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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-13

Study Completion Date

2019-08-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Cushing Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ATR-101

During the 4-week randomized withdrawal period, eligible subjects will receive ATR-101 at the same dose level being used at the completion of the open-label dose-escalation period.

Group Type EXPERIMENTAL

ATR-101

Intervention Type DRUG

During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks at the same dose level being used at the completion of the open-label dose-escalation period.

Placebo

During the 4-week randomized withdrawal period, eligible subjects will receive a placebo that matches the same ATR-101 dose level being used at the completion of the open-label dose-escalation period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks with placebo that matches the same ATR-101 dose level being used at the completion of the open-label dose-escalation period.

Interventions

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ATR-101

During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks at the same dose level being used at the completion of the open-label dose-escalation period.

Intervention Type DRUG

Placebo

During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks with placebo that matches the same ATR-101 dose level being used at the completion of the open-label dose-escalation period.

Intervention Type DRUG

Other Intervention Names

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nevanimibe HCl

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of endogenous Cushing's syndrome
* Baseline UFC 1.3 to 10 × upper limit of normal (ULN)
* If previous pituitary surgery, participants must be at least 3 months since surgery at the time of screening
* BMI between 18 and 60 kg/m2, inclusive

Exclusion Criteria

* Pseudo-Cushing's syndrome, cyclic Cushing's syndrome or current iatrogenic Cushing's syndrome
* Candidates for surgical treatment of Cushing's syndrome, unless surgery is not anticipated to occur during the study
* Normal late night salivary cortisol or 24-hr urine free cortisol
* Radiotherapy of the pituitary within 6 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No