Trial · NCT03697109
A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
NCT03697109, Phase 3, Completed, Corcept Therapeutics; results first posted 2025-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome. Trials, record NCT03697109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03697109
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
- NCT number
- NCT03697109
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 152 participants, actual
- Lead sponsor
- Corcept Therapeutics
- Conditions
- Cushing Syndrome
- Interventions
- Relacorilant, Placebo
- First posted
- 2018-10-05
- Last updated
- 2025-07-16
- Results first posted
- 2025-04-24
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason. |
| Primary | Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase | |
| Secondary | Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase | Before and at time intervals up to 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | |
| Secondary | Change in Hemoglobin HbA1c During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | |
| Secondary | Change in 2-hour Plasma Glucose During the RW Phase | Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | Plasma glucose was measured using the 2-hour Oral Glucose Tolerance Test (oGTT). |
| Secondary | Change in SBP and DBP During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | Blood pressure was measured by 24-hour ABPM. |
| Secondary | Change in Body Weight During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | |
| Secondary | Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase | Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase) | |
| Other | Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The Cushing QoL patient questionnaire, which evaluates the health-related QoL in patients with Cushing syndrome, comprises 12 questions, each with 5 possible answers. The total score ranges from 12-60, with a higher score indicating improvement in QoL. The Cushing QoL instrument addresses known problem areas associated with Cushing syndrome including trouble sleeping, wound healing/bruising, irritability/mood swings/anger, self-confidence, physical changes, ability to participate in activities, interactions with friends and family, memory issues, and future health concerns. |
| Other | Percent Change in Tissue Fat Mass During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The analysis population was patients in the Intent-to-Treat (ITT-RW) Population who met the HTN response criteria at conclusion of the OL Phase. The ITT-RW Population included all patients who were randomized in the RW Phase and received at least 1 dose of study drug post randomization. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | OL Phase: Up to 22 weeks; RW Phase: up to 18 weeks after completion of the OL Phase | The analysis population was patients in the Safety Population, which included all enrolled patients who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) During the RW Phase | Before and at time intervals up to 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The analysis population was patients in the ITT-RW Population who had DM/IGT with or without HTN at Baseline. | hours x mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Hemoglobin HbA1c During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The analysis population was patients in the ITT-RW Population who had DM/IGT with or without HTN at Baseline. | Percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 2-hour Plasma Glucose During the RW Phase | Before and 2 hours post glucose drink at Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The analysis population was patients in the ITT-RW Population who had DM/IGT with or without HTN at Baseline. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in SBP and DBP During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The analysis population was patients in the ITT-RW Population who had HTN with or without DM/IGT at Baseline. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Body Weight During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The analysis population was patients in the ITT-RW Population. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase | Week 22 (end of OL Phase) and up to Week 36 (Week 12 of RW Phase) | The analysis population was patients in the ITT-RW Population who had DM/IGT at Baseline and received antidiabetic medication during the RW Phase. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Cushing Quality of Life (QoL) Normalized Total Score During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The analysis population was patients in the ITT-RW Population. | score on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Percent Change in Tissue Fat Mass During the RW Phase | Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase) | The analysis population was patients in the ITT-RW Population. | Percent Change | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Relacorilant (RW Phase) | SBP | 3 | Participants | |
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Placebo (RW Phase) | SBP | 1 | Participants | |
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Relacorilant (RW Phase) | DBP | 1 | Participants | |
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Placebo (RW Phase) | DBP | 1 | Participants | |
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Relacorilant (RW Phase) | SBP and/or DBP | 3 | Participants | |
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Placebo (RW Phase) | SBP and/or DBP | 4 | Participants | |
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Relacorilant (RW Phase) | Use of rescue medication | 0 | Participants | |
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Placebo (RW Phase) | Use of rescue medication | 7 | Participants | |
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Relacorilant (RW Phase) | Treatment discontinuation | 2 | Participants | |
| Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase. | Placebo (RW Phase) | Treatment discontinuation | 3 | Participants |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label (OL) Phase | STARTED | Relacorilant (OL Phase) | 152 | |
| Open-label (OL) Phase | STARTED | Relacorilant (RW Phase) | 0 | |
| Open-label (OL) Phase | STARTED | Placebo (RW Phase) | 0 | |
| Open-label (OL) Phase | COMPLETED | Relacorilant (OL Phase) | 95 | |
| Open-label (OL) Phase | COMPLETED | Relacorilant (RW Phase) | 0 | |
| Open-label (OL) Phase | COMPLETED | Placebo (RW Phase) | 0 | |
| Open-label (OL) Phase | NOT COMPLETED | Relacorilant (OL Phase) | 57 | |
| Open-label (OL) Phase | NOT COMPLETED | Relacorilant (RW Phase) | 0 | |
| Open-label (OL) Phase | NOT COMPLETED | Placebo (RW Phase) | 0 | |
| Randomized-withdrawal (RW) Phase | STARTED | Relacorilant (OL Phase) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events279
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Relacorilant (OL Phase) | 43 | 152 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Relacorilant (RW Phase) | 2 | 30 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Placebo (RW Phase) | 2 | 32 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Relacorilant (OL Phase) | 41 | 152 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Relacorilant (RW Phase) | 5 | 30 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo (RW Phase) | 6 | 32 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Relacorilant (OL Phase) | 30 | 152 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Relacorilant (RW Phase) | 3 | 30 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo (RW Phase) | 3 | 32 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Relacorilant (OL Phase) | 21 | 152 |
1 to 10 of 279Source ClinicalTrials.gov
See all 279 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relacorilant (OL Phase) | 2 | 152 |
| Total, all-cause mortality | Relacorilant (RW Phase) | 0 | 30 |
| Total, all-cause mortality | Placebo (RW Phase) | 0 | 32 |
| Total, other adverse events | Relacorilant (OL Phase) | 147 | 152 |
| Total, other adverse events | Relacorilant (RW Phase) | 22 | 30 |
| Total, other adverse events | Placebo (RW Phase) | 27 | 32 |
| Total, serious adverse events | Relacorilant (OL Phase) | 29 | 152 |
| Total, serious adverse events | Relacorilant (RW Phase) | 5 | 30 |
| Total, serious adverse events | Placebo (RW Phase) | 1 | 32 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Relacorilant (RW Phase) vs Placebo (RW Phase): Number of Patients With Any Increase or Modification in Diabetes Medication During the RW Phase |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03697109
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