NCT03697109 · OUTCOME

Change in Percent Tissue Fat Mass During the OL 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: MEAN
Unit: Percentage
Interval / dispersion: Standard Deviation
Time frame: Baseline and Week 22 (end of OL Phase)

What was measured

Tissue fat mass was measured by DXA scan.

Analysis population: The analysis population was patients in the modified ITT-OL (mITT-OL) Population including all enrolled patients who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.

Groups in this outcome

Relacorilant (OL Phase)

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.

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 (OL Phase)	151

Reported measurements

Baseline Percent Tissue Fat Mass

Analysis denominator · Participants

Group	Source count
Relacorilant (OL Phase)	131

Values in Percentage · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Relacorilant (OL Phase)	46.4	8.39	Not reported	Not reported	Not reported

Change from Baseline in Percent Tissue Fat Mass at Week 22

Analysis denominator · Participants

Group	Source count
Relacorilant (OL Phase)	71

Values in Percentage · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Relacorilant (OL Phase)	-1.8	2.73	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
8.39
value
46.4
denoms
counts
group Id
OG000
value
131
units
Participants
title
Baseline Percent Tissue Fat Mass
categories
measurements
group Id
OG000
spread
2.73
value
-1.8
denoms
counts
group Id
OG000
value
71
units
Participants
title
Change from Baseline in Percent Tissue Fat Mass at Week 22

denoms

counts
group Id
OG000
value
151
units
Participants

description

Tissue fat mass was measured by DXA scan.

dispersion Type

Standard Deviation

groups

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
OG000
title
Relacorilant (OL Phase)

param Type

MEAN

population Description

The analysis population was patients in the modified ITT-OL (mITT-OL) Population including all enrolled patients who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.

reporting Status

POSTED

time Frame

Baseline and Week 22 (end of OL Phase)

title

Change in Percent Tissue Fat Mass During the OL Phase

type

OTHER_PRE_SPECIFIED

unit Of Measure

Percentage

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice