NCT03697109 · OUTCOME

Percent Change in Tissue Fat Mass 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: Percent Change
Interval / dispersion: 95% Confidence Interval
Time frame: Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

What was measured

Tissue fat mass was measured by dual energy X-ray absorptiometry (DXA) scan. Reported are change in in absolute tissue fat mass and change in percent tissue fat mass.

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)	17
Placebo (RW Phase)	22

Reported measurements

Absolute Tissue Fat Mass

Values in Percent Change · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Relacorilant (RW Phase)	-0.64	Not reported	-1.684	0.400	Not reported
Placebo (RW Phase)	1.67	Not reported	0.776	2.573	Not reported

Percent Tissue Fat Mass

Values in Percent Change · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Relacorilant (RW Phase)	-0.14	Not reported	-1.031	0.759	Not reported
Placebo (RW Phase)	1.66	Not reported	0.887	2.437	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
-1.684
upper Limit
0.400
value
-0.64
group Id
OG001
lower Limit
0.776
upper Limit
2.573
value
1.67
title
Absolute Tissue Fat Mass
categories
measurements
group Id
OG000
lower Limit
-1.031
upper Limit
0.759
value
-0.14
group Id
OG001
lower Limit
0.887
upper Limit
2.437
value
1.66
title
Percent Tissue Fat Mass

denoms

counts
group Id
OG000
value
17
group Id
OG001
value
22
units
Participants

description

Tissue fat mass was measured by dual energy X-ray absorptiometry (DXA) scan. Reported are change in in absolute tissue fat mass and change in percent tissue fat mass.

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

Percent Change in Tissue Fat Mass During the RW Phase

type

OTHER_PRE_SPECIFIED

unit Of Measure

Percent Change

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Preserved source evidence · Not medical advice