Participant flow

A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome · Source last updated 2025-07-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients will receive relacorilant increased sequentially from 100 mg once daily to a maximum dose of 400 mg once daily. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.

   id

   FG000

   title

   Relacorilant (OL Phase)

2. description

   Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase. Relacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.

   id

   FG001

   title

   Relacorilant (RW Phase)

3. description

   Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug. Placebo: Placebo matched to study drug

   id

   FG002

   title

   Placebo (RW Phase)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         152

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         95

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Open-label (OL) Phase

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Lack of Efficacy

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         30

      3. group Id

         FG002

         num Subjects

         32

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         27

      3. group Id

         FG002

         num Subjects

         31

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Randomized-withdrawal (RW) Phase

pre Assignment Details

A total of 404 patients were screened and 152 were enrolled.

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Preserved source evidence · Not medical advice