ClinicalTrials.gov record NCT07603466

Combination Osilodrostat and Cabergoline in Cushing's Disease

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Combination Osilodrostat and Cabergoline Versus Osilodrostat Alone in Cushing's Disease in Iraq: Assessment of Efficacy and Safety

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.
Age18 years old to 70 years old
SexAll
LocationIraq
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 4 interventional study enrolls adults with active Cushing disease. All participants begin stepwise dose increases of osilodrostat and are then assigned to either continue osilodrostat alone or receive added cabergoline. The study is open-label and follows clinical and biochemical measures, including cortisol and quality-of-life, at several time points through 48 weeks.

What it is studying. The study tests whether combining cabergoline with osilodrostat changes the speed or degree of biochemical and clinical control of Cushing disease, affects the osilodrostat dose needed, and changes osilodrostat-related safety signals (for example mineralocorticoid effects and hyperandrogenism).

What the researchers hope to learn. To compare osilodrostat alone versus osilodrostat plus cabergoline on biochemical control (serum cortisol, ACTH, DHEA‑S), proportion reaching target morning cortisol, patient-reported quality of life (CushingQoL), and safety outcomes (adrenal insufficiency symptoms, potassium, blood pressure, QT interval, and clinical hyperandrogenism).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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?

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • osilodrostat
  • osilodrostat and cabergoline

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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 criteria

  • Severe hepatic impairment (Child-Pugh C).
  • Pregnancy.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

All participants begin osilodrostat with stepwise dose increases on a bi‑weekly schedule; they are then assigned to one of two treatment groups (osilodrostat alone or osilodrostat plus cabergoline with specified dosing limits). Participants attend regular clinic visits over planned time points up to 48 weeks for repeated blood tests (including morning and evening serum cortisol, ACTH, DHEA‑S, and potassium), ECGs to check QT interval, weight and blood pressure measurements, and CushingQoL questionnaires. Female participants will have clinical checks for acne and hirsutism. Study staff will monitor for symptoms of adrenal insufficiency and adjust doses as needed.

How the study is structured. Interventional (Phase 4), open-label treatment study. Participants start osilodrostat with planned dose increases. They are then assigned to one of two treatment groups: osilodrostat alone or osilodrostat plus cabergoline. Clinical visits, blood tests (including morning and evening cortisol), ECGs, and quality-of-life questionnaires are repeated at scheduled intervals up to 48 weeks to monitor effects and safety. The registry is inconsistent about how people are assigned: its structured information says the study is non-randomized with sequential assignment, while its description says patients will be randomized into two groups. Ask the study team which applies.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Cushing Disease Due to Increased ACTH Secretion. Does it apply to my diagnosis?
  • The registry says participants are enrolled by invitation. Who decides who is invited, and how?
  • The listed sites are in Iraq. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
May 11, 2026
Primary completion
June 2028 (estimated)
Study completion
August 2028 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
May 22, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Basrah
Principal investigator
Haider Ayad Alidrisi, Assistant Professor
University of Basrah

Participating sites (5)

  • Faiha Specialized Diabetes, Endocrine, and Metabolism Center

    Basra, 61001 · Iraq

  • Al-Hassan Metabolism Endocrine and Diabetes Center

    Karbala · Iraq

  • Al-Waffa Specialized Center for Diabetes and Endocrinology

    Mosul · Iraq

  • Najaf Specialized Diabetes and Endocrine Center

    Najaf · Iraq

  • Thi-Qar Specialized Diabetes, Endocrine and Metabolism Center

    Nasiriyah · Iraq

Terms used on this page · explanations by MedicalUpdates.ai

MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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