Clinical Trials for Cushing's Syndrome

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Cushing’s Syndrome from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 25
• Active, not recruiting: 6
• Completed: 14
• Other: 5

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT00669266 — Adrenal Tumors - Pathogenesis and Therapy

The pathogenesis of adrenal tumors is still not fully elucidated and the treatment options for malignant tumors are poor. The current study investigates different aspects of the pathogenesis of adrenal tumors and evaluates different therapeutic options in patients with adrenocortical carcinoma.

NCT02019706 — Prospective Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Ectopic Cushing Syndrome

Between 10% and 15% of patients with endogenous hypercortisolism (Cushing syndrome) have ectopic (non-pituitary) production of adrenocorticotropin hormone (ACTH) that causes cortisol excess. In approximately 50% of these patients, the tumoral source of ACTH cannot be found initially despite very detailed and extensive imaging, including studies such as computed tomography, magnetic resonance im…

NCT02830308 — Evaluation of Adults With Endocrine and Metabolic-Related Conditions

Background:

There are many endocrine and metabolic-related conditions. Two well-known disorders include diabetes and thyroid disease. Some of these diseases are caused by a change in genes. Researchers want to identify the genes involved in these disorders. They hope this will help them learn more about these diseases.

Objectives:

To learn more about conditions that affect the hormone-secret…

NCT03364803 — Collecting Information About Treatment Results for Patients With Cushing’s Syndrome

The purpose of this study is to follow participants with Cushing’s syndrome during the course of their routine care and to form a data registry to study long term participant outcomes.

NCT04127552 — Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations

The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can improve metabolic parameters and cardiovascular risks and features.

NCT04543253 — Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion (MACS)

Cushing syndrome (CS) is an endocrine disorder caused by chronic exposure to glucocorticoid (GC) excess. Endogenous CS has an estimated incidence of 0.2 to 5.0 cases per million per year and prevalence of 39 to 79 cases per million in various populations. CS usually affects young women, with a median age at diagnosis of 41.4 with a female-to-male ratio of 3:1. Following a curative surgery for C…

NCT03708900 — Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing’s Syndrome

Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing’s syndrome.

NCT05759637 — Type 2 Diabetes, Obesity and Cortisol Excess

The present observational cross-sectional study is aimed to assess: the hidden hypercortisolism (HidHyCo) prevalence in a sample of Type 2 diabetes (T2D) patients and the clinical characteristics more frequently associated with the HidHyCo presence and the HidHyCo prevalence in an adequate sample of obese patients without T2D and the clinical characteristics more frequently associated with the …

NCT05368090 — Endoscopic Ultrasound-guided Radiofrequency Ablation in Primary Aldosteronism

In this study, the investigators will perform endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) treatment of left-sided adrenal tumours in patients with primary aldosteronism (PA) and in patients with mild autonomous cortisol secretion (MACS). Four different study groups will all receive EUS-RFA of left-sided adrenal tumours. Clinical and biochemical outcome as well as procedural s…

NCT06962202 — Modified Desmopressin (mDesmo) Using Cold-Kit for PET/CT

The incidence of Cushing syndrome (CS) is 1.2-3.2 cases per million per year, of which adrenocorticotropic Hormone (ACTH)-dependent disease comprises approximately 70-80% of cases. Among these, nearly 90% of ACTH-dependent CS are due to pituitary-dependent CS, known as Cushing disease (CD). The management of ACTH-dependent CS relies on distinguishing Cushing disease (or Corticotropinoma) from e…

NCT05521529 — Cushing’s Syndrome Before and After Treatment (CORRECT)

The purpose of this study is to prospectively study patients with Cushing’s syndrome before and after treatment, with a special emphasis on physical function, quality of life, and circadian rhythms.

