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SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT05436639•Sparrow Pharmaceuticals

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.

Detailed Description

This is a multicenter, open-label, single-arm study, Phase 2 study 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. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in a screening period and an open-ended treatment period. Visits occur at screening/baseline, months 1, 3, 6, 9, and 12, and then quarter-annually.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis and main criteria for inclusion and exclusion:
•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;
+7 more criteria

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.
+2 more criteria

Locations (5)

Mayo Clinic Cancer Center (MCCC) - Rochester

Rochester, Minnesota, United States

Ohio State McCampbell Outpatient Care

Columbus, Ohio, United States

C.M.D.T.A. Neomed

Brasov, Romania

Institutul National de Endocrinologie

Bucharest, Romania

King's College Hospital

London, United Kingdom

Key Dates

Start Date

July 1, 2023

Primary Completion Date

December 1, 2024

Completion Date

February 18, 2025

Last Updated

February 13, 2026

Enrollment

ACTUAL participants

Conditions

Autonomous Cortisol Secretion (ACS)ACTH-Independent Cushing SyndromeACTH-Independent Adrenal Cushing Syndrome, Somatic

Interventions

SPI-62 dose

DRUG