Trial · NCT06430528
A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
NCT06430528, Recruiting, University of Michigan
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement. Trials, record NCT06430528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06430528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement
- NCT number
- NCT06430528
- Status
- Recruiting
- Enrollment
- 12 participants, estimated
- Lead sponsor
- University of Michigan
- Conditions
- Endogenous Cushing Syndrome, Adrenal Insufficiency, Hypercortisolism
- Interventions
- Osilodrostat
- First posted
- 2024-05-28
- Last updated
- 2026-09-09
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of participants who experience an adrenal insufficiency event during Phase 1 (titration phase) | Through phase 1, approximately 24 weeks | based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy |
| Secondary | Correlation between AM cortisol and 11OHA4 measurements | Up to end of study, approximately 48 weeks | compare biomarkers measured by mass spectrometry. This may be calculated Upon 12 participants completing phase 1 or at the end of the study, whichever comes first. |
| Secondary | Rate of adrenal insufficient episodes per patient per year | Up to end of phase 2 (approximately 48 weeks) | based on evidence of hypotension (systolic BP \<90 mmHg) and/or hypoglycemia (glucose \<45 mg/dL) with antecedent symptoms (examples: anorexia, nausea, abdominal pain, orthostasis) and with a resolution of signs upon receiving rescue glucocorticoid therapy |
| Secondary | Frequency of cortisol withdrawal symptoms | Up to end of phase 2 (approximately 48 weeks) | Based on patient-reported outcomes |
| Secondary | Change in weight | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic measurements |
| Secondary | Change in diastolic blood pressure | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic measurements |
| Secondary | Change in systolic blood pressure | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic measurements |
| Secondary | Mean change in HgbA1c for participant with HgbA1c > 6.4% at entry. | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic measurements |
| Secondary | Change in number of concomitant medications | Baseline, end of phase 2 (approximately 48 weeks) | Based on clinic notes, total number of medications used to treat Cushing syndrome comorbidities |
| Secondary | Adrenal Insufficiency Assessment Questionnaire scores | Up to end of study, approximately 48 weeks | Custom questionnaire for adrenal insufficiency- 4 Likert questions with scores ranging from 4-20. Higher scores indicate worse symptoms. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT06430528
GET https://conductscience.org/api/trials/v1/NCT06430528/registered