SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor (NCT05436639) | Clinical Trial Compass
CompletedPhase 2
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
United States, Romania, United Kingdom30 participantsStarted 2023-07-01
Plain-language summary
This is study with SPI-62 to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor. Each subject will receive 2mg of SPI-62 daily.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Diagnosis and main criteria for inclusion and exclusion:
The following are the main inclusion criteria:
* 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 mor…