SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

Inclusion Criteria

• •Diagnosis and main criteria for inclusion and exclusion:
• •Adults able to provide informed consent.
• •Documented characteristically benign adrenal nodule, with diameter ≤ 4 cm, homogenous texture, and non-contrast computerized tomography ≤ 20 HU attenuation or proven to be non malignant.
• •Diagnosis of diabetes mellitus, pre-diabetes or impaired glucose tolerance, either untreated or on stable standard of care treatment, based on at least one of:
• •* HbA1c ≥ 5.7% but not \> 9.5%
• •* 2-hour glucose level ≥ 7.8 mmol (140 mg/dL) on a 75 g OGTT
• •At least one additional documented cortisol-related morbidities, either untreated or on stable standard of care treatment:
• •* hypercholesterolemia with total cholesterol \> 3.9 mM (150 mg/dL);
• •* hypertriglyceridemia with triglycerides \> 2.3 mM (200 mg/dL);
• •* osteopenia with bone densitometry Z-score \< -2.0 or T-score \< -1.0;
• •* history or evidence of minimally traumatic or osteoporotic fracture; or
• •* hypertension with resting supine blood pressure \> 130 but \< 180 mmHg systolic or \> 85 but \< 120 mmHg diastolic.
• •Poorly suppressible hypercortisolemia:
• •* Morning serum cortisol \> 50 nM (1.8 mcg/dL) after a 1 mg ONDST.
• •* Subjects with dexamethasone \< 3.3 nmol/L (130 ng/dL) will undergo a high-dose (8 mg) ONDST.
• •* Subjects who take estrogen-containing medicines will be evaluated based on free cortisol \> 2.2 nM (80 ng/dL).
• •* For subjects with morning serum cortisol \> 138 nM (5.0 mcg/dL) after ONDST, the Investigator will assess for adrenal Cushing's syndrome.