Open Actively Recruiting

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


Brief Summary

This will be a randomized, double-blind study to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor.

Primary Purpose
Study Type
Phase II


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

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 morning serum cortisol > 138 nM (5.0 mcg/dL) after ONDST, the Investigator will assess for adrenal Cushing's syndrome.

Exclusion Criteria:

  • Diagnosis of ACTH-dependent Cushing's syndrome, pheochromocytoma, aldosteronoma, adrenocortical carcinoma, or congenital adrenal hyperplasia, or other malignancy associated hypercortisolism including history of adrenal carcinoma.
  • History of adrenalectomy or planned adrenalectomy within 4 months after randomization.
  • Exogenous hypercortisolism.
  • Uncontrolled, clinically significant hypo- or hyperthyroidism.
  • History of idiopathic thrombocytopenia.
  • Moderately impaired renal function (estimated glomerular filtration rate < 60 mL/min/1.73m2).
  • History of cancer (other than non-melanoma skin, thyroid, or early-stage prostate cancer) within 3 years.
  • Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
  • Pregnant or lactating.
  • Positive test for severe acute respiratory syndrome coronavirus 2 infection within 4 weeks, or hospitalization for Coronavirus disease 2019 within 6 months, prior to randomization.
  • Any other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
  • Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.

Join this Trial

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Study Stats
Protocol No.
Samhita Mallavarapu
  • UCLA Westwood
For Providers
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