Trial · NCT04308590
A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
NCT04308590, Phase 3, Completed, Corcept Therapeutics; results first posted 2025-08-03
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 Cortisol-Secreting Adrenal Adenomas. Trials, record NCT04308590. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04308590
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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 Cortisol-Secreting Adrenal Adenomas
- NCT number
- NCT04308590
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 137 participants, actual
- Lead sponsor
- Corcept Therapeutics
- Conditions
- Hypercortisolism
- Interventions
- Relacorilant, Placebo
- First posted
- 2020-03-16
- Last updated
- 2025-09-04
- Results first posted
- 2025-08-03
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average 24-hour SBP | Baseline and Week 22 | Blood pressure was measured by 24-hour ABPM. The 24-hour average SBP is reported. |
| Primary | Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | Baseline and up to Week 26 | |
| Secondary | Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) | Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22 | AUCglucose was calculated based on results of the plasma 2-hour oGTT. |
| Secondary | Change in Average Diastolic Blood Pressure (DBP) | Baseline and Week 22 | Blood pressure was measured by 24-hour ABPM. Daytime average DBP was measured from 06:00 to 21:59. Nighttime average DBP was measure from 22:00 to 05:59. |
| Secondary | Change in Average Heart Rate (HR) | Baseline and Week 22 | Heart rate was measured by 24-hour ABPM. Daytime average HR was measured from 06:00 to 21:59. Nighttime average HR was measure from 22:00 to 05:59. |
| Secondary | Change in Average Daytime and Nighttime SBP | Baseline and Week 22 | Blood pressure was measured by 24-hour ABPM. Daytime average SBP was measured from 06:00 to 21:59. Nighttime average SBP was measure from 22:00 to 05:59. |
| Secondary | Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline | Baseline and Week 22 | |
| Secondary | Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline | Baseline and Week 22 | |
| Secondary | Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL | 2 hours post glucose drink at Week 22 | Glucose was measured using the 2 hour timepoint of the 2-hour oGTT. |
| Secondary | Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL | 2 hours post glucose drink at Week 22 | Glucose was measured using the 2 hour timepoint of the 2-hour oGTT. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Average 24-hour SBP | Baseline and Week 22 | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline. | mm Hg | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | Baseline and up to Week 26 | The analysis population was patients in the Safety Population which included all randomized 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) | Before and at time intervals up to 2 hours post glucose drink at Baseline and Week 22 | The analysis population was patients in the ITT Population who had DM/IGT with or without HTN at Baseline and had an available assessment at Week 22. | hours x mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Average Diastolic Blood Pressure (DBP) | Baseline and Week 22 | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline and had an available assessment at Week 22. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Average Heart Rate (HR) | Baseline and Week 22 | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline and had an available assessment at Week 22. | Beats per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Average Daytime and Nighttime SBP | Baseline and Week 22 | The analysis population was patients in the ITT Population who had HTN with or without DM/IGT at Baseline and had an available assessment at Week 22. | mm Hg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Hemoglobin HbA1c for Patients With HbA1c ≥5.7% at Baseline | Baseline and Week 22 | The analysis population was patients in the ITT Population who had DM/IGT with HbA1c ≥5.7% at Baseline and had an available assessment at Week 22. | Percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Change in HbA1c for Patients With HbA1c ≥6.5% at Baseline | Baseline and Week 22 | The analysis population was patients in the ITT Population who had DM/IGT with HbA1c ≥6.5% at Baseline and had an available assessment at Week 22. | Percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL | 2 hours post glucose drink at Week 22 | The analysis population was patients in the ITT Population who had DM with or without HTN at Baseline and had an available assessment at Week 22. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL | 2 hours post glucose drink at Week 22 | The analysis population was patients in the ITT Population who had IGT with or without HTN at Baseline and had an available assessment at Week 22. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average 24-hour SBP | Relacorilant | -5.56 | 95% Confidence Interval -10.459 to -0.659 | mm Hg | |
