for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion
Principal Investigator
by Qin Yang, MD



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.


The objectives of this study are: to estimate SPI-62's effect on clinical features of hypercortisolism related to a benign adrenal tumor including diabetes/impaired glucose tolerance, hyperlipidemia, hypertension, and osteopenia; to evaluate the safety of SPI-62 in patients with hypercortisolism related to a benign adrenal tumor, including changes on hypothalamic pituitary adrenal (HPA) and hypothalamic pituitary gonadal (HPG) axes biomarkers and associated AEs; and to assess the pharmacological effect of SPI-62 on hepatocellular cortisol/cortisone equilibrium in patients with hypercortisolism related to a benign adrenal tumor. The study is a multicenter, randomized, double-blind, placebo-controlled study. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a 31-day screening period, a 12-week treatment period, and a 30-day follow-up period. Each subject will be randomized to receive 1 of 4 dose levels of SPI-62 or matching placebo for 12 weeks.


Autonomous Cortisol Secretion (ACS), ACTH-Independent Cushing Syndrome, ACTH-Independent Adrenal Cushing Syndrome, Somatic, ACTH-independent adrenal Cushing's syndrome (aCs), benign adrenal tumor, Adrenal Gland Neoplasms, Cushing Syndrome, Adrenocortical Hyperfunction, Syndrome, SPI-62 dose1, SPI-62 dose 2, SPI-62 dose 3, SPI-62 dose 4


You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

  • 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.


  • UC Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • University of California Los Angeles (UCLA) - Peter Morton Medical Building not yet accepting patients
    Los Angeles California 90095 United States

Lead Scientist at UC Irvine

  • Qin Yang, MD
    Associate Professor, Medicine, School of Medicine


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Sparrow Pharmaceuticals
Phase 2 research study
Study Type
Expecting 150 study participants
Last Updated