Mild Autonomous Cortisol SecretionPhase 1NCT07649317
Ketoconazole Effects on the Daily Cortisol Rhythm in Mild Autonomous Cortisol Secretion
A Phase 1 study testing Ketoconazole in people with Mild Autonomous Cortisol Secretion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Cortisol is a hormone in the blood. Cortisol levels normally go down at night and up in the morning. Mild autonomous cortisol secretion (MACS) is a disease in which the body makes too much cortisol. MACS can cause high blood pressure, diabetes, and/or weight gain. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mild Autonomous Cortisol Secretion
- What is being tested?
- Ketoconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to 31 Dec 2027
- Phase
- Phase 1
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Aged 18 years or older.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Agreement to adhere to Lifestyle Considerations throughout the study.
- Subjects with Mild Autonomous Cortisol Secretion (MACS):
- Co-enrollment in protocol 19DK0066.
Show all 18Show fewer
- Abnormal low-dose overnight dexamethasone suppression test (morning serum cortisol >1.8 mcg/dL following 1 mg oral dexamethasone between 2300-0000h the evening prior)
- One or more >=1 cm adrenal nodule(s) on one or both adrenal glands on CT or MRI
- One normal 24-hour urine free cortisol value (per the reference range of the assay used).
- One morning plasma ACTH value <10 pg/mL.
- Healthy volunteers:
- In good general health as evidenced by medical history and physical examination; and in a stable state of health without ongoing acute/temporary illness per the clinical judgment of the investigator.
- Normal low-dose overnight dexamethasone suppression test (morning serum cortisol <=1.8 mcg/dL following 1 mg oral dexamethasone between 2300-0000h the evening prior)
- Matching a participant with MACS who has completed testing in regard to:
- Age: Birth year within 5 years of that of the participant with MACS.
- Sex
- BMI (kg/m2) category: <18.5 (underweight); 18.5-24.9 (normal weight); 25-29.9 (overweight); 30-34.9 (obesity class 1); 35-39.9 (obesity class 2); >=40 (obesity class 3).
- For women: menopausal status as judged by absence of menses for one year and FSH>15 mIU/mL.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability to comply with all study procedures and visits.
- Inability of subject to understand or to sign a written informed consent document.
- Pregnancy or breastfeeding.
- Use of estrogen-containing oral contraceptives or oral estrogen therapy within 6 weeks before inpatient admission, due to possible increases in serum corticosteroid-binding globulin, and thereby total cortisol.
- Use of medications within 2 weeks before inpatient admission that can block glucocorticoid production or action: ketoconazole (systemic), levoketoconazole, metyrapone, osilodrostat, mifepristone.
Show all 32Show fewer
- Use of oral, injectable, or inhaled glucocorticoids (unless intermittent, for symptomatic asthma) within the year before inpatient admission. Use of topical non-hydrocortisone containing potent glucocorticoids on more than 36 square inches within six months before inpatient admission.
- Anemia (hemoglobin <13.7 g/dL for males, <11.2 g/dL for females).
- Daily alcohol risk use (>2 standard drinks per day by self-report during screening visit).
- Severely uncontrolled diabetes mellitus (HbA1c >9.0%).
- Highly irregular sleep schedule in the week leading up to inpatient admission (e.g. shift work).
- Any contraindication to intravenous catheter use.
- Previous participation in this protocol.
- Any condition that in the opinion of the Investigator would jeopardize the participant s appropriate participation in this study.
- Any hematology or chemistry screening laboratory value drawn at screening that the Investigator deems clinically significant for exclusion.
- Subjects with Mild Autonomous Cortisol Secretion (MACS):
- Evidence of hyperaldosteronism, which must have been ruled out with serum aldosterone and plasma renin activity measurements if the participant has a history of hypertension or hypokalemia, per standard clinical care.
