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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    150
  • sponsor
    Sparrow Pharmaceuticals
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Updated on 13 October 2022
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Summary

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.

Description

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.

Details
Condition Autonomous Cortisol Secretion (ACS), ACTH-Independent Cushing Syndrome, ACTH-Independent Adrenal Cushing Syndrome, Somatic
Treatment Placebo, SPI-62 dose1, SPI-62 dose 2, SPI-62 dose 3, SPI-62 dose 4
Clinical Study IdentifierNCT05436639
SponsorSparrow Pharmaceuticals
Last Modified on13 October 2022

Eligibility

 Yes No Not Sure

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%
-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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