NCT07104812招募中2 期
Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Adrenal insufficiency
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of 1 mg osilodrostat therapy in patients with mild autonomous cortisol secretion (MACS), and to determine the impact on 24h urine steroid metabolome and circadian cortisol/cortisone concentrations
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
- •Provide written informed consent
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Age ≥ 18 years
- •Diagnosed with MACS
- •At least 2 abnormal post-dexamethasone cortisol results:
- •i. 1 mg post-dexamethasone cortisol >1.8 mcg/dL or ii. 8 mg post-dexamethasone cortisol >1 mcg/dL
- •Historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment.
- •Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia)
- •At least one of the following comorbidities:
- •Obesity (BMI>30 kg/m2)
- •Dysglycemia
- •Dyslipidemia
- •Hypertension
- •Osteopenia
- •Osteoporosis
- •Fragility fractures
- •Ability to take oral medication and be willing to adhere to the study intervention regimen
- •For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤ 5% per year during the treatment period and for 1 month after the last dose of study treatment.
排除标准
- •Planned alternative therapy for MACS during the study period
- •Current use of oral exogenous glucocorticoid therapy
- •Current use of opioid therapy >20 MME/day
- •Planned use of oral exogenous glucocorticoid therapy
- •Planned use of opioid therapy >20 MME/day
- •Use of injectable glucocorticoid within the last 6 weeks or anticipated glucocorticoid use during the study period.
- •Hypokalemia of hypomagnesemia at baseline visit
- •Prolonged QTc on baseline ECG
- •Concomitant therapy with medications likely to lead to drug-drug interactions (based on PI review).
- •Investigator's judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome
- •Uncontrolled intercurrent illness including, but not limited to:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnancy or lactation
- •Known allergic reactions to osilodrostat
- •Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone.
- •Treatment with another investigational drug or other intervention within lower than specific therapy washout period
研究组 & 干预措施
Mild autonomous cortisol secretion (MACS)
Experimental
Women and men diagnosed with MACS who are patients at Mayo Clinic.
干预措施: Osilodrostat 1 MG (Drug)
结局指标
主要结局
Adrenal insufficiency
时间窗: 4 weeks
Number of subjects to experience adrenal insufficiency, defined as combined measurements of cortisol \< 7 mcg/dL and ACTH\>60 pg/dL or single cortisol \< 5 mcg/dL
Adverse Events
时间窗: 4 weeks
Number of adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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