[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acromegaly\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acromegaly":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,44,71,100,132,158,190,221,242,263,284,306,330,348,369,389],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100642561","an-observational-study-of-octreotide-subcutaneous-depot-in-patients-with-acromegaly-100642561",false,"NCT07583563","An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly","A Multi-Center, Multinational, Observational Study of Octreotide Subcutaneous Depot for the Treatment of Patients With Acromegaly","Inclusion Criteria:\n\n* Have started or will be starting treatment with octreotide SC depot for acromegaly\n\nExclusion Criteria:\n\n* Have started or will be starting treatment with octreotide SC depot for other conditions not related to acromegaly\n* Currently taking part in an interventional clinical trial or is still within a 30-day washout period from the end of taking part in an interventional clinical trial.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to collect long-term (up to two years) safety and effectiveness of octreotide subcutaneous depot in patients with acromegaly in the real-world setting.",[24],"Acromegaly",[26,24,27,28,29,30],"Octreotide subcutaneous depot","Observational","Real-world","Safety","Tolerability","RECRUITING","2026-06-26",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2026-06-05",{"date":39,"type":20},"2029-06",{"name":41,"class":42},"Camurus AB","INDUSTRY",5,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100644331","phase-1-a-phase-1-study-to-evaluate-the-relative-bioavailability-of-octreotide-acetate-tabletst25-compared-to-mycapssa-and-the-food-effect-on-pharmacokinetics-of-octreotide-acetate-tabletst25-100644331","NCT07663318","A Phase 1 Study to Evaluate the Relative Bioavailability of Octreotide Acetate Tablets(T25) Compared to MYCAPSSA® and The Food Effect on Pharmacokinetics Of Octreotide Acetate Tablets(T25)","A Phase 1, Single-center, Open-Label, Randomized, Three-Period, Six-Sequence, Single-Dose, Crossover Study in Healthy Participants Under Fasted or Fed Condition to Compare the Relative Bioavailability of Orally Administrated Octreotide Acetate Tablets (T25) and Orally Administrated Octreotide Acetate Delayed-Release Capsules (MYCAPSSA®) and to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25","Inclusion Criteria:\n\n1. Healthy male or female aged 18 to 55 years (both inclusive).\n2. Participants with a body mass index (BMI, weight \\[kg\\]\u002Fheight2 \\[m2\\]) within 19-28 kg\u002Fm2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female.\n3. Participants with good physical condition, without any history of disease or clinically relevantly abnormal vital signs or physical examination. Participants in good general health, without clinically significant physical examination, vital signs, laboratory tests, ECGs, or abdominal ultrasound findings at Screening or Check-in (Day -2) that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results\n4. Participants with childbearing potential must agree to use adequate contraception and have no plan for pregnancy from screening period throughout 3 months after the last dose of investigational product; Women of childbearing potential (WOCBP) must have a negative blood pregnancy test prior to the first dose of investigational products. Note: WOCBP are defined as females who have reached menarche but have not yet undergone menopause (defined as ≥12 consecutive months of amenorrhea for non-pathological reasons) and have not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n5. Participants must fully understand and voluntarily sign the informed consent form prior to the initiation of any study procedures.\n6. Participants with high compliance for all protocol requirements.\n\nExclusion Criteria:\n\n1. Participants with allergic disease or allergic to investigational products or its excipients, or more than two kinds of medications, food, or beverage.\n2. Participants with positive for human immunodeficiency virus (HIV) antibody test; active infection with Hepatitis B, C; positive treponema pallidum antibody test.\n3. Participants with a history of chronic or severe diseases involving the cardiovascular, hepatic, renal, gall biliary, respiratory, hematologic\u002Flymphatic, endocrine, immune, psychiatric, neuromuscular, or GI systems from one year prior to the first dose of study drug; or with a history (or a current condition) of GI disorders during this period, such as chronic or active upper GI diseases (e.g., esophageal disorders, gastritis, duodenitis, peptic ulcers), active GI bleeding, or history of GI surgery, as determined by the Investigator, may impact the ability of the subject to participate or potentially confound the study results.\n4. Participants who have received a radiation dose exceeding 5 mSv within the past 12 months (e.g., more than 2 cranial CT scans \\[approximately 2 mSv per scan\\], more than 3 low-dose chest CT scans \\[approximately 1.5 mSv per scan\\], more than 1 standard chest CT scan \\[4-7 mSv per scan\\], or more than 1 abdominal CT scan \\[8 mSv per scan\\]), or have received a total radiation dose over 10 mSv in the preceding 5 years, or are scheduled to undergo additional radiological examinations during the trial or within one year after the completion of the trial.