| Change in Average 24-hour SBP | Placebo | -2.89 | 95% Confidence Interval -6.794 to 1.006 | mm Hg | |
| Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | Relacorilant | 67 | Participants | ||
| Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | Placebo | 60 | Participants | ||
| Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) | Relacorilant | -1.566 | 95% Confidence Interval -3.472 to 0.340 | hours x mmol/L | |
| Change in Area Under the Concentration-time Curve of Blood Glucose (AUCglucose) | Placebo | 1.008 | 95% Confidence Interval -0.661 to 2.676 | hours x mmol/L | |
| Change in Average Diastolic Blood Pressure (DBP) | Relacorilant | 24-hour Average | -3.3 | 95% Confidence Interval -6.1 to -0.5 | mm Hg |
| Change in Average Diastolic Blood Pressure (DBP) | Placebo | 24-hour Average | -1.4 | 95% Confidence Interval -3.8 to 0.9 | mm Hg |
| Change in Average Diastolic Blood Pressure (DBP) | Relacorilant | Daytime Average | -3.1 | 95% Confidence Interval -6.0 to -0.1 | mm Hg |
| Change in Average Diastolic Blood Pressure (DBP) | Placebo | Daytime Average | -1.0 | 95% Confidence Interval -3.5 to 1.6 | mm Hg |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relacorilant | 68 | |
| Overall Study | STARTED | Placebo | 69 | |
| Overall Study | COMPLETED | Relacorilant | 43 | |
| Overall Study | COMPLETED | Placebo | 61 | |
| Overall Study | NOT COMPLETED | Relacorilant | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 8 |
Source ClinicalTrials.gov
Adverse events102
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 | Abdominal pain upper | Gastrointestinal disorders | Relacorilant | 14 | 68 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 3 | 69 | |
| other | Nausea | Gastrointestinal disorders | Relacorilant | 13 | 68 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 8 | 69 | |
| other | Abdominal pain | Gastrointestinal disorders | Relacorilant | 12 | 68 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 69 | |
| other | Diarrhoea | Gastrointestinal disorders | Relacorilant | 9 | 68 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 69 | |
| other | Vomiting | Gastrointestinal disorders | Relacorilant | 6 | 68 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 2 | 69 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relacorilant | 1 | 68 |
| Total, all-cause mortality | Placebo | 0 | 69 |
| Total, other adverse events | Relacorilant | 65 | 68 |
| Total, other adverse events | Placebo | 60 | 69 |
| Total, serious adverse events | Relacorilant | 15 | 68 |
| Total, serious adverse events | Placebo | 4 | 69 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Relacorilant vs Placebo: Number of Patients With HbA1c ≥6.5% at Baseline Who Achieved HbA1c <6.5% | Trial comparisons |
| Relacorilant vs Placebo: Number of Patients With Any Dose Decrease in Antihypertensive Medication | Trial comparisons |
| Relacorilant vs Placebo: Number of Patients With DM Who Achieved 2-hour oGTT Glucose <140 mg/dL | Trial comparisons |
| Relacorilant vs Placebo: Number of Patients With Any Dose Decrease in Diabetes Medication | Trial comparisons |
| Relacorilant vs Placebo: Number of Patients With Any Dose Increase or Switch in Diabetes Medication | Trial comparisons |
| Relacorilant vs Placebo: Number of Patients With 1 or More Treatment-emergent Adverse Events (TEAEs) as Graded by CTCAE v5.0. | Trial comparisons |
| Relacorilant vs Placebo: Number of Patients With a Reduction in 24-hour Average SBP by ≥5 mm Hg | Trial comparisons |
| Relacorilant vs Placebo: Number of Patients With Any Dose Increase or Switch in Antihypertensive Medication | Trial comparisons |
| Relacorilant vs Placebo: deaths from any cause | Trial comparisons |
| Relacorilant vs Placebo: Number of Patients With IGT Who Achieved 2-hour oGTT Glucose <140 mg/dL | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04308590
GET https://conductscience.org/api/trials/v1/NCT04308590/results?page=2