NCT03697109 · OUTCOME

Change in Body Weight During the RW Phase

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.

Measure: LEAST_SQUARES_MEAN
Unit: kg
Interval / dispersion: 95% Confidence Interval
Time frame: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

Analysis population: The analysis population was patients in the ITT-RW Population.

Groups in this outcome

Relacorilant (RW Phase)

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.

Placebo (RW Phase)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Relacorilant (RW Phase)	26
Placebo (RW Phase)	30

Reported measurements

Source class 1

Values in kg · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Relacorilant (RW Phase)	-1.21	Not reported	-2.685	0.269	Not reported
Placebo (RW Phase)	0.54	Not reported	-0.851	1.939	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
-2.685
upper Limit
0.269
value
-1.21
group Id
OG001
lower Limit
-0.851
upper Limit
1.939
value
0.54

denoms

counts
group Id
OG000
value
26
group Id
OG001
value
30
units
Participants

dispersion Type

95% Confidence Interval

groups

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
OG000
title
Relacorilant (RW Phase)
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
OG001
title
Placebo (RW Phase)

param Type

LEAST_SQUARES_MEAN

population Description

The analysis population was patients in the ITT-RW Population.

reporting Status

POSTED

time Frame

Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

title

Change in Body Weight During the RW Phase

type

SECONDARY

unit Of Measure

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Preserved source evidence · Not medical advice