\n5. AST \\> ULN or bilirubin \\> ULN.\n6. Creatinine clearance \\\u003C90 mL\u002Fmin during screening (calculation formula of Creatinine Clearance is detailed in Section 8.2.1.6).\n7. Participants with a history or presence of hypothyroidism.\n8. Participants with a history of drug abuse within 5 years or intake of any narcotics within 6 months before the initial administration, or who have a positive drug abuse test on admission.\n9. Participants with a history of alcohol abuse within 6 months before the initial administration, defined as an average alcohol intake \\> 2 units\u002Fday (1 unit of alcohol = 285 mL beer, or 25 mL spirits, or 100 mL wine).\n10. Participants with a history of smoking \\> 5 cigarettes\u002Fday within 3 months before the initial administration or unable to refrain from using any tobacco or nicotine-containing product within 48 hours prior to administration and during hospitalization.\n11. Participants who have donated or lost blood \\> 400 mL within 3 months before the initial administration.\n12. Participants who have received major surgery or hospitalized within 3 months before the initial administration.\n13. Participants who have received investigational drugs or participated in other clinical trials within 3 months before the initial administration.\n14. Participants who have received prescription drug within 14 days before the initial administration.\n15. Participants who have taken high-density medications such as bismuth agents and calcium agents within 7 days before the initial administration.\n16. Participants who have received over the counter (OTC) drug or herb within 7 days before the initial administration.\n17. Participants who have consumed grapefruit juice, or other food or beverage containing caffeine or xanthine within 7 days before the initial administration.\n18. Participants who have drunk alcohol within 48 hours before the initial administration or with a positive breath alcohol test (\\> 0 mg\u002F100 mL).\n19. Participants cannot receive standard meals during the study.\n20. Participants who cannot tolerate venipuncture or have a history of fear of needles or hemophobia.\n21. Participants with vitamin B12 deficiency.\n22. Participants with acute minor diseases (common cold, diarrhea, etc.) during screening.\n23. For female participants, breastfeeding or positive for pregnancy test at screening, or who have unprotected sexual contact within 2 weeks before dosing, or who have intrauterine devices in their bodies.\n24. Participants who are not suitable for participating in this study due to other reasons as judged by Investigator.",true,"55 Years",{"count":54,"type":20},18,"INTERVENTIONAL",[57],"PHASE1","The goal of this clinical trial\\] is to to Assess the Food Effect on the Relative Bioavailability of Orally Administrated T25 in healthy volunteers. The main questions it aims to answer are：\n\n1. How much of relative bioavailability of Orally Administrated T25 compared to Mycapssa？\n2. What effects does of food have on the pharmacokinetic profile of T25 when administerted under high fat diet?\n\nParticipants will:\n\nTake T25 under both fast and food state or mycapssa in under fast state in Day1, Day4, and Day7, 13. A follow-up visit is scheduled on D14+(7), which is 7\\~14 days after the last dose of investigational product via phone\u002Fmessage\u002FWeChat or in face-to-face manner.",[24],[61],"Octreotide","NOT_YET_RECRUITING","2026-06-25",{"date":65,"type":35},"2026-06-29",{"date":32,"type":20},{"date":68,"type":20},"2026-09-30",{"name":70,"class":42},"Triastek (Shanghai) Limited",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":55,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100587610","phase-3-a-study-to-assess-the-efficacy-and-safety-of-debio-4126-in-participants-with-acromegaly-previously-treated-with-somatostatin-analogs-100587610","NCT06930625","A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs","A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs","OXTEND™-03","Inclusion criteria\n\n1. Patients ≥18 years of age\n2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.