The hypotheses are:

• Cushing’s syndrome negatively impacts health-related quality of life (HRQoL) and physical functioning
• Cushing’s syndrome is associated with altered circadian rhythms at the…

NCT06341699 — Study of the Steroid Hormone Milieu in Obese Patients

The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of o…

NCT07350707 — Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing’s Syndrome

In previous clinical practice, 68Ga-Pentixafor PET/CT has demonstrated promising diagnostic utility in various neuroendocrine tumors by targeting CXCR4, a chemokine receptor overexpressed in several ACTH-secreting neoplasms. Building on this, and leveraging the Nuclear Medicine expertise at Peking Union Medical College Hospital, we aim to conduct a prospective observational study investigating …

NCT05804669 — A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing’s Syndrome

A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone [ACTH] receptor antagonist) in participants with ACTH-dependent Cushing’s syndrome (Cushing’s disease or Ectopic ACTH Syndrome [EAS])

NCT06573723 — Institutional Registry of Rare Diseases

The goal of this observational study is to create a single macro registry system with data collection on common clinical features, grouping the different rare diseases (RD).

Moreover, the specific goals are to generate an alert system for possible cases of RD with data from the electronic medical record, to describe the occurrence of RD in the evaluated population, to characterize the populati…

NCT06430528 — A Block-and-Replace Therapy With Osilodrostat and Concomitant Glucocorticoid Replacement

The major goal of this study is to determine the incidence of adrenal insufficiency in patients with endogenous Cushing syndrome receiving osilodrostat treatment combined with a replacement of glucocorticoid (block-and-replace approach).

The investigators are also evaluating new biomarker steroids to reflect adequate osilodrostat dosing, the durability and safety, and clinical improvement duri…

NCT06246357 — Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism

Background:

The adrenal glands are 2 small organs that sit on top of each kidney. They release hormones; these are chemicals that control how the body works. Tumors on or outside the adrenal glands are called functional if they release hormones; they are called nonfunctional if they do not. Doctors who treat adrenal tumors need to know which type a person has. Researchers want to find better w…

NCT06635629 — Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome

Background:

Cushing syndrome (CS) is a set of diseases that develop when the body produces too much adrenocorticotropic hormone (ACTH). ACTH stimulates the production of a hormone called cortisol. Excess cortisol can cause serious issues, such as diabetes, high blood pressure, weight gain, and mood changes. Diagnosing CS early can be difficult. One test used to diagnose CS, the desmopressin (D…

NCT07168122 — Establishment and Clinical Application of Reference Intervals of Salivary Cortisol

The goal of this observational study is to establish the normal reference intervals of salivary cortisol and optimal cut-offs for Cushing’s sydrome and adrenal insufficiency.

NCT07156370 — Salivary Cortisol and Hypercortisolism in Type 2 Diabetes

The goal of this observational study is to explore the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes despite receiving standard-of-care therapies. Additionally, the study will evaluate the correlation between salivary cortisol levels and glycemic control.

NCT07296484 — Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).

NCT07412782 — REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)

This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free ultrasound technology. Bone health is crucial during childhood, when peak bone mass develops, and reduced BMD is associated with increased fracture risk. DXA is the cu…

NCT07104812 — Impact of 1 mg Osilodrostat Therapy on Mild Autonomous Cortisol Secretion (MACS)

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

NCT07247058 — Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)

To characterize the impact of Isturisa on clinical features and comorbidities associated with MACS. The investigators hypothesize that patients treated with Isturisa will exhibit significantly better metabolic indicators (such as fasting glucose, HbA1c, and lipid profile), blood pressure, weight, body composition and bone mineral density than at Baseline. The investigators also assess the effec…

NCT07361874 — IMPACT-MACS: Adrenalectomy vs Semaglutide for Metabolic Outcomes in Mild Autonomous Cortisol Secretion

The goal of this study is to learn how two treatments-adrenalectomy (surgical removal of an adrenal gland) and semaglutide (a medication used for weight management)-affect insulin resistance and cortisol regulation in adults with mild autonomous cortisol secretion (MACS). The study will also learn how these treatments impact body composition, blood pressure, cholesterol, inflammation, muscle st…

Active, Not Recruiting

NCT00457587 — Preclinical Study Towards an Immunotherapy in Adrenocortical Carcinoma

