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New pill targets hormone imbalance from adrenal tumors

NCT ID NCT05436639

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Started

Jul 2023

Finished

Feb 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • C.M.D.T.A. Neomed

    Brasov, 500283, Romania

  • Institutul National de Endocrinologie

    Bucharest, 11863, Romania

  • King's College Hospital

    London, SW9 8RR, United Kingdom

  • Mayo Clinic Cancer Center (MCCC) - Rochester

    Rochester, Minnesota, 55905, United States

  • Ohio State McCampbell Outpatient Care

    Columbus, Ohio, 43210, United States

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