\n3. IGF-1 at screening ≤1x ULN\n4. Acromegaly diagnosis, defined as per protocol\n5. Adequate bone marrow, hepatic and renal function\n6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication\n7. Other protocol-defined criteria apply\n\nExclusion criteria\n\n1. Compression of optic chiasm causing visual defects\n2. Symptomatic cholelithiasis or bile duct dilatation\n3. Planned cholecystectomy during the trial duration\n4. Acute or chronic pancreatitis\n5. Pituitary radiotherapy\n6. Uncontrolled hypothyroidism\n7. Uncontrolled diabetes\n8. Pituitary surgery within 6 months before screening or planned on trial\n9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening\n10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism\n11. Other protocol-defined criteria apply",{"count":80,"type":20},119,[82],"PHASE3","The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.",[24],[86,87,88,89],"IGF-1","Growth hormone","Pituitary gland","Gigantism","2026-06-21",{"date":92,"type":35},"2026-06-23",{"date":94,"type":35},"2025-11-26",{"date":96,"type":20},"2029-03",{"name":98,"class":42},"Debiopharm International SA",72,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100641846","direct-versus-video-laryngoscopy-in-patients-with-acromegaly-100641846","NCT07659912","Direct Versus Video Laryngoscopy in Patients With Acromegaly","Determination of the Appropriate Intubation Method in Patients With Acromegaly: Comparison of Direct Laryngoscopy and Video Laryngoscopy","ACRO-VL","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of acromegaly and scheduled for surgery after evaluation by the institutional pituitary diseases council\n* Diagnosis of nonfunctioning pituitary adenoma and scheduled for surgery after evaluation by the institutional pituitary diseases council\n* Requirement for general anesthesia with endotracheal intubation\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Refusal to participate in the study\n* Presence of extrapituitary malignancy\n* Emergency surgery\n* Previous tracheostomy or major laryngeal\u002Ftracheal surgery\n* Severe limitation of mouth opening preventing standard laryngoscopic evaluation\n* Cervical spine instability or severe restriction of neck extension\n* Patients requiring awake fiberoptic intubation according to preoperative airway assessment\n* Patients for whom participation is considered unsafe by the responsible anesthesiologist",{"count":109,"type":20},40,"Acromegaly is associated with craniofacial skeletal changes and upper airway soft tissue hypertrophy, which may increase the risk of difficult laryngoscopy and tracheal intubation. This prospective observational study aims to evaluate airway and intubation characteristics in patients with acromegaly undergoing surgery under general anesthesia and to compare direct laryngoscopy and video laryngoscopy findings.\n\nAdult patients with acromegaly and patients with nonfunctioning pituitary adenomas scheduled for surgery under general anesthesia will be prospectively enrolled between July 1, 2026, and August 31, 2026. Preoperative airway assessment parameters, hormonal data including growth hormone and insulin-like growth factor-1 levels, Mallampati score, modified Cormack-Lehane grade, intubation-related variables, and peri-intubation complications will be recorded.",[24,112],"Nonfunctioning Pituitary Adenoma",[24,114,115,116,117,118,119,120,121],"Difficult Intubation","Direct Laryngoscopy","Video Laryngoscopy","Cormack-Lehane Classification","Airway Management","Growth Hormone","Insulin-Like Growth Factor 1","Pituitary Adenoma","2026-06-17",{"date":124,"type":35},"2026-06-22",{"date":126,"type":20},"2026-07-01",{"date":128,"type":20},"2026-08-31",{"name":130,"class":131},"Muzaffer GENCER","OTHER_GOV",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":55,"phases":141,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100642607","phase-2-a-study-to-evaluate-mar002-for-acromegaly-100642607","NCT07641179","A Study to Evaluate MAR002 for Acromegaly","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo- Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR002 in Participants With Acromegaly (TROUGH-2)","Inclusion Criteria:\n\n1. Willing to provide written informed consent and comply with study procedures as specified in this protocol and comply with study treatment.\n2. Age 18 to 75 years (inclusive) at screening with active acromegaly confirmed by an endocrinologist specialized in the care of pituitary patients. At a minimum, there must be documentation of a pituitary tumor (e.g., imaging evidence of a pituitary tumor by magnetic resonance imaging \\[MRI\\]\u002Fcomputerized tomography \\[CT\\] or histopathologic evidence of pituitary adenoma following pituitary surgery) and an elevated IGF-1 in the past.\n3. Participants receiving acromegaly medical therapy at screening (i.e., Group 2 and Group 3) may be enrolled if the regimen is considered stable by the Investigator and must agree to wash out acromegaly treatment, if applicable per protocol.\n4. Average serum IGF-1 level of ≥ 1.3 × ULN defined as the mean of 2 measurements obtained ≥ 1 week apart during Screening.\n5. Participants with hypothyroidism and adrenal insufficiency should have these hormone axes adequately replaced as judged by the Investigator.\n6. Weight ≥ 50 kg at screening.\n\nExclusion Criteria:\n\n1. History of hypersensitivity to monoclonal antibodies.\n2. Participation in any other investigational drug study and received the last dose of investigational drug within 60 days or 5 half-lives (whichever is longer) of SV1.\n3. History of severe allergic or anaphylactic reactions.\n4. History of malignancy within 5 years prior to screening other than successfully treated basal or squamous cell carcinoma or localized cervical carcinoma. Any carcinoma in situ is allowed if appropriately treated within 2 years prior to screening. Subjects with a history of malignancy ≥ 5 years prior to screening should be considered cured of their oncological disease.