Trial · NCT05633953
Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
NCT05633953, Completed, RECORDATI GROUP; results first posted 2025-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome. Trials, record NCT05633953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05633953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome
- NCT number
- NCT05633953
- Status
- Completed
- Enrollment
- 103 participants, actual
- Lead sponsor
- RECORDATI GROUP
- Conditions
- Cushing's Syndrome
- Interventions
- Osilodrostat
- First posted
- 2022-12-01
- Last updated
- 2025-02-10
- Results first posted
- 2025-02-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effectiveness of Osilodrostat | at week 12 | Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN) |
| Secondary | Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC) | at weeks 18, 24, 36, 48, 60, and 72 | Proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN) by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up. |
| Secondary | Long Term Effects of Osilodrostat on Morning Serum Cortisol | At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72 | Proportion of patients with normal measures of morning serum cortisol \[≤ upper normal limit (ULN)\] by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up. |
| Secondary | Long-term Effects of Osilodrostat on Composite Cortisol Measure | At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72 | Proportion of patients with normal response of composite cortisol (salivary cortisol, urinary cortisol and morning serum cortisol) \[≤ upper normal limit (ULN)\] by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effectiveness of Osilodrostat | at week 12 | Patients demonstrating a complete mUFC response at Week 12 with non-missing values | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC) | at weeks 18, 24, 36, 48, 60, and 72 | Of all the patients, only the ones with non missing data at each visit were considered to analyse the variation on mUFC | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Long Term Effects of Osilodrostat on Morning Serum Cortisol | At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72 | The analysis was done only on patients with no-missing data at each visit | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Long-term Effects of Osilodrostat on Composite Cortisol Measure | At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72 | Only the subjects with no-missing data at each visit were considered in the analysis | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effectiveness of Osilodrostat | Osilodrostat_ITT | 23 | Participants | ||
| Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC) | Osilodrostat | week 18 | 7 | Participants | |
| Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC) | Osilodrostat | week 24 | 12 | Participants | |
| Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC) | Osilodrostat | week 36 | 6 | Participants | |
| Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC) | Osilodrostat | week 48 | 6 | Participants | |
| Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC) | Osilodrostat | week 60 | 6 | Participants | |
| Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC) | Osilodrostat | week 72 | 6 | Participants | |
| Long Term Effects of Osilodrostat on Morning Serum Cortisol | Osilodrostat_ITT | Baseline | 18 | Participants | |
| Long Term Effects of Osilodrostat on Morning Serum Cortisol | Osilodrostat_ITT | week 4 | 19 | Participants | |
| Long Term Effects of Osilodrostat on Morning Serum Cortisol | Osilodrostat_ITT | week 8 | 6 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Osilodrostat | 103 | |
| Overall Study | COMPLETED | Osilodrostat | 43 | |
| Overall Study | NOT COMPLETED | Osilodrostat | 60 |
Source ClinicalTrials.gov
Adverse events33
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 | Asthenia | General disorders | Osilodrostat | 14 | 103 | |
| other | Oedema peripheral | General disorders | Osilodrostat | 6 | 103 | |
| other | Adrenal insufficiency | Endocrine disorders | Osilodrostat | 29 | 103 | |
| other | Diarrhoea | Gastrointestinal disorders | Osilodrostat | 13 | 103 | |
| other | Nausea | Gastrointestinal disorders | Osilodrostat | 12 | 103 | |
| other | Abdominal pain | Gastrointestinal disorders | Osilodrostat | 7 | 103 | |
| other | Constipation | Gastrointestinal disorders | Osilodrostat | 6 | 103 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Osilodrostat | 18 | 103 | |
| other | Acute kidney injury | Renal and urinary disorders | Osilodrostat | 8 | 103 | |
| other | Hypertension | Vascular disorders | Osilodrostat | 6 | 103 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Osilodrostat | 30 | 103 |
| Total, other adverse events | Osilodrostat | 87 | 103 |
| Total, serious adverse events | Osilodrostat | 52 | 103 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05633953
GET https://conductscience.org/api/trials/v1/NCT05633953/results?page=2