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NCT03697109 · OUTCOME

Change in 2-hour Plasma Glucose 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
mmol/L
Interval / dispersion
95% Confidence Interval
Time frame
Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)

What was measured

Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT).

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

GroupSource count
Relacorilant (RW Phase)15
Placebo (RW Phase)19

Reported measurements

Source class 1
Values in mmol/L · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Relacorilant (RW Phase)0.52Not reported-1.062.09Not reported
Placebo (RW Phase)2.96Not reported1.554.37Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.06
        upper Limit
        2.09
        value
        0.52
      2. group Id
        OG001
        lower Limit
        1.55
        upper Limit
        4.37
        value
        2.96
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      19
    units
    Participants
description
Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT).
dispersion Type
95% Confidence Interval
groups
  1. 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)
  2. 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
Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)
title
Change in 2-hour Plasma Glucose During the RW Phase
type
SECONDARY
unit Of Measure
mmol/L

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Preserved source evidence · Not medical advice