NCT05436639已完成2 期
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
Sparrow Pharmaceuticals5 个研究点 分布在 3 个国家目标入组 30 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Change in HbA1c at Week 6
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
SPI-62 dose
Experimental
2mg dose level of SPI-62. Active drug by mouth.
干预措施: SPI-62 dose (Drug)
结局指标
主要结局
Change in HbA1c at Week 6
时间窗: Baseline to week 6
HbA1c change from baseline
Change in HbA1c at week 12
时间窗: Baseline to week 12
HbA1c change from baseline
次要结局
未报告次要终点
研究者
研究点 (5)
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