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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.