Cushing Syndrome

Researchers are evaluating the accuracy of two diagnostic methods, 68Ga-Pentixafor PETCT and adrenal venous sampling AVS, in identifying the subtype of primary aldosteronism PA concurrent with autonomous cortisol secretion ACS in patients with adrenal nodules. This prospective, multicenter, randomized crossover trial aims to compare the diagnostic performance of these methods based on biochemical and clinical remission outcomes, focusing on whether 68Ga-Pentixafor PETCT is not less accurate than AVS. The main goal is to guide treatment decisions effectively based on these diagnostic results. Participants are randomly assigned to one of two groups one group undergoes 68Ga-Pentixafor PETCT first followed by AVS, and the other group undergoes AVS first followed by 68Ga-Pentixafor PETCT. Treatment strategies are then guided by the diagnostic findings. Both interventions are diagnostic tests used to determine unilateral primary aldosteronism, with specific criteria for diagnosis based on imaging and sampling results. This crossover design allows each patient to receive both diagnostic methods in different orders. During the study, participants will be monitored with a primary focus on the proportion of complete biochemical remission at 6 months postoperatively. Additional assessments include clinical remission rates and diagnostic accuracy in the surgical population. The study includes follow-up visits at 6 months after treatment to evaluate outcomes. Safety and treatment effectiveness are monitored throughout the trial, which is expected to last until the end of 2029.

Researchers are studying patients with endogenous Cushing syndrome to understand how often adrenal insufficiency occurs when treated with osilodrostat combined with glucocorticoid replacement. The study also examines new steroid biomarkers to monitor osilodrostat dosing, and assesses treatment durability, safety, and clinical improvement. This observational study aims to provide important insights into managing this condition with a block-and-replace approach. The study has two phases. In Phase 1 Titration, participants start with a low dose of osilodrostat and add methylprednisolone replacement. Doses are adjusted to reach specific cortisol level goals, with frequent monitoring and communication. Once these goals are met, participants enter Phase 2 Maintenance, where they continue treatment for 48 weeks with periodic cortisol tests to track treatment effects. Participants will regularly provide blood and saliva samples for cortisol and steroid profiling, and report symptoms related to adrenal insufficiency. Researchers will track clinical measures such as blood pressure, weight, and quality of life over about 48 weeks. The main outcome is the percentage of participants experiencing adrenal insufficiency during Phase 1, along with various secondary health and hormone measures throughout the study.

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III, randomized, double-blind study aims to assess both the efficacy and safety of once-weekly enicepatide in this population, addressing weight-related comorbidities such as prediabetes, hypertension, and cardiovascular conditions. Participants will be randomly assigned to receive either placebo or one of three enicepatide dosing regimens, administered once weekly via an integrated drug-device combination product. The treatment phase lasts through 72 weeks, during which changes in body weight and other health measures are monitored. The study includes multiple assessments to track body weight percentage change, waist circumference, fasting glucose and insulin levels, lipid profiles, blood pressure, and quality of life measures. Throughout the study, participants will undergo regular evaluations including physical examinations, laboratory tests, and questionnaires related to physical functioning and urinary incontinence. Researchers will monitor adverse events, patient-reported health questionnaires, and biomarkers at baseline and weekly intervals through week 72. This long-term follow-up allows for a comprehensive assessment of treatment effects and safety in participants managing obesity or overweight without Type 2 diabetes.

This clinical trial investigates the safety and recovery benefits of tubeless laparoscopic adrenalectomy in patients undergoing adrenal gland removal surgery. The study aims to answer whether avoiding drainage tubes after surgery helps patients recover more quickly, focusing on pain, the time to first get out of bed, and the recovery of intestinal function. It is a prospective, single-center, randomized controlled study enrolling 200 patients who need laparoscopic adrenalectomy. Participants are randomly assigned to one of two groups one group receives surgery without drainage tubes tubeless group, and the other group has drainage tubes placed after surgery drainage group. The study compares outcomes such as pain scores, blood tests, and recovery indicators between these groups. Follow-up includes adrenal ultrasounds at one and six months post-surgery to monitor recovery and safety. During the study, participants will have blood tests and assessments of pain, time to mobilization, and intestinal function for the first three days after surgery. Researchers will also monitor for complications like fever and wound infections. Follow-up ultrasound exams at one and six months will help evaluate longer-term recovery. The trial uses block randomization and collects data to assess whether tubeless surgery promotes faster and safer recovery after adrenalectomy.

