A Phase 4 interventional study of osilodrostat and osilodrostat and cabergoline in Cushing Disease Due to Increased ACTH Secretion, sponsored by University of Basrah. Enrolling by invitation at 5 sites in Iraq. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University of Basrah · Phase 4, Interventional, and Treatment
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?
In this study, adult patients with active CD (with or without previous TSS or radiotherapy) will be enrolled. Investigators will start treatment for all with Osilodrostat using up-titrating doses on bi-weekly bases. Then the patients will be randomized into two groups. For the first group, carbergoline with escalating doses will be added. For the second group, the patients will continue osilodrostat treatment with increasing doses. Through the period of the study interventions, the patients will be followed clinically, and biochemical looking for treatment related efficacy and safety.
64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.
This study's planned enrollment of 50 is above the median of 44 across 40 interventional studies indexed under Pituitary ACTH Hypersecretion.
Browse Pituitary ACTH Hypersecretion studies →University of Basrah is the lead sponsor of 8 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Osilodrostat up to 15 mg daily
Drug: osilodrostat
Osilodrostat up to 5 mg daily plus Cabergoline up to 3 mg weekly
Drug: osilodrostat and cabergoline
1 mg (pill) twice daily for two weeks, titrated to 2.5 mg (5 mg pill divided) twice daily for two weeks, then 7.5 (half 5 mg pill and 5 mg pill) for four weeks, then 10 mg (5 mg pill twice daily) for four weeks, then 15 mg (5 mg pill thrice daily).
Drug pages: Osilodrostat · Cabergoline
1 mg (pill) twice daily for two weeks, titrated to 2.5 mg (5 mg pill divided) twice daily for two weeks, then Add: Cabergoline 0.5 mg twice weekly for four weeks, titrated to 1 mg twice weekly for four weeks, then 1 mg thrice weekly.
Changes in serum cortisol
serum cortisol (8-9 am and 6-7 pm).
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Number of patients achieved serum cortisol (7-12 Mg/dL)
measurement of 8-9 am serum cortisol.
Time frame: 4 weeks, 8 weeks, 12 weeks, 24, weeks, 36 weeks, and 48 weeks.
Changes in Cushing 's Quality-of-Life questionnaire 12-items (CushingQoL) score for the patients quality of life.
Changes in CushingQoL (12 items) questionnaire. The lowest score is 12 and highest score is 60. The highest the score, the better life quality and clinical improvement in Cushing syndrome.
Time frame: At 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in the patients' Body weight (kg)
measurement of the patients' body weight using scale in the early morning and fasting, bare feet, light clothes, using electronic scale.
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in the patients' Blood pressure (increase or decrease) and increase or decrease requirements for blood pressure lowering medications.
Measurement of the patients' blood pressure (SBP/DBP mmHg) using standard electronic arm cuff blood pressure machine.
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in HbA1c (%)
measurement of the patients HbA1c % using BioRad D10
Time frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Assessment of clinical hyperandrogenic features (acne and hirsutism), whether increase or decrease for female patients
Acne will be assessed by clinical examination and reported as improved or increased. Hirsutism will be assessed using the changes in the modified Ferrimann-Gallwey (mFG) score (0 - 36), the highest the score, the more severe hirsutism.
Time frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in plasma ACTH
measurement of early morning plasma ACTH (pg/ml)
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in serum dehydroepiandrosterone acetate (Mg/dl)
measurement of serum dehydroepiandrosterone acetate (Mg/dl)
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in the corrected QT interval on electrocardiograph (ECG).
Performance of ECG for assessment and record of the c QT interval.
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in serum potassium
measurement of serum potassium
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Development of symptoms of hypoadrenalism
Development of symptoms of hypoadrenalism in the form of (anorexia, nausea, vomiting, fatigue, abdominal pain, dizziness, and hypotension)
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Number of patients will have morning serum cortisol less than (5 Mg/dl)
measurement of serum cortisol in the morning and fasting state.
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Other drug related side effects
Side effects of Osilodrostat and cabergoline
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Plan to share: Yes — Only IPD used in the results publication.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months and ending 3 years after the publication of results.
Started May 2026 (actual). Primary completion is estimated for Jun 2028, 25 months after the start.
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Studies of the drugs tested here: Osilodrostat · Cabergoline
Pituitary ACTH Hypersecretion →
University of Basrah