Adrenocortical carcinoma (ACC) is a rare and heterogeneous malignancy with poor prognosis. Surgical resection of the tumor is the treatment of choice. However, even after complete resection more than 80 % of patients will experience recurrence of disease. Therefore, new treatment options are urgently needed. This pre-clinical study try to lay the foundations for a successful immunotherapy in pa…

NCT03211624 — Quality of Life, Fatigue and Cognitive, Affective and Emotional Dysfunction in Patients With Cushing’s Syndrome

This is a prospective, multi-center, case-control study where neurocognitive function will be evaluated in 36 patients with Cushing syndrome (CS) and 36 controls matched for age, gender and education.

NCT03604198 — Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

NCT05382156 — Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing’s Syndrome

This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing’s Syndrome

NCT04840693 — Genomic and Metabolomic Markers Reflecting the Complications of Hypercortisolism (CUSHINGOMICS)

The excess of glucocorticoid, whether endogenous or exogenous, results in Cushing’s syndrome, associating a particular distribution of fats (accumulation in the face and trunk), a decrease in the thickness of the muscles, diabetes, hypertension or osteoporosis.

The level of effects obviously depends on the extent of the excess glucocorticoids, and on the duration of this exposure. However, the…

NCT06106295 — Metyrapone for Mild Autonomous Cortisol Secretion (MACS)

The purpose of this study is to find out whether the study drug, metyrapone, is safe and effective in treating participants with Mild Autonomous Cortisol Secretion (MACS).

Not Yet Recruiting

NCT06980753 — Continuous Steroid Monitoring in Interstitial Fluid With Wearable and Nanoparticle-enhanced Biosensors for Improved Management of Adrenal Disorders

The goal of this project is to provide novel technology that will pave the way from the present single-point (analogue) endocrinology towards continuous cortisol and aldosterone monitoring with full time resolution. Current endocrine practice relies on occasional and often random determination of hormone level or functional tests that require a clinical setting. These measurements include sampl…

NCT07138274 — Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS

single-center, randomized, double-blind, placebo-controlled Phase 2 study to evaluate safety and efficacy of overnight metyrapone in patients with MACS.

NCT07247162 — Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing’s Syndrome

Osilodrostat has proven to be a safe and efficacious treatment for patients with CS. Demonstrating normalisation of hypercortisolaemia and in patients with hypertension and/or dysglycaemia clinically relevant and statistically significant reductions in blood pressure and glycaemia. This study aims at providing additional evidence on the safety, efficacy and appropriate dosing of osilodrostat in…

Enrolling by Invitation

NCT07603466 — Combination Osilodrostat and Cabergoline in Cushing’s Disease

Cushing disease remains a challenging endocrine disorder in which persistent or recurrent hypercortisolism often requires medical therapy after surgery or when surgery is not feasible. Combination medical therapy has emerged as a rational strategy to improve biochemical control through complementary mechanisms while potentially reducing treatment escape and dose-related toxicity. Cabergoline ex…

Completed Trials

NCT00001452 — Defining the Genetic Basis for the Development of Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the Carney Complex

Lentiginosis refers to groups of diseases marked by the presence of pigmented spots on the skin. These conditions are most commonly associated with multiple tumors and changes in hormone producing glands. The cause of these diseases is unknown, but researchers suggest there may be a level of inheritance involved in their development. Meaning to say that some of these diseases may “run in the fa…

NCT00005927 — Study of Adrenal Gland Tumors

The adrenal glands, located atop the kidneys, normally produce several types of hormones. Tumors of these glands may or may not secrete hormones. It is not known what causes these tumors or why some secrete hormones and others do not. Some of the tumors are benign and confined to the adrenal gland, and others are malignant (cancerous), and can spread to other parts of the body. This study will …

NCT02889224 — In Vivo Study of Interactions Between the Endocannabinoid System and the Corticotropic Axis in Man

Working hypothesis: the interactions between the endogenous endocannabinoïds (ECS) - and cortisol, the end product of the Hypothalamo-Pituitary-Adrenal (HPA) axis may play a role in the pathophysiology of Cushing’s syndrome.

