Testing Osilodrostat with Cabergoline in Cushing's Disease
Compares osilodrostat with and without cabergoline in adults with Cushing's disease.
Plain-language title generated from the registry record
Registry title: Combination Osilodrostat and Cabergoline in Cushing's Disease
Key facts
- Where
- Basra, Karbala, Mosul, Najaf, and Nasiriyah, IraqSee the 5 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with active Cushing's disease caused by a pituitary tumour. It compares osilodrostat alone with osilodrostat plus cabergoline.
- Age
- 18 to 70 years
- Sex
- Men and women
- Disease stage
- Active Cushing's disease, not yet treated or already treated with pituitary surgery and/or radio surgery. Active disease must be confirmed by two repeated tests. ACTH is inappropriately high. The desmopressin test shows a positive ACTH response. MRI shows a pituitary adenoma.
- Earlier treatment
- Can be untreated, or can have had pituitary surgery (TSS) and/or radio surgery.
- Biomarker or test result
- Active disease confirmed twice by the 1-mg overnight dexamethasone suppression test and late night salivary cortisol. Inappropriately raised ACTH. Positive ACTH response to the desmopressin stimulation test.
Main reasons for not taking part
- Severe liver problems (Child-Pugh C)
- Pregnancy
Read by machine on 13 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07603466, who can take part
Where in Iraq
- Faiha Specialized Diabetes, Endocrine, and Metabolism CenterBasra, IraqNo longer taking part
- Al-Hassan Metabolism Endocrine and Diabetes CenterKarbala, IraqNo longer taking part
- Al-Waffa Specialized Center for Diabetes and EndocrinologyMosul, IraqNo longer taking part
- Najaf Specialized Diabetes and Endocrine CenterNajaf, IraqNo longer taking part
- Thi-Qar Specialized Diabetes, Endocrine and Metabolism CenterNasiriyah, IraqNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Basrah
- Trial code
- NCT07603466
- Record updated
- 22 May 2026
- Original description
Cushing disease remains a challenging endocrine disorder in which persistent or recurrent hypercortisolism often requires medical therapy after surgery or when surgery is not feasible. Combination medical therapy has emerged as a rational strategy to improve biochemical control through complementary mechanisms while potentially reducing treatment escape and dose-related toxicity. Cabergoline exerts pituitary D2-receptor-mediated inhibition of ACTH secretion and may provide partial cortisol control in selected patients, although treatment escape and variable durability remain important limitations. Osilodrostat is a potent 11β-hydroxylase inhibitor that produces rapid and often substantial reductions in cortisol secretion, with clinical improvement in metabolic and cardiovascular features of hypercortisolism. The osilodrostat-cabergoline combination is mechanistically attractive because it pairs central ACTH suppression with peripheral blockade of cortisol synthesis, but published evidence remains limited to small real-world experiences and does not yet define optimal sequencing, dosing, or long-term benefit. Safety considerations include adrenal insufficiency from overtreatment, osilodrostat-associated hypertension from mineralocorticoid precursor accumulation, and hyperandrogenism due to steroid precursor shunting.Read full original descriptionShow less
Combination Osilodrostat and Cabergoline Versus Osilodrostat Alone in Cushing's Disease in Iraq: Assessment of Efficacy and Safety
Cushing disease remains a challenging endocrine disorder in which persistent or recurrent hypercortisolism often requires medical therapy after surgery or when surgery is not feasible. Combination medical therapy has emerged as a rational strategy to improve biochemical control through complementary mechanisms while potentially reducing treatment escape and dose-related toxicity. Cabergoline exerts pituitary D2-receptor-mediated inhibition of ACTH secretion and may provide partial cortisol control in selected patients, although treatment escape and variable durability remain important limitations. Osilodrostat is a potent 11β-hydroxylase inhibitor that produces rapid and often substantial reductions in cortisol secretion, with clinical improvement in metabolic and cardiovascular features of hypercortisolism. The osilodrostat-cabergoline combination is mechanistically attractive because it pairs central ACTH suppression with peripheral blockade of cortisol synthesis, but published evidence remains limited to small real-world experiences and does not yet define optimal sequencing, dosing, or long-term benefit. Safety considerations include adrenal insufficiency from overtreatment, osilodrostat-associated hypertension from mineralocorticoid precursor accumulation, and hyperandrogenism due to steroid precursor shunting.
Combination medical therapy in Cushing disease is a promising individualized approach, and the osilodrostat-cabergoline pairing is biologically plausible and potentially effective, but current literature is insufficient to support firm recommendations regarding efficacy, safety, or patient selection.
The study aims to evaluate whether a combination can result in rapid, more control of Cushing's disease (clinically and biochemically)? Can cabergoline reduces Osilodrostat dose requirement, reduces Osilodrostat related mineralocorticoid and hyperandrogenism side effects?
Inclusion: Cushing's disease: Not treated or received treatment (TSS and/or radio surgery). And; Active disease confirmed with repeated two biochemical tests (1-mg overnight dexamethasone suppression test and late night salivary cortisol), And; Inappropriate ACTH elevation, And; Positive ACTH response to desmopressin stimulation test, And; MRI finding of pituitary adenoma.
Exclusion: Severe hepatic impairment (Child-Pugh C); Pregnancy.