Researchers are evaluating CRN04894, an adrenocorticotropic hormone ACTH receptor antagonist, in adults with ACTH-dependent Cushings syndrome, including Cushings disease and Ectopic ACTH Syndrome EAS. This Phase 1b2a open-label study aims to explore the safety, tolerability, pharmacokinetics PK, and pharmacodynamic biomarker responses of CRN04894 in this patient population. The study is a first-in-disease, multiple-ascending dose exploratory trial to better understand how the drug behaves and affects the condition. Participants will receive oral doses of atumelnant CRN04894 once daily for either 10 or 14 days in a sequential, open-label format. The treatment periods are followed by a 4-day washout phase after the 10-day dosing group. The study includes fixed-dose cohorts and monitors participants throughout these periods to assess the drugs impact on the disease and the body. During the study, participants will undergo monitoring for safety, including treatment-emergent adverse events, adrenal insufficiency, and laboratory test findings, all assessed up to Day 15. Pharmacokinetic measures include maximum plasma concentration, time to reach this concentration, and plasma exposure over time. Additionally, early morning serum cortisol levels will be tracked to evaluate changes from baseline. The total participation involves dosing and follow-up assessments to collect this comprehensive data.

This trial investigates the effects of Lu AG13909 in adults with Cushings disease, a rare condition caused by excess cortisol production. The study aims to evaluate how Lu AG13909 affects cortisol levels, as well as its safety, tolerability, and how the body processes the drug. This is a Phase II, open-label trial sponsored by H. Lundbeck AS. The trial is divided into three parts Part A includes intravenous IV titration, subcutaneous SC dosing, and a safety follow-up Part B involves SC titration, maintenance dosing, and another safety follow-up and an Extension Period focuses on long-term efficacy, safety, and continued monitoring. Participants receive Lu AG13909 first by IV and then by SC according to predefined dosing schedules. Participants will undergo regular assessments including urine and blood tests to measure cortisol and drug levels, safety evaluations, and monitoring for adverse effects. The main outcome is the reduction of urinary free cortisol to normal levels. The trial lasts up to about 490 days for initial periods, with extended follow-up up to 1037 days to assess long-term effects and safety.

Researchers are investigating the causes and development of adrenal tumors, which include adrenocortical carcinoma, Cushing syndrome, Conn syndrome, and pheochromocytoma. The study aims to better understand how these tumors form and to evaluate new treatment options for patients with malignant adrenal tumors, addressing the limited current therapies available. This observational research is sponsored by the University of Wuerzburg and has been ongoing since 2002. Participants in the study may provide tumor material and related biological samples if they have adrenal tumors. Additionally, biological samples are collected from patients without adrenal tumors to serve as comparison controls. The research does not involve experimental treatments but focuses on collecting and analyzing biospecimens to explore tumor biology and potential therapies. Throughout the study, participants contribute by providing tumor and biosample materials. Researchers analyze these samples to study tumor characteristics and evaluate possible new treatments. There are no specific outcome measures listed. The study is observational, with no assigned treatments, and aims to gather information to support future therapeutic developments. Participants involvement duration varies, and the study is expected to continue until December 2032.

Researchers are studying tumors of the hypothalamic-pituitary unit in children and adults aged 2 to 70 years, aiming to understand the genetic causes and developmental pathways involved in pituitary gland tumors. This observational study also serves as a training protocol for fellows and students to learn about genetic defects, tumor recognition, management, and complications. The study includes research on new MRI tools and psychological effects of cortisol secretion in pediatric patients with Cushing disease. Participants with tumors or related hypothalamic-pituitary disorders undergo various procedures including MRI scans and tissue specimen collection. The study collects peripheral blood samples and tumor tissues for molecular genetic testing and whole exome sequencing. It also evaluates cognitive, psychological, and patient-reported outcomes related to hypercortisolemia and adrenal insufficiency in children with Cushing syndrome. Participants are assessed through imaging studies, biochemical tests, and genetic analysis. The study monitors psychological and cognitive health and collects patient-reported data on mental and social well-being. This protocol also functions as a screening platform for future clinical studies on diagnosis, treatment, and follow-up of pituitary tumors. Participation involves ongoing evaluation with no specified end date, supporting the development of new therapeutic approaches and research in pituitary tumor biology.

Researchers are studying how artificial intelligence AI can be used to detect adrenal nodules by analyzing chest low-dose spiral CT scan images. The goal is to develop AI software with independent intellectual property that can screen for adrenal nodules specifically in chest CT scans. This research focuses on improving the identification of adrenal glands and nodules using advanced imaging analysis techniques. The study uses existing chest low-dose CT images collected from routine physical examinations. It involves AI-based segmentation of the adrenal region and identification of adrenal nodules from these images. No treatments or interventions are given to participants since this is an observational study based on image data. Participants provide chest CT images that are analyzed with AI algorithms to test their accuracy in recognizing adrenal nodules. Researchers will measure the overall diagnostic accuracy of the AI from enrollment through one and a half years of data collection. The study includes adults 18 years and older and excludes images with poor quality or patients with a history of malignant tumors. Participation involves image review only, with no additional procedures or treatments.