New pill targets hormone imbalance from adrenal tumors
NCT ID NCT05436639
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a daily pill called SPI-62 in 30 adults with high cortisol levels caused by a non-cancerous adrenal tumor. The goal was to see if the drug could safely lower blood sugar and improve other health measures. Participants took 2 mg of SPI-62 each day for up to 12 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Feb 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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C.M.D.T.A. Neomed
Brasov, 500283, Romania
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Institutul National de Endocrinologie
Bucharest, 11863, Romania
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King's College Hospital
London, SW9 8RR, United Kingdom
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Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, 55905, United States
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Ohio State McCampbell Outpatient Care
Columbus, Ohio, 43210, United States
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