Cushing Disease Due to Increased ACTH SecretionPhase 4COSCA-ECDNCT07603466
Combination Osilodrostat and Cabergoline in Cushing's Disease
A Phase 4 study testing osilodrostat and osilodrostat and cabergoline in people with Cushing Disease Due to Increased ACTH Secretion, run by University of Basrah at 5 sites in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cushing Disease Due to Increased ACTH Secretion
- What is being tested?
- osilodrostat and osilodrostat and cabergoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesIraq
- Study dates
- 11 May 2026to Aug 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Severe hepatic impairment (Child-Pugh C).
- Pregnancy.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Iraq5 sites
Faiha Specialized Diabetes, Endocrine, and Metabolism Center
Basra, 61001
Al-Hassan Metabolism Endocrine and Diabetes Center
Karbala
Al-Waffa Specialized Center for Diabetes and Endocrinology
Mosul
Najaf Specialized Diabetes and Endocrine Center
Najaf
Thi-Qar Specialized Diabetes, Endocrine and Metabolism Center
Nasiriyah
About this study
Official title: 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?
Read the detailed description
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.
- Being tested
- osilodrostat, osilodrostat and cabergoline
- Keywords
- Cushing's disease, Osilodrostat, cabergoline, adrenal insufficiency, hypertension, hypokalemia, Hyperandrogenism, serum cortisol, serum dehydroepiandrosterone acetate, adrenocorticotrophic hormone, QT interval
- Medical subject headings
- Pituitary ACTH Hypersecretion, Adrenal Insufficiency, Hypertension, Hypokalemia, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osilodrostatDrug
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).
osilodrostat and cabergolineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Osilodrostat alone | Active comparator | Osilodrostat up to 15 mg daily Receives: Drug: osilodrostat |
| Combination osilodrostat and cabergoline | Active comparator | Osilodrostat up to 5 mg daily plus Cabergoline up to 3 mg weekly Receives: Drug: osilodrostat and cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum cortisol
serum cortisol (8-9 am and 6-7 pm).
Measured: 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.
Measured: 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.
Measured: At 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in plasma ACTH
measurement of early morning plasma ACTH (pg/ml)
Measured: 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)
Measured: 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.
Measured: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in serum potassium
measurement of serum potassium
Measured: 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)
Measured: 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.
Measured: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start11 May 2026
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cushing Disease Due to Increased ACTH SecretionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Basrah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haider Ayad Alidrisi, University of Basrah
- Investigators
- Haider A Alidrisi, Principal investigator, Univeristy of basrah, Faiha Specialized Diabetes, Endocrine, and Metabolism CenterIbrahim H Hussein, MD, Principal investigator, Univeristy of basrah, Faiha Specialized Diabetes, Endocrine, and Metabolism CenterAbbas A Mansour, Study chair, Univeristy of basrah, Faiha Specialized Diabetes, Endocrine, and Metabolism Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603466
- Sponsor's protocol ID
- 05/13/26
- Acronym
- COSCA-ECD
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication.
Publications
Ferriere A, Cortet C, Chanson P, Delemer B, Caron P, Chabre O, Reznik Y, Bertherat J, Rohmer V, Briet C, Raingeard I, Castinetti F, Beckers A, Vroonen L, Maiter D, Cephise-Velayoudom FL, Nunes ML, Haissaguerre M, Tabarin A. Cabergoline for Cushing's disease: a large retrospective multicenter study. Eur J Endocrinol. 2017 Mar;176(3):305-314. doi: 10.1530/EJE-16-0662. Epub 2016 Dec 22.
PubMed 28007845Giustina A, Uygur MM, Frara S, Barkan A, Biermasz NR, Chanson P, Freda P, Gadelha M, Haberbosch L, Kaiser UB, Lamberts S, Laws E, Nachtigall LB, Popovic V, Schilbach K, Lely AJV, Wass JAH, Melmed S, Casanueva FF. Medical management pathways for Cushing's disease in pituitary tumors centers of excellence (PTCOEs). Pituitary. 2025 Jan 29;28(1):23. doi: 10.1007/s11102-024-01485-x.
PubMed 39881009Gadelha M, Bex M, Feelders RA, Heaney AP, Auchus RJ, Gilis-Januszewska A, Witek P, Belaya Z, Yu Y, Liao Z, Ku CHC, Carvalho D, Roughton M, Wojna J, Pedroncelli AM, Snyder PJ. Randomized Trial of Osilodrostat for the Treatment of Cushing Disease. J Clin Endocrinol Metab. 2022 Jun 16;107(7):e2882-e2895. doi: 10.1210/clinem/dgac178.
