Clinical Research Directory

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.

The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it. The study consists of a part A double-blinded treatment period, a part B treatment/observation period and a part C open-label treatment/observation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment. The total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment. More information can be found here: https://clinicaltrials.argenx.com/vitalithy

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease

The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it. The study consists of a part A double-blinded treatment period, a part B treatment/observation period and a part C open-label treatment/observation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment. The total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment. More information can be found here: https://clinicaltrials.argenx.com/vitalithy

NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease

The purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease

The goal of this randomized pilot feasibility clinical trial is to determine the feasibility of implementing a protocol for a larger trial to assess the effects of high-dose vitamin D supplementation in pediatric patients (9-17 years old) newly diagnosed with Graves' disease. The main questions it aims to answer are: What are the recruitment and adherence rates for a larger trial using this protocol? Is the data collection process complete and robust enough for a larger trial? What are the potential barriers to implementing a larger-scale trial? Researchers will compare vitamin D supplementation plus standard methimazole therapy to methimazole therapy alone (with participants permitted to take up to 1000 International Units of vitamin D2 daily) to explore potential effects on thyroid hormone and antibody levels. Participants will: Be randomized to either the intervention or control group. Take study medications (vitamin D or placebo) as directed. Attend regular study visits for blood tests and clinical assessments. Complete medication logs.

Personalized Treatment in Thyroid Disorders

The Collar Therapy Indicator (CoTI) (A device that is placed in collar around the neck resembling a turtle neck sweater collar with a wire and recording box) has been shown in a single small previously published experience to provide data regarding radioiodine exposure that correlates with conventional methods of measuring I-123 and I-131 uptakes after diagnostic dose administration and/or therapy for thyroid disorders. We hypothesize that the device's continuous measurement capability will permit more accurate estimates of radiation exposure to thyroid tissue than conventionally employed methods assessing fractional uptake at one or a few time points. It may also provide information about the extent of variability in the absorbed radiation dose among patients with thyroid cancer and hyperthyroidism. By providing more complete information about individual patient's exposures, it will facilitate more accurate estimation of the administered I-131 dose requirements for control of hyperthyroidism and thyroid remnant ablation while reducing the need for repeated visits to the clinic for dosimetry measurements. The aims of our project include the following: (1)To compare quantitative imaging-derived thyroid time activity curve to that obtained using the CoTI and to determine the extent to which there is variability in radiation dose predicted using conventional methods to that predicted from measurement of the full Time-Activity Curve (TAC).(2) Evaluate the uptake and clearance kinetics across the 5 patients in each category as proof of principle for a potential larger trial to investigate use of this device in optimizing the administered doses of radioactive iodine to achieve therapeutic goals while minimizing risks of comorbidities, such a post-radioiodine hypothyroidism in patients with Graves' disease.(3)Evaluate patient experience, convenience, and discomfort in using the CoTI device with a survey instrument.

Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)

Graves' disease is an autoimmune condition that causes an overactive thyroid. Some people with Graves' disease develop thyroid eye disease, also called Graves' orbitopathy, which can cause swelling around the eyes, eye discomfort, double vision, changes in appearance, and, in severe cases, problems with vision. The purpose of this study is to find out whether atorvastatin, a commonly used cholesterol-lowering medicine, can reduce the risk of developing active thyroid eye disease in adults who have recently been diagnosed with Graves' disease. A total of 554 participants will be randomly assigned to one of two groups. One group will receive atorvastatin 40 mg once daily for 12 months in addition to standard treatment for Graves' disease. The other group will receive standard treatment for Graves' disease alone. Participants will be followed for 18 months. During the study, participants will have regular assessments of their thyroid disease and their eyes. Blood samples and questionnaires about symptoms and quality of life will also be collected. The researchers will compare the two groups to determine whether atorvastatin reduces the development of active thyroid eye disease.

Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease

The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid

Impact of Restrictive Diets on Inflammation and Quality of Life in Autoimmune Thyroiditis

The purpose of this clinical trial is to evaluate whether a dietary intervention can improve clinical and immunological outcomes in women with autoimmune thyroid disease (AITD), including Hashimoto's thyroiditis and Graves' disease. The study will enroll premenopausal women aged 18 to 55 years. The dietary intervention consists of the simultaneous exclusion of three groups of potentially pro-inflammatory dietary components: * Gluten-containing cereals, including wheat, barley, and rye. * Casein, the main protein found in milk and dairy products. * High-glycemic-index carbohydrates, such as refined sugar, white bread, and white rice. The primary objective is to determine whether the dietary intervention reduces serum levels of anti-thyroid peroxidase (anti-TPO) antibodies, which are markers of thyroid autoimmunity. Secondary objectives include evaluating whether the intervention improves: * Fatigue and energy levels. * Mood and emotional well-being. * Gastrointestinal symptoms. * Health-related quality of life. Women following the dietary intervention will be compared with women who continue their habitual diet to assess the effectiveness of the intervention. Group allocation will be based on participants' choice at study enrollment. Participants will: * Follow either the dietary intervention or their usual diet for 12 months while continuing their prescribed medical treatment. * Attend four study visits: at baseline and after 4, 8, and 12 months. * Undergo anthropometric assessments (body weight and waist circumference), blood sampling, stool collection, and a telemedicine consultation with a thyroid specialist at each visit. * Complete brief online questionnaires every month to assess dietary adherence, fatigue, mood, gastrointestinal symptoms, and quality of life.

AI-Based Wearable Monitoring (Glandy HYPER) for Antithyroid Drug Dose Adjustment in Graves' Disease

Graves' disease is the most common cause of hyperthyroidism and is usually treated with antithyroid drugs such as methimazole (MMI). The MMI dose is adjusted according to periodic blood tests, but individual responses vary, so some patients remain hyperthyroid longer than necessary while others become hypothyroid from overtreatment. Glandy HYPER is a CE-marked, AI-based software medical device that analyzes sleep heart rate data collected by a smartwatch, together with thyroid function test results, to provide daily information on thyrotoxicosis status. This exploratory, post-market, two-center, randomized, open-label study in Germany evaluates whether MMI dose adjustment supported by Glandy HYPER shortens the time to normalization of free T4 compared with standard care, and also assesses overtreatment, thyroid-related quality of life, and safety.

Prospective Evaluation of OptiThyDose

The aim of this multicentric, randomised, two-arms and single-blinded clinical trial is to prospectively evaluate OptiThyDose for Congenital hypothyroidism (CH) and Graves' disease (GD).

Thyroid Disorders in Pediatric Autoimmune Hepatitis

This cross-sectional study aims to determine the frequency and spectrum of thyroid disorders among children with autoimmune hepatitis attending Assiut University Children's Hospital.

Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease

Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored hyperthyroidism in Graves' disease is an autoimmune complication. The aim of this study is to explore immunological markers possibly associated with mental fatigue in Graves' disease, which the investigators plan to validate in another study (ImmunoGraves wp 2). Using a cross-sectional study design, mental fatigue is scored using a questionnaire to find 60 patients with and 60 without mental fatigue 15-60 months after diagnosis of Graves disease. The patients and 60 thyroid healthy controls without mental fatigue are assessed for thyroid hormones, quality of life, anxiety and depression, self-evaluated stress, coping strategies, eye symptoms and background variables. SciLifeLab in Stockholm, the national facility for autoimmune profiling, has pre-set large arrays including 42000 human proteins. Serum and cerebrospinal fluid will be separately pooled and analysed for a subgroup of patients with or without mental fatigue and for a subgroup of the control group. Proteins that preferably bind to antibodies in sera and/or cerebrospinal fluid from Graves' patients with mental fatigue in comparison to non-mental fatigue patients, will be screened against the Human Protein Atlas and the Allen brain map to identify those proteins that are expressed in the brain. Antibodies at higher concentration in the mental fatigue pools compared to the group without mental fatigue will be selected for further analyses on an individual level in the whole cohort together with antibodies targeting g-protein coupled receptors, thyroid autoantibodies, cytokines and biomarkers indicating organic and structural nerve damage.

