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

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

Fase 1 / Fase 2

Rango de edad

18 años - 75 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

34 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No aplica

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (2)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

2 centros

Equipo y fechas

Patrocinador principal

The University of Texas Health Science Center at San Antonio

Inicio del estudio

1 dic 2026 Estimado

Finalización primaria

15 dic 2028 Estimado

Finalización del estudio

15 dic 2029 Estimado

Primera publicación

9 nov 2026 Real

Última actualización

9 nov 2026 Real

Contactos oficiales del estudio