out (if needed), all eligible subjects will enter an open-label intra-subject dose-escalation period of 8 weeks' duration, followed either by a double-blind randomized withdrawal period of 4 weeks' duration (if the subject meets randomization criteria) or by an additional open label dosing period of 4 weeks' duration (if the subject does not meet randomization criteria).It is anticipated that the overall duration of the study per subject will range from approximately 16-22 weeks.

Timeline

Start

2017-04-13

Primary completion

2019-06-17

Completion

2019-08-12

Outcome

Outcome not reported

Stopped (Enrollment): “Slow enrollment”

Drugs

Indications