Relacorilant in Patients With Poorly Controlled Type 2 Diabetes and Autonomous Cortisol Secretion

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 1 / Phase 2

Age range

18 years - 75 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

34 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The purpose of this study is to assess the effect and effectiveness of Relacorilant on improving the glucose levels in the blood, thus potentially improving glucose control in patients with hard to control diabetes.

This study involves the use of an investigational drug called Relacorilant. "Investigational" means that the drug has not yet been approved by the U.S. Food \& Drug Administration (FDA) for treating "mild hypercortisolism" in patients with diabetes. Cortisol is a "stress hormone". The excess production of cortisol can rise blood sugar (glucose) levels and worsen diabetes. Those disturbances might be corrected by the study medication Relacorilant to improve the state of your diabetes.

This study will evaluate the effects of Relacorilant on glucose control and its safety profile. Although the safety of this drug has been tested in prior human research studies, some side effects may not yet be known.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Age between 18 and 75 years.
2. Males or females
3. HbA1c between 7.5% and 10.5%
4. Type 2 diabetes with at least one of the following:

* Taking ≥ 3 glucose-lowering drugs
* Taking 2 glucose lowering medication and 2 anti-hypertensive drugs.
* Taking insulin and any other glucose lowering drugs
* Taking ≥ 2 glucose-lowering drugs and presence of microvascular (retinopathy, nephropathy, neuropathy) or ≥ macrovascular (heart attack, heart failure, peripheral vascular disease, atrial fibrillation) disease
5. No changes in diabetes medications in the 4 weeks prior to enrollment.
6. Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m².
7. Blood pressure lower than 170/110 mmHg.
8. Abnormal dexamethasone suppression test: morning plasma cortisol \>1.8 µg/dL with plasma dexamethasone ≥140 ng/dL.
9. Self-reported stable (within ±6 lbs in the last 3 months) body weight and body mass index (BMI) between 25-40 kg/m².
10. Negative Glutamic Acid Decarboxylase (GAD) antibody.
11. Hematocrit ≥ 34%.
12. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3× the upper limit of normal.
13. Female participants of childbearing potential must have a negative pregnancy test and agree to use appropriate contraception throughout the study. (Women who are using hormonal contraceptives will need to agree to use an acceptable method of non-hormonal contraception throughout the study and for ≥6 half-lives after the last dose of assigned treatment (7 days prior to randomization).

Exclusion Criteria:

1. Diagnosis of type 1 diabetes
2. New-onset diabetes of less than 1 year duration.
3. Presence of severe acute medical, psychiatric, or surgical illness.
4. Use of systemic (oral, IV, intra-articular, or inhaled) or topical glucocorticoids within the past 3 months.
5. Use of systemic glucocorticoid during the study is prohibited except in the event of medical emergency OR Requires inhaled glucocorticoid use and may require systemic glucocorticoids if their condition deteriorates during the study
6. Night shift workers (unless able to temporarily change sleep schedule to complete dexamethasone test).
7. Severe untreated sleep apnea. (Severe untreated sleep apnea, defined as an Apnea-Hypopnea Index (AHI) ≥ 30 events per hour on polysomnography, or a documented clinical diagnosis of severe sleep apnea in patients who are not receiving effective therapy (e.g., CPAP, BiPAP, oral appliance, or surgical treatment).
8. Excessive alcohol intake: \>14 drinks/week for men or \>7 drinks/week for women.
9. Diagnosed with or having treatment plans for Cushing syndrome
10. Known hypersensitivity to dexamethasone or relacorilant.
11. Severe, uncontrolled hypertension (\>170/110 mmHg) at screening.
12. Use of another investigational drug within 4 weeks or less than 5 half-lives of the compound, whichever is longer.
13. Pregnant or lactating women or women of childbearing potential (including all women \<50 years old, women whose surgical sterilization was performed \<6 months ag; and women who have had a menstrual period in the last 12 months; and women who have a positive pregnancy test before dexamethasone administration.)
14. Women with a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma.
15. Diagnosed with or having treatment plans for Cushing syndrome using any of the following treatments: mifepristone, metyrapone, osilodrostat, ketoconazole, fluconazole, aminoglutethimide, etomidate, octreotide, larazotide, pasireotide, long-acting octreotide or pasireotide.
16. Uncontrolled thyroid disease (hypo- or hyperthyroidism) prior to first dose of relacorilant as confirmed by TSH outside of normal range (0.4 to 5.0 mIU/L).
17. Has plans for adrenalectomy or adrenal nodulectomy during the study period.
18. Taking any co-medications that is disallowed with strong CYP3A inhibitors and cannot undergo dose modifications on coadministration with a strong CYP3A inhibitor
19. Ongoing use of any strong CYP3A4 inducer

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

Study team and timeline

Lead sponsor

The University of Texas Health Science Center at San Antonio

Study start

Dec 1, 2026 Estimated

Primary completion

Dec 15, 2028 Estimated

Study completion

Dec 15, 2029 Estimated

First posted

Nov 9, 2026 Actual

Last updated

Nov 9, 2026 Actual

Official study contacts