Validating Immunological Markers Associated With Mental Fatigue in Graves' Disease

Mental fatigue occurs in many diseases and the reasons are mostly unknown. The investigators hypothesize that remaining mental fatigue after restored euthyroidism in Graves' disease is an autoimmune complication. This is a confirmatory study of the biomarkers from ImmunoGraves WP1 in which immunological markers with possible association with mental fatigue in Graves' disease are explored. In ImmunoGraves WP2, 310 patients with Graves' disease are assessed for symptoms of mental fatigue, quality of life, anxiety and depression, self-evaluated stress, coping strategies, personality traits, eye symptoms and background variables. Participants are examined in hyperthyroidism at inclusion, within three weeks from diagnosis, and in euthyroidism after 15 months. Serum and cerebrospinal fluid (in a subsample of participants) is collected at both visits and will be evaluated for the immunological markers identified in WP1 as well as for thyroid hormones, thyroid autoantibodies and biomarkers indicating organic and structural nerve damage. Significant predictors for mental fatigue will be identified by logistic regression. To assess functional changes in the brain, magnetoencephalography will be performed in a subset of patients and in healthy controls at inclusion and after 15 to 18 months. Combined with magneto resonance imaging (MRI), magnetoencephalography gives information on neuronal activation during attention testing.

A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease

The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on antithyroid drugs (ATDs).

Prevalence and Predictors of Incidental Thyroid Carcinoma in Patients With Graves' Disease Undergoing Thyroidectomy.

The prevalence of incidental thyroid cancer (ITC) in Graves' Disease (GD) patients undergoing thyroidectomy appears higher than historically believed, potentially exceeding 10% in large contemporary series, although significant variability exists. The presence of nodules is a strong predictor, while the roles of age, sex, and BMI require clarification. Most ITCs are papillary thyroid microcarcinoma(PTMCs) with generally favorable prognoses, but concerns about aggressiveness persist. The purpose of the present study is to accurately evaluate the prevalence of incidental thyroid carcinoma (ITC), including microcarcinomas, in a prospectively enrolled cohort of patients undergoing total thyroidectomy for Graves' disease, utilizing standardized pathological examination protocols and secondary outcomes including predictors and histopathological characteristics.

Preoperative Corticosteroids in Autoimmune Thyroid Disease

This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.

Study of BHV-1300 in Graves' Disease

The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.

Telehealth Music Therapy for Adults With Endocrine Disorder and Depression

The goal of this clinical trial is to explore if a telehealth music therapy intervention helps with quality of life, depression symptoms, anxiety symptoms. It will also explore the participants' relationship to music. The main questions it aims to answer are: * Refine and tailor the music therapy intervention to fit the specific needs of adults living with an autoimmune disease and depression. * Examine the feasibility of the study protocol to support a future full-scale trial * Examine how music therapy impacts quality of life, depression symptoms, and anxiety symptoms * Explore how music therapy impacts one's relationship to music Participants will: * have a short interview to fill out a questionnaire with some basic information, answers about depression, quality of life, and potential anxiety, and a question about how they feel about music at the start and end of the sessions * attend 8 weekly sessions, approximately 30-45 minutes each, with a board certified music therapist over telehealth/Zoom * answer a few questions about the music therapy intervention

Screening, Classification, and Outcome Prediction Ensemble Using Orbital MRI for Thyroid Eye Disease: The TED SCOPE National Multicenter Registry Study

The goal of this observational study is to prospectively validate the efficacy of an AI multimodal model constructed based on multi - sequence orbital MRI in the diagnosis, activity and severity assessment, and prognosis prediction of thyroid - associated ophthalmopathy (TAO) in real - world clinical scenarios. The main questions it aims to answer are: Can AI models accurately assess the presence, activity, and severity of Thyroid-Associated Orbitopathy (TAO)? Can AI models predict the prognosis of TAO? Researchers will compare the diagnostic accuracy of the AI model for TAO patients and healthy subjects to evaluate its diagnostic performance. Participants will undergo a standardized, study - specific multimodal orbital MRI scan (sequences include T1WI, T2WI, STIR, and research sequences such as Magic, IDEAL - IQ, DWI, ASL, CEST). And will systematically acquire ocular ultrasound images from TED patients (active and inactive stages), non-TED ophthalmic disease controls, and healthy volunteers. AI-driven deep learning techniques (convolutional neural networks) will be applied to achieve automatic segmentation of key structures (extraocular muscles, optic nerve, lacrimal gland, and retrobulbar soft tissue). High-throughput radiomic features encompassing morphological parameters and gray-level texture patterns will be extracted. Machine learning algorithms will then be employed to construct objective prediction models for TED screening and activity staging, with MRI findings and CAS scores serving as the reference standards for external validation.