The investigators speculate that:

• acute or chronic variations in plasma cortisol may induce changes in the activity of the ECS
• that there is a circadian rhythm of the…

NCT02603653 — Assessment of Persistent Cognitive Impairment After Cure of Cushing’s Disease

Cushing’s disease is a state of chronic endogenous glucocorticoid excess. Cushing’s disease is responsible for increased morbidity and mortality. Recent studies have pinpointed the frequency of somatic sequelas and persistent alteration in quality of life despite the cure of the disease. More specifically, a few studies have described persistent psychopathology, maladaptive personality and cogn…

NCT07350031 — Serum and Salivary Cortisol Assessment in Patients With Adrenal Incidentalomas and Healthy Controls

The goal of this observational study is to evaluate the diagnostic accuracy of salivary cortisol compared with serum cortisol after a 1 mg overnight dexamethasone suppression test in participants (N = 100) with adrenal incidentalomas and healthy control participants (N = 100). The main question it aims to answer is:

Are salivary cortisol and serum cortisol equal diagnostic tools for endogenous…

NCT03162068 — Cushing’s Osteoporosis Specificities

Osteoporosis induced by glucocorticoids excess constitutes the main cause of secondary osteoporosis. Most of data available are provided from cohort studies of patients treated by corticosteroids, affecting among 1% of population. In contrast, very few data on osteoporosis are available in the Cushing syndrome (CS), a rare disease affecting 1 or 2 million of inhabitants, and characterized by an…

NCT07282223 — Contralateral Adrenal Volume Predicts Duration of Postoperative Steroid Replacement Therapy in Non-ACTH-dependent Hypercortisolism

To identify preoperative factors influencing the duration of steroid replacement therapy after adrenalectomy/adrenal-sparing surgery in patients with non-ACTH-dependent hypercortisolism.

NCT03697109 — A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome

This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance (DM/IGT) and/or uncontrolled hypertension (HTN).

NCT03621280 — Open-label Treatment in Cushing’s Syndrome

This is a long-term, open-label extension study of levoketoconazole in participants with endogenous Cushing’s Syndrome.

NCT04308590 — A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas

This is a Phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy, and safety of relacorilant to treat hypercortisolism in patients with cortisol-secreting adrenal adenoma or hyperplasia associated with diabetes mellitus/ impaired glucose tolerance (DM/IGT) and/or uncontrolled systolic hypertension (HTN).

NCT05255900 — Effects of Metyrapone in Patients With Hypercortisolism

The aims of the present study are to evaluate in patients with mild hypercortisolism the effect of metyrapone treatment on glycometabolic control, blood pressure, thrombotic risk parameters, lipid profile, bone turnover markers, mental health and cortisol circadian rhythm.

NCT05307328 — SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing’s Syndrome

This is a randomized, placebo-controlled, study of SPI-62 in subjects with ACTH-dependent Cushing’s syndrome caused by a non-adrenal tumor. Subjects will receive each of the following 2 treatments for 24 weeks: SPI-62 and matching placebo with the option of long-term extension.

NCT05436639 — SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

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.

NCT06829537 — Study of the Prevalence of Endogenous Hypercortisolism in Patients With Resistant Hypertension (MOMENTUM)

This is a non-interventional study to assess the prevalence of endogenous hypercortisolism (eHC) in patients with resistant hypertension (rHTN) and will enroll approximately 1000 patients at approximately 45 sites in the United States (US).

Each patient will have an initial visit for screening. After eligibility is confirmed, a limited exam will be performed and demographic and medical history…

Other (Terminated)

NCT05038878 — An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women

The purpose of this research study is to determine if treatment with Elagolix will improve body weight, waist circumference, muscle strength, cortisol secretion, blood glucose, cholesterol, and bone quality as well as mood and quality of life in a female patient with mild hypercortisolism from adrenal overproduction of cortisol. Many people with adrenal nodules, or non-cancerous growths in the …