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

Korábbi kezelés

• Night shift workers (unless able to temporarily change sleep schedule to complete dexamethasone test).
• 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).
• Use of another investigational drug within 4 weeks or less than 5 half-lives of the compound, whichever is longer.
• 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).
• Taking any co-medications that is disallowed with strong CYP3A inhibitors and cannot undergo dose modifications on coadministration with a strong CYP3A inhibitor

Más betegség

• Diagnosis of type 1 diabetes
• New-onset diabetes of less than 1 year duration.
• Presence of severe acute medical, psychiatric, or surgical illness.
• 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
• Diagnosed with or having treatment plans for Cushing syndrome
• Known hypersensitivity to dexamethasone or relacorilant.
• Severe, uncontrolled hypertension (>170/110 mmHg) at screening.
• Women with a history of unexplained vaginal bleeding, endometrial hyperplasia with atypia or endometrial carcinoma.
• 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.

Életkor

• 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.)

Egyéb

• Use of systemic (oral, IV, intra-articular, or inhaled) or topical glucocorticoids within the past 3 months.
• Excessive alcohol intake: >14 drinks/week for men or >7 drinks/week for women.
• Has plans for adrenalectomy or adrenal nodulectomy during the study period.
• Ongoing use of any strong CYP3A4 inducer

• Age between 18 and 75 years.
• Males or females
• HbA1c between 7.5% and 10.5%
• 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
• No changes in diabetes medications in the 4 weeks prior to enrollment.
• Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m².
• Blood pressure lower than 170/110 mmHg.
• Abnormal dexamethasone suppression test: morning plasma cortisol >1.8 µg/dL with plasma dexamethasone ≥140 ng/dL.
• Self-reported stable (within ±6 lbs in the last 3 months) body weight and body mass index (BMI) between 25-40 kg/m².
• Negative Glutamic Acid Decarboxylase (GAD) antibody.
• Hematocrit ≥ 34%.
• Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3× the upper limit of normal.
• 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).