\n5. Pituitary surgery in the past 6 months prior to screening or any prior use of pituitary radiation therapy.\n6. Pituitary adenoma with concern for mass effect on the optic chiasm or other critical structures within the study period as per judgment of the Investigator.\n7. Poorly controlled diabetes mellitus, defined as having a hemoglobin A1c (HbA1c) ≥ 9.0%.\n8. Severe renal insufficiency (estimated glomerular filtration rate \\[eGFR by Chronic Kidney Disease Epidemiology Collaboration\\] \\\u003C 30 mL\u002Fmin\u002F1.73 m2) or significant liver disease (including cirrhosis) prior to randomization.\n9. History or evidence of any of the following within the previous 12 months: myocardial infarction, cardiac surgery revascularization (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty), hospitalization for heart failure, or stroke or transient ischemic attack.","75 Years",{"count":99,"type":20},[142],"PHASE2","Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in participants with acromegaly",[24],[146,147,148],"Marea","MAR002","MAR-202","2026-06-10",{"date":151,"type":35},"2026-06-12",{"date":153,"type":20},"2026-07",{"date":155,"type":20},"2027-12",{"name":157,"class":42},"Marea Therapeutics",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":164,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":167,"conditions":168,"keywords":173,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":189},"100092282","genetics-of-endocrine-tumours---familial-isolated-pituitary-adenoma---fipa-100092282","NCT00461188","Genetics of Endocrine Tumours - Familial Isolated Pituitary Adenoma - FIPA","Inclusion Criteria:\n\n* Familial acromegaly or other type of pituitary tumour OR\n* Early onset acromegaly or\n* Sporadic pituitary tumour\n\nExclusion Criteria:\n\n* Do not consent","6 Years",{"count":166,"type":20},10000,"The research is aimed at identifying new predisposition genes for endocrine tumours. Our focus initially is on pituitary adenomas including growth hormone-secreting tumors (somatotrophinomas) and prolactin secreting tumours (prolactinomas), but we wish to extend work to other pituitary tumour cases\u002Ffamilies.\n\nThe recruitment process will be as follows.\n\n1. We will recruit patients from our own Endocrine outpatient clinics and inpatient wards. In addition we will ask colleagues in other Endocrinology Departments (or other specialties such as Clinical Genetics,Pathology, General Medicine ) to identify potentially suitable patients with endocrine \\& pituitary tumours from their records. We shall focus on patients with good evidence of inheritance of their condition: relatively early onset; or multiple lesions; or other affected family members. Conditions where the predisposing genes have been identified (principally MEN) will be excluded from study. Patients directly contacting us can also enter the study.\n2. The Consultant looking after the patient will contact the patient to initially inform him\u002Fher of the study.\n3. We will then contact the patient (generally by telephone) to discuss the study and what it would entail in terms of information and samples.\n4. Subject to agreement in (3), patient will receive 'Information Sheet for patients with pituitary tumour' and 'Consent Form' and will have blood sampling in Consultant's clinic.\n5. We will contact additional family members (if appropriate) after an initial approach by the family member already recruited to the study. The additional family members may have developed tumours similar to those of the proband, or may be unaffected individuals who provide useful information for gene identification purposes (for example, spouses may greatly aid the power of gene mapping by linkage. They will receive the \"Information Sheet for family members\". analysis).\n\n8\\. Archival tissue will be obtained from HTA licensed tissue banks. This is an established bank whose licence is primarily for diagnosis but can be used for research. 9. We will undertake laboratory work, such as genetic linkage analysis, candidate gene mutation screening and studies of loss of heterozygosity in tumours, to identify the genes predisposing to the condition, such as the AIP gene. In addition we would like to screen other genes related to the chaperon AIP molecule, such as AhR, and other genes currently identified (PDE4A5, survivin and Tom20 protein) or may not been identified.\n\nBlood samples for DNA and RNA will coded with unique ID numbers. Pituitary and other endocrine tumour samples will be collected at surgery and kept in liquid nitrogen or -80 C. They will be coded with unique ID numbers. Candidate gene sequencing will be performed in the Barts and the London Medical School Genome Centre.\n\nRNA expression studies from blood or adenoma tissue samples will be performed by RT-PCR. Protein expression studies will be performed by Western blotting or immunohistochemistry. The first gene we wish to study causes familial acromegaly, a disease resulting from a pituitary adenoma secreting growth hormone.