Evaluating an AI Tool for Detecting Thyrotoxic States

This observational study aims to evaluate the performance of a software-based medical device, Glandy HYPER, in detecting the thyrotoxic state in patients with hyperthyroidism. The device utilizes heart rate data collected from commercially available wearable devices and compares it with thyroid function test results. The study will enroll patients diagnosed with Graves' disease, monitoring their heart rate during sleep and correlating these measurements with free T4 levels obtained through serial blood testing. No investigational device output will be disclosed to participants, and the study will not alter standard clinical care.

BASE-DIET: a Study on Nutritional Intervention in Patients With Graves' Disease

The goal of this clinical trial is to determine whether a structured dietary-nutritional intervention can prevent excessive weight regain and improve body composition and lifestyle habits in adults recently diagnosed with Graves' disease (Basedow's disease). The main questions it aims to answer are: * Can a dietary intervention prevent patients from regaining more than 1 kg above their pre-disease body weight after restoring euthyroidism? * Does the intervention lead to improvements in body composition, dietary habits, and adherence to the Mediterranean diet? Researchers will compare patients receiving an Intensive Lifestyle Intervention (ILI) including a personalized diet and lifestyle counseling to patients receiving Usual Medical Care (UMC) with general lifestyle advice to see if the dietary intervention results in less weight regain and better metabolic and anthropometric outcomes. Participants will: * Receive antithyroid medication as standard medical care. * Be randomized into either the intervention group (ILI) or control group (UMC). If in the ILI group, participants will: * Receive an individual nutritional consultation within 1 week of enrollment. * Follow a personalized Mediterranean-style low-energy diet. * Attend follow-up visits at 3, 6, 9, and 12 months for: * Dietary adherence and lifestyle assessments. * Anthropometric measurements (weight, BMI, waist/hip circumference). * Bioimpedance analysis (at 6 and 12 months) for body composition. * Dietary intake logs and adherence assessments (3-day food diary). If in the UMC group, participants will: * Receive routine clinical management for Graves' disease. * Complete basic dietary and lifestyle questionnaires at baseline and 12 months. * Undergo anthropometric measurements and bioimpedance at T0 and at the end of study. This study aims to provide evidence on the role of nutritional support in managing weight and metabolic risks in patients undergoing treatment for Graves' disease.

Systemic Inflammation, Thyroid Autoimmunity and Neuroretinal Changes in Graves Disease

This retrospective observational study aims to evaluate the relationship between systemic inflammatory parameters, thyroid autoimmunity markers, and neuroretinal structures in patients with Graves disease. Medical records of patients diagnosed with Graves disease and healthy control subjects evaluated at Elazığ Fethi Sekin City Hospital between August 2018 and January 2026 will be reviewed. Optical coherence tomography (OCT) measurements, including macular thickness and peripapillary retinal nerve fiber layer (RNFL) thickness, will be analyzed. Laboratory parameters such as complete blood count-derived inflammatory indices, C-reactive protein, thyroid function tests, and thyroid autoantibodies will also be recorded. The study will compare neuroretinal parameters between healthy controls, Graves disease patients without ophthalmopathy, and Graves disease patients with ophthalmopathy, and will investigate potential associations between systemic inflammation, thyroid autoimmunity, and neuroretinal structural changes.

A Study of GensSci098 in Subjects With Graves' Disease

To evaluate the safety and tolerability of single ascending subcutaneous doses of GenSci098 in patients with Graves' Disease

Impact of Thyroid Hormones on Human Glucose and Energy Metabolism

The goal of this clinical trial to clarify the impact of changes in thyroid hormone levels on glucose and lipid metabolism. Patients will be included in whom thyroid hormone levels are intentionally changed by treatment. In patients with Graves' disease, thyroid hormone levels will be lowered using medication, while in patients with thyroid cancer, thyroid hormone levels will be raised using medication. Oral glucose tolerance tests will be performed before treatment and at two time points after treatment begins to assess metabolic effects.