- Evidence of pheochromocytoma, which must have been ruled out with plasma or 24-hour urine metanephrines if an unenhanced adrenal nodule is >10 HU, per standard clinical care.
- Known allergy or hypersensitivity to ketoconazole.
- Significant liver disease or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3xULN, and/or total bilirubin >1.5xULN during Screening.
- Prolonged QTc interval (>500 msec) on screening ECG.
- Use of medications in the 2 weeks before inpatient admission that can:
- Prolong QT when combined with ketoconazole (KTZ):
- -- dofetilide, quinidine, pimozide, cisapride, methadone, disopyramide, dronedarone, ranolazine.
- Cause toxicity from increased concentration due to KTZ-induced CYP3A4 inhibition:
- --methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, felodipine, nisoldipine, ranolazine, tolvaptan, eplerenone, lovastatin, simvastatin and colchicine.
- Inhibit CYP3A4 and increase KTZ bioavailability:
- -- ritonavir, darunavir, fosamprenavir.
- Induce CYP3A4 and decrease KTZ bioavailability:
- Isoniazid, rifabutin, rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine.
- Inability to pause, for 24 hours, use of medication that reduces KTZ absorption: proton pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole) and H2 antagonists (cimetidine, famotidine, nizatidine).
- Inability to pause, for 3 hours, use of short-acting acid neutralizers that reduce KTZ absorption, e.g. aluminum hydroxide (acceptable if taken >=1 hour before or >=2 hours after KTZ).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Ketoconazole Effects on Cortisol Circadian Rhythm in Mild Autonomous Cortisol Secretion: A Pilot Study
Background:
Cortisol is a hormone in the blood. Cortisol levels normally go down at night and up in the morning. Mild autonomous cortisol secretion (MACS) is a disease in which the body makes too much cortisol. MACS can cause high blood pressure, diabetes, and/or weight gain. Researchers think these problems may be caused by higher cortisol levels at night.
Read more
Objective:
To compare daily cortisol levels in people with MACS with those in healthy people. Also, to test a drug (ketoconazole) that may help lower cortisol levels in people with MACS.
Eligibility:
People aged 18 years and older with MACS. Healthy volunteers are also needed.
Design:
Participants with MACS will have a 2-night stay in the hospital.
Day 1: A thin tube called a catheter will be inserted into a vein in the arm. Blood will be collected through the catheter every 2 hours starting at 8 PM. Participants will begin a 24-hour urine collection. Saliva will be collected every 6 hours for 24 hours.
Day 2: Participants will take 2 tablets of the study drug ketoconazole with their evening meal. Blood will be collected via the catheter at regular intervals throughout the night.
Day 3: Participants will leave the hospital in the morning.
Healthy volunteers will be screened with a physical exam and blood tests. They will be tested to make sure they do not have MACS. To do this, they will take a drug (dexamethasone) at 11 PM on a day they choose; then they will return the next morning for a blood test.
Healthy volunteers will have a 1-night stay in the hospital. They will have blood, urine, and saliva collected for 24 hours.
Read the detailed description
Study Description:
This study will compare the circadian rhythm of serum cortisol in subjects with Mild Autonomous Cortisol Secretion (MACS) and healthy volunteers (HVs). At the end of 24-hour baseline sampling, participants with MACS will receive a single dose of ketoconazole (KTZ) and undergo continued serial sampling to assess its effect on cortisol production. We hypothesize that subjects with MACS have decreased diurnal variability of serum cortisol, leading to relative excess in the evening and early overnight hours. We also hypothesize that a single dose of KTZ lowers cortisol enough to restore a near-normal diurnal pattern.
Objectives:
Primary Objective:
To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched HVs.
Secondary Objective:
To determine the degree of serum cortisol reduction induced by a single dose of 400 mg KTZ in participants with MACS.
