Cushing Syndrome

Researchers are evaluating the accuracy of two diagnostic methods, 68Ga-Pentixafor PET/CT 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 PET/CT 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 PET/CT first followed by AVS, and the other group undergoes AVS first followed by 68Ga-Pentixafor PET/CT. 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 enicepatide, a drug that acts on two receptors related to blood sugar and weight control, for its effects on weight management in people with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to assess both effectiveness and safety over a long period. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The study uses a double-blind design, so neither participants nor researchers know who receives the active drug or placebo. Treatment lasts for 72 weeks, allowing detailed assessment of changes over time. Throughout the study, participants will regularly have their body weight measured to track percentage change from baseline, along with many other health indicators including blood sugar levels, cholesterol, blood pressure, and quality of life surveys. Safety will also be closely monitored through assessments of adverse events and specific health questionnaires. The total participation period extends through 72 weeks of treatment and follow-up to observe long-term effects.

Researchers are evaluating the effects of enicepatide, a dual GLP-1/GIP receptor agonist, for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III trial aims to assess the safety and effectiveness of multiple doses of enicepatide compared with placebo, focusing on body weight changes and related health outcomes. The study is sponsored by Hoffmann-La Roche and targets participants with specific body mass index criteria and weight-related health conditions. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The treatment period lasts 72 weeks, during which the participants receive regular doses as per their assigned group. Throughout the study, participants will be monitored for changes in body weight, waist circumference, blood sugar levels, cholesterol, blood pressure, and quality of life measures. Assessments include physical exams, questionnaires, and imaging such as MRI to measure body composition. Safety is closely tracked through adverse event reporting and mental health assessments. The total participation duration extends through the 72-week treatment and evaluation period, with detailed follow-up on various health indicators.

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 Cushing's syndrome, including Cushing's disease and Ectopic ACTH Syndrome (EAS). This Phase 1b/2a 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 drug's 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.

Researchers are evaluating the effects of Lu AG13909 in adults with Cushing's disease (CD), a rare and serious condition where the body produces too much cortisol hormone. This Phase II trial aims to study how Lu AG13909 affects cortisol levels, its safety and tolerability, and how the drug is absorbed and processed by the body. The sponsor of this trial is H. Lundbeck A/S. The trial has three parts: Part A includes an intravenous (IV) titration period, a subcutaneous (SC) treatment period, and a safety follow-up. Part B involves an SC titration period, a maintenance period, and another safety follow-up. There is also an extension period for long-term efficacy and safety assessment after Part B, followed by a safety follow-up. Participants first receive Lu AG13909 through IV according to a set dosing schedule, then switch to SC dosing as planned. Participants will undergo regular monitoring including urine cortisol measurements to assess treatment response. Researchers will track safety through laboratory tests, ECGs, vital signs, and adverse events up to several years. Pharmacokinetic assessments will evaluate how the drug behaves in the body. The main outcome is the reduction of urinary free cortisol to normal levels by the end of the titration periods. The total study duration can extend up to around three years, including long-term follow-up for safety and effectiveness.

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 investigating tumors affecting the hypothalamic-pituitary unit in children and adults aged 2 to 70 years. The study aims to identify genetic factors involved in the development of these pituitary tumors and related disorders, as well as to develop new clinical studies for their recognition and treatment. It also explores the psychological effects of cortisol secretion in children with Cushing disease and seeks to understand inheritance patterns and associations with other family conditions. Participants undergo procedures including tissue specimen collection and MRI scans to study the molecular genetics of tumors and related developmental pathways. This observational protocol serves as a screening and training platform for medical fellows and students and supports the development of future clinical trials focused on diagnosis and therapy of pituitary tumors. During the study, participants provide peripheral blood and tumor tissue samples for molecular genetic testing. Researchers assess cognitive, psychological, and patient-reported health outcomes related to hypercortisolemia and adrenal insufficiency. The study also monitors clinical and genetic features of pituitary tumors and collects data on mental and social well-being. Participation involves ongoing assessments and follow-up to support future research and clinical care improvements.

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.