NCT03697109 · OUTCOME

Change in Hemoglobin HbA1c 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: Percentage
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 who had DM/IGT with or without HTN at Baseline.

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)	16
Placebo (RW Phase)	19

Reported measurements

Source class 1

Values in Percentage · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Relacorilant (RW Phase)	0.06	Not reported	-0.270	0.383	Not reported
Placebo (RW Phase)	0.28	Not reported	-0.022	0.578	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
-0.270
upper Limit
0.383
value
0.06
group Id
OG001
lower Limit
-0.022
upper Limit
0.578
value
0.28

denoms

counts
group Id
OG000
value
16
group Id
OG001
value
19
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 who had DM/IGT with or without HTN at Baseline.

reporting Status

POSTED

time Frame

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

title

Change in Hemoglobin HbA1c During the RW Phase

type

SECONDARY

unit Of Measure

Percentage

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

Preserved source evidence · Not medical advice