Exploratory Objectives:
- To define the time to greatest decrease of cortisol after a dose of KTZ;
- To compare serum levels of cortisol precursors in MACS and HVs;
- To assess which steroidogenic enzymes are most affected by KTZ;
- To compare the nadir-to-peak cortisol excursion in MACS and HVs;
- To compare awake and asleep urine cortisol levels in MACS and HVs;
- To assess the correlation of salivary cortisol and cortisone with serum Cortisol.
Endpoints:
Primary Endpoints:
Difference in serum cortisol between MACS and HV at timepoints 1600h, 1800h, 2000h, 2200h, 0000h and 0200h during 24-hour sampling.
Secondary Endpoints:
Absolute and relative reduction of serum cortisol from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours after KTZ.
Exploratory Endpoints:
Time to maximum cortisol reduction after KTZ compared to baseline sampling; serum cortisol precursors during serial sampling before (MACS and HV) and after (MACS only) KTZ dosing; absolute and relative difference in serum cortisol from nadir to peak; urine free cortisol values while awake and asleep; salivary cortisol/cortisone and serum cortisol levels at timepoints 0000h, 0600h, 1200h and 1800h.
- Conditions
- Mild Autonomous Cortisol Secretion
- Being tested
- Ketoconazole
- Keywords
- Cortisol, KETOCONAZOLE, Mild Autonomous Cortisol Secretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoconazoleDrug
Antifungal medication that blocks adrenal steroidogenesis, including cortisol production, at higher doses
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | No intervention | Healthy volunteers, matched to MACS participants by age, sex, BMI and (women only) menopausal status. Will undergo 24-hour sampling to obtain healthy diurnal serum cortisol curves for comparison. |
| Mild autonomous cortisol secretion (MACS) | Experimental | Patients with mild autonomous cortisol secretion (MACS) who will undergo baseline sampling of diurnal cortisol , followed by sampling after a single dose of ketoconazole 400 mg. Receives: Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched healthy volunteers (HV).
Difference in serum cortisol between MACS and HV at timepoints 1600h, 1800h, 2000h, 2200h, 0000h and 0200h during 24-hour sampling.
Measured: Baseline sampling obtained during 24 hours in each participant.
Secondary outcomes (1)
To determine the degree of serum cortisol reduction induced by a single dose of 400 mg ketoconazole (KTZ) in participants with MACS.
Difference in serum cortisol after KTZ compared to baseline sampling during the same timepoints the day prior.
Measured: Baseline sampling for 24 hours followed by post-KTZ sampling for 12 hours in participants with MACS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start27 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Autonomous Cortisol SecretionStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lynnette K Nieman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649317
- Sponsor's protocol ID
- 10002658
- Other IDs
- 002658-DK
- Status last verified
- 27 Aug 2026
- First submitted
- 13 Jun 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be uploaded to a controlled access data repository.
Publications
Fassnacht M, Tsagarakis S, Terzolo M, Tabarin A, Sahdev A, Newell-Price J, Pelsma I, Marina L, Lorenz K, Bancos I, Arlt W, Dekkers OM. European Society of Endocrinology clinical practice guidelines on the management of adrenal incidentalomas, in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2023 Jul 20;189(1):G1-G42. doi: 10.1093/ejendo/lvad066.
PubMed 37318239Debono M, Harrison RF, Chadarevian R, Gueroult C, Abitbol JL, Newell-Price J. Resetting the Abnormal Circadian Cortisol Rhythm in Adrenal Incidentaloma Patients With Mild Autonomous Cortisol Secretion. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3461-3469. doi: 10.1210/jc.2017-00823.
PubMed 28911138Saini J, Singh S, Ebbehoj A, Zhang CD, Nathani R, Fell V, Atkinson E, Achenbach S, Rivard A, Singh R, Grebe S, Bancos I. Steroid Profiling and Circadian Cortisol Secretion in Patients With Mild Autonomous Cortisol Secretion: A Cross-sectional Study. J Clin Endocrinol Metab. 2025 Jan 21;110(2):542-553. doi: 10.1210/clinem/dgae468.