PubMed 35325149Vilar L, Naves LA, Machado MC, Bronstein MD. Medical combination therapies in Cushing's disease. Pituitary. 2015 Apr;18(2):253-62. doi: 10.1007/s11102-015-0641-x.
PubMed 25647330
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Osilodrostat and Cabergoline Versus Osilodrostat Alone in Cushing's Disease in Iraq: Assessment of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07603466
- Acronym / sponsor ID
- COSCA-ECD / 05/13/26
- Keywords
- Cushing's disease, Osilodrostat, cabergoline, adrenal insufficiency, hypertension, hypokalemia, Hyperandrogenism, serum cortisol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of BasrahUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osilodrostat alone | Active comparator | Drug: osilodrostatOsilodrostat up to 15 mg daily |
| Combination osilodrostat and cabergoline | Active comparator | Drug: osilodrostat and cabergolineOsilodrostat up to 5 mg daily plus Cabergoline up to 3 mg weekly |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Severe hepatic impairment (Child-Pugh C).
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| osilodrostat1 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 | Osilodrostat alone |
| osilodrostat and cabergoline1 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. | Drug | Combination osilodrostat and cabergoline |
Primary outcome
Changes in serum cortisol
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
serum cortisol (8-9 am and 6-7 pm).
Number of patients achieved serum cortisol (7-12 Mg/dL)
Time frame: 4 weeks, 8 weeks, 12 weeks, 24, weeks, 36 weeks, and 48 weeks.
measurement of 8-9 am serum cortisol.
Changes in Cushing 's Quality-of-Life questionnaire 12-items (CushingQoL) score for the patients quality of life.
Time frame: At 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
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.
10 secondary outcomes
Changes in the patients' Body weight (kg)
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.
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in HbA1c (%)
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
Time frame: At 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in plasma ACTH
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)
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).
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Changes in 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
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)
Time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 28007845Ferriere A, Cortet C, Chanson P, Delemer B, Caron P, Chabre O, Reznik Y, Bertherat J, Rohmer V, Briet C, Raingeard I, Castinetti F, Beckers A, Vroonen L, Maiter D, Cephise-Velayoudom FL, Nunes ML, Haissaguerre M, Tabarin A. Cabergoline for Cushing's disease: a large retrospective multicenter study. Eur J Endocrinol. 2017 Mar;176(3):305-314. doi: 10.1530/EJE-16-0662. Epub 2016 Dec 22.
- Background: PubMed 39881009Giustina A, Uygur MM, Frara S, Barkan A, Biermasz NR, Chanson P, Freda P, Gadelha M, Haberbosch L, Kaiser UB, Lamberts S, Laws E, Nachtigall LB, Popovic V, Schilbach K, Lely AJV, Wass JAH, Melmed S, Casanueva FF. Medical management pathways for Cushing's disease in pituitary tumors centers of excellence (PTCOEs). Pituitary. 2025 Jan 29;28(1):23. doi: 10.1007/s11102-024-01485-x.
- Background: PubMed 35325149Gadelha M, Bex M, Feelders RA, Heaney AP, Auchus RJ, Gilis-Januszewska A, Witek P, Belaya Z, Yu Y, Liao Z, Ku CHC, Carvalho D, Roughton M, Wojna J, Pedroncelli AM, Snyder PJ. Randomized Trial of Osilodrostat for the Treatment of Cushing Disease. J Clin Endocrinol Metab. 2022 Jun 16;107(7):e2882-e2895. doi: 10.1210/clinem/dgac178.
- Background: PubMed 25647330Vilar L, Naves LA, Machado MC, Bronstein MD. Medical combination therapies in Cushing's disease. Pituitary. 2015 Apr;18(2):253-62. doi: 10.1007/s11102-015-0641-x.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haider A Alidrisi principal investigator
Univeristy of basrah, Faiha Specialized Diabetes, Endocrine, and Metabolism Center
Ibrahim H Hussein, MD principal investigator
Univeristy of basrah, Faiha Specialized Diabetes, Endocrine, and Metabolism Center
Abbas A Mansour study chair
Univeristy of basrah, Faiha Specialized Diabetes, Endocrine, and Metabolism Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing osilodrostat and osilodrostat and cabergoline in people with Cushing Disease Due to Increased ACTH Secretion, run by University of Basrah at 5 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum cortisol (time frame: At 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07603466, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.