Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome (NCT07247162) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
63 participantsStarted 2026-08
Plain-language summary
Osilodrostat has proven to be a safe and efficacious treatment for patients with CS. Demonstrating normalisation of hypercortisolaemia and in patients with hypertension and/or dysglycaemia clinically relevant and statistically significant reductions in blood pressure and glycaemia. This study aims at providing additional evidence on the safety, efficacy and appropriate dosing of osilodrostat in patients with CS, who have hypertension.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female ≥ 18 years of age
. Able to provide and have provided signed written informed consent prior to study participation
. Diagnosis of endogenous Cushing's Syndrome
. mUFC values from two 24h urinary collections \> ULN and ≤ 2x ULN
. Participants with uncontrolled hypertension on stable doses of BP lowering medications (for at least 4 weeks); qualifying BP measurements by ABPM taken prior to randomisation defined as: Average of 24h ABPM SBP ≥ 135 or DBP ≥ 85 mmHg
. Participants under glucocorticoid replacement therapy can be recruited only if this therapy has been already stopped for at least seven days or 5 half-lives prior to screening, whichever was longer
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the efficacy of osilodrostat on the proportion of participants with normalisation of urinary-free cortisol (UFC)
. Previously treated with osilodrostat less than 12 weeks prior to start of screening
. Known hypersensitivity to osilodrostat
. Presence of any severe and/or uncontrolled medical condition or other conditions that could affect participation in the study
. Participants who are scheduled for a surgery to treat CS within 32 weeks of randomisation to the study drug
. Presence of a known "long term" history of both hypertension and diabetes (defined as both hypertension and diabetes diagnosed \>10 years prior to the initial diagnosis of endogenous CS)
. History of cyclic Cushing's Syndrome with fluctuating clinical manifestations
. Participants with pseudo-CS
. Participants with compression of the optic chiasm due to a macroadenoma or participants at high risk of compression of the optic chiasm (tumour within 2 mm of optic chiasm)