PubMed 38981002
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketoconazole Effects on Cortisol Circadian Rhythm in Mild Autonomous Cortisol Secretion: A Pilot Study
- ClinicalTrials.gov ID
- NCT07649317
- Acronym / sponsor ID
- 10002658
- Conditions
- Mild Autonomous Cortisol Secretion
- Keywords
- Cortisol, KETOCONAZOLE, Mild Autonomous Cortisol Secretion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jun 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.
Background:
Cortisol is a hormone in the blood. Cortisol levels normally go down at night and up in the morning. Mild autonomous cortisol secretion (MACS) is a disease in which the body makes too much cortisol. MACS can cause high blood pressure, diabetes, and/or weight gain. Researchers think these problems may be caused by higher cortisol levels at night.
Objective:
To compare daily cortisol levels in people with MACS with those in healthy people. Also, to test a drug (ketoconazole) that may help lower cortisol levels in people with MACS.
Eligibility:
People aged 18 years and older with MACS. Healthy volunteers are also needed.
Design:
Participants with MACS will have a 2-night stay in the hospital.
Day 1: A thin tube called a catheter will be inserted into a vein in the arm. Blood will be collected through the catheter every 2 hours starting at 8 PM. Participants will begin a 24-hour urine collection. Saliva will be collected every 6 hours for 24 hours.
Day 2: Participants will take 2 tablets of the study drug ketoconazole with their evening meal. Blood will be collected via the catheter at regular intervals throughout the night.
Day 3: Participants will leave the hospital in the morning.
Healthy volunteers will be screened with a physical exam and blood tests. They will be tested to make sure they do not have MACS. To do this, they will take a drug (dexamethasone) at 11 PM on a day they choose; then they will return the next morning for a blood test.
Healthy volunteers will have a 1-night stay in the hospital. They will have blood, urine, and saliva collected for 24 hours.
Detailed description
Study Description:
This study will compare the circadian rhythm of serum cortisol in subjects with Mild Autonomous Cortisol Secretion (MACS) and healthy volunteers (HVs). At the end of 24-hour baseline sampling, participants with MACS will receive a single dose of ketoconazole (KTZ) and undergo continued serial sampling to assess its effect on cortisol production. We hypothesize that subjects with MACS have decreased diurnal variability of serum cortisol, leading to relative excess in the evening and early overnight hours. We also hypothesize that a single dose of KTZ lowers cortisol enough to restore a near-normal diurnal pattern.
Objectives:
Primary Objective:
To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched HVs.
Secondary Objective:
To determine the degree of serum cortisol reduction induced by a single dose of 400 mg KTZ in participants with MACS.
Exploratory Objectives:
- To define the time to greatest decrease of cortisol after a dose of KTZ;
- To compare serum levels of cortisol precursors in MACS and HVs;
- To assess which steroidogenic enzymes are most affected by KTZ;
- To compare the nadir-to-peak cortisol excursion in MACS and HVs;
- To compare awake and asleep urine cortisol levels in MACS and HVs;
- To assess the correlation of salivary cortisol and cortisone with serum Cortisol.
Endpoints:
Primary Endpoints:
Difference in serum cortisol between MACS and HV at timepoints 1600h, 1800h, 2000h, 2200h, 0000h and 0200h during 24-hour sampling.
Secondary Endpoints:
Absolute and relative reduction of serum cortisol from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours after KTZ.
