Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome

Exclusion Criteria

• •1. Previously treated with osilodrostat less than 12 weeks prior to start of screening
• •2. Known hypersensitivity to osilodrostat
• •3. Presence of any severe and/or uncontrolled medical condition or other conditions that could affect participation in the study
• •4. Participants who are scheduled for a surgery to treat CS within 32 weeks of randomisation to the study drug
• •5. 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)
• •6. History of cyclic Cushing's Syndrome with fluctuating clinical manifestations
• •7. Participants with pseudo-CS
• •8. 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)
• •9. Pituitary radiation therapy within 3 years of screening
• •10. Ectopic ACTH syndrome or adrenocortical carcinoma with a life expectancy of \<3 years or receiving chemotherapy
• •11. Having received prior mitotane treatment
• •12. Participants who are shift workers or have conditions that can affect the measurement of late night salivary cortisol (LNSC) or the LDDST
• •13. Poorly controlled diabetes mellitus with a baseline HbA1c \> 10.5%
• •14. Poorly controlled BP defined as: Average SBP ≥ 170 or average DBP ≥ 110 mmHg as measured by the 24h ABPM
• •15. Participants who are hypothyroid and not on adequate replacement therapy
• •16. History of major surgery/surgical therapy for any cause within 1 month before entering the study.
• •18. Total bilirubin \> 1.5 x ULN and ALT or AST \> 3 x ULN
• •19. Participation in any clinical investigation within 4 weeks prior to screening or longer if required by local regulation (Use of an investigational drug within 1 month prior to dosing)
• •20. Occurrence of any significant acute illness within the three weeks prior to dosing/randomisation
• •21. Female participants who are pregnant, intending to become pregnant or breastfeed during the study or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
• •22. Women of childbearing potential (WOCBP) who are unwilling to use highly effective contraception methods
• •23. Potentially unreliable or vulnerable participants (e.g. person kept in detention) and those judged by the Investigator to be unsuitable for the study