Exploratory Endpoints:
Time to maximum cortisol reduction after KTZ compared to baseline sampling; serum cortisol precursors during serial sampling before (MACS and HV) and after (MACS only) KTZ dosing; absolute and relative difference in serum cortisol from nadir to peak; urine free cortisol values while awake and asleep; salivary cortisol/cortisone and serum cortisol levels at timepoints 0000h, 0600h, 1200h and 1800h.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | No intervention | –Healthy volunteers, matched to MACS participants by age, sex, BMI and (women only) menopausal status. Will undergo 24-hour sampling to obtain healthy diurnal serum cortisol curves for comparison. |
| Mild autonomous cortisol secretion (MACS) | Experimental | Drug: KetoconazolePatients with mild autonomous cortisol secretion (MACS) who will undergo baseline sampling of diurnal cortisol , followed by sampling after a single dose of ketoconazole 400 mg. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Aged 18 years or older.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Agreement to adhere to Lifestyle Considerations throughout the study.
- Subjects with Mild Autonomous Cortisol Secretion (MACS):
Key exclusion criteria (32 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability to comply with all study procedures and visits.
- Inability of subject to understand or to sign a written informed consent document.
- Pregnancy or breastfeeding.
- Use of estrogen-containing oral contraceptives or oral estrogen therapy within 6 weeks before inpatient admission, due to possible increases in serum corticosteroid-binding globulin, and thereby total cortisol.
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 |
|---|---|---|
| KetoconazoleAntifungal medication that blocks adrenal steroidogenesis, including cortisol production, at higher doses | Drug | Mild autonomous cortisol secretion (MACS) |
Primary outcome
To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched healthy volunteers (HV).
Time frame: Baseline sampling obtained during 24 hours in each participant.
Difference in serum cortisol between MACS and HV at timepoints 1600h, 1800h, 2000h, 2200h, 0000h and 0200h during 24-hour sampling.
1 secondary outcome
To determine the degree of serum cortisol reduction induced by a single dose of 400 mg ketoconazole (KTZ) in participants with MACS.
Time frame: Baseline sampling for 24 hours followed by post-KTZ sampling for 12 hours in participants with MACS.
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 31 Aug 2026.
- Background: PubMed 37318239Fassnacht M, Tsagarakis S, Terzolo M, Tabarin A, Sahdev A, Newell-Price J, Pelsma I, Marina L, Lorenz K, Bancos I, Arlt W, Dekkers OM. European Society of Endocrinology clinical practice guidelines on the management of adrenal incidentalomas, in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2023 Jul 20;189(1):G1-G42. doi: 10.1093/ejendo/lvad066.
- Background: PubMed 28911138Debono M, Harrison RF, Chadarevian R, Gueroult C, Abitbol JL, Newell-Price J. Resetting the Abnormal Circadian Cortisol Rhythm in Adrenal Incidentaloma Patients With Mild Autonomous Cortisol Secretion. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3461-3469. doi: 10.1210/jc.2017-00823.
- Background: PubMed 38981002Saini J, Singh S, Ebbehoj A, Zhang CD, Nathani R, Fell V, Atkinson E, Achenbach S, Rivard A, Singh R, Grebe S, Bancos I. Steroid Profiling and Circadian Cortisol Secretion in Patients With Mild Autonomous Cortisol Secretion: A Cross-sectional Study. J Clin Endocrinol Metab. 2025 Jan 21;110(2):542-553. doi: 10.1210/clinem/dgae468.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be uploaded to a controlled access data repository.
Related trials for Mild Autonomous Cortisol Secretion
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
RecruitingPhase 2
Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS
Mild Autonomous Cortisol Secretion (MACS), Autonomous Cortisol Secretion (ACS)
Active, not recruitingPhase 2
Metyrapone for Mild Autonomous Cortisol Secretion (MACS)
Autonomous Cortisol Secretion, Mild Autonomous Cortisol Secretion (MACS)
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.
Lynnette K Nieman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketoconazole in people with Mild Autonomous Cortisol Secretion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 18 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Raven N McGlotten, R.N. ((301) 827-0190, mcglottenr@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the circadian rhythm of serum cortisol in participants with MACS compared to that in matched healthy volunteers (HV). (time frame: Baseline sampling obtained during 24 hours in each participant.). 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 NCT07649317, which also lists 3 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 31 Aug 2026.