\n\nTo establish if the candidate gene is also causing possibly sporadic (not familial) cases of the disease, samples (blood and tissue) will be collected from patients with sporadic disease and will be analysed as above.",[24,89,169,170,171,172],"Familial Isolated Pituitary Adenoma","FIPA","Pituitary Adenoma Predisposition","PAP",[174,175,176,177,169,170,178,172],"acromegaly","gigantism","familial pituitary adenoma","Familial acromegaly","Pituitary adenoma predisposition","2026-05-18",{"date":181,"type":35},"2026-05-20",{"date":183,"type":35},"2007-03-01",{"date":185,"type":20},"2037-12-31",{"name":187,"class":188},"Barts & The London NHS Trust","OTHER",3,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":55,"phases":201,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100595820","phase-2-alxn2420-versus-placebo-in-combination-with-somatostatin-analogs-in-participants-with-acromegaly-100595820","NCT07037420","ALXN2420 Versus Placebo in Combination With Somatostatin Analogs in Participants With Acromegaly","A Phase 2, Randomized, Double-blinded, Placebo-controlled, Dose Range-finding, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALXN2420, a Growth Hormone Receptor Antagonist, Administered Subcutaneously in Combination With Somatostatin Analogs in Adult Participants With Acromegaly","ASTERIA","Inclusion Criteria:\n\n* Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report\n* Must be receiving maximum, or maximally tolerated dose per treating physician judgment, of long-acting SSAs (octreotide or lanreotide LAR) and meet both of the following:\n\n  1. Received for ≥ 6 months prior to screening\n  2. Receiving a once-monthly regimen (approximately every 4 weeks). Note: participants on stable regimens of other durations (for example, every 3 or 6 weeks) are not eligible\n* Must be a partial responder to SSAs defined as \\> 20% relative IGF 1 reduction during the course of SSA therapy\n* Serum IGF-1 levels \\> 1.3 to 5\\*ULN inclusive, as assessed at a central laboratory and adjusted for age and sex, based on average of 2 consecutive values obtained during the Screening Period and obtained ≥ 7 days apart\n\nExclusion Criteria:\n\n* Had surgery for pituitary adenoma within the last 6 months before Day 1 or planning to receive surgery for pituitary adenoma during the study\n* Pituitary adenoma that, per Investigator's judgment, is worsening as assessed by pituitary\u002Fsellar MRI or computed tomography scan obtained ≤ 6 months prior to screening\n* Pituitary adenoma causing compression of the chiasm\n* Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment with dopamine agonists\n* Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or glucocorticoid hormone replacement therapy for ≥ 3 months prior to Screening\n* Active, clinically significant cardiac disease as judged by the Investigator\n* History of unstable angina, stroke, or acute myocardial infarction ≤ 3 months prior to screening\n* Known uncontrolled type 2 diabetes (HbA1c \\> 10%)\n* Active malignant disease ≤ 2 years prior to screening with exception of basal and squamous cell carcinoma of the skin\n* Received any type of fractionated radiotherapy or a second surgical adenectomy for pituitary adenoma within the last 3 years (5 years for conventional radiation) before starting treatment and\u002For are planning to receive radiotherapy or a second surgical adenectomy during the study\n* Received pegvisomant ≤ 8 weeks prior to screening\n* Received dopamine agonists ≤ 4 weeks prior to screening\n* Received pasireotide LAR ≤ 4 months prior to screening\n* Clinically significant renal or hepatic disease at the time of screening, as judged by the Investigator\n* eGFR (CKD-EPI formula) \\\u003C 30 mL\u002Fminute\u002F1.73 m\\^2 documented based on recent value (\\\u003C 3 months prior to randomization)\n* Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis, as judged by the Investigator, including, but not limited to, total bilirubin \\> 1.5\\*ULN (except if in free bilirubin linked to a known Gilbert Syndrome) or AST, ALT, or alkaline phosphatase \\> 2\\*ULN","80 Years",{"count":200,"type":20},60,[142],"The primary objective of this study is to evaluate the efficacy of 15-week treatment with ALXN2420 versus placebo for decreasing insulin-like growth factor IGF-1 levels, when administered in combination with somatostatin analog (SSA) therapy to adult participants with acromegaly.",[24],[24,205,206,207,86,208,209,210],"ALXN2420","Somatostatin Analog","insulin-like growth factor 1","SSA therapy","GHRA","Growth Hormone Receptor Antagonist","2026-04-06",{"date":213,"type":35},"2026-04-07",{"date":215,"type":35},"2025-10-28",{"date":217,"type":20},"2027-11-11",{"name":219,"class":42},"Alexion Pharmaceuticals, Inc.",45,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":51,"sex":228,"minAge":17,"maxAge":229,"enrollmentInfo":230,"targetDuration":4,"studyType":55,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":240,"locationsCount":241},"100607947","phase-1-study-of-mar002-in-healthy-men-100607947","NCT07195175","Study of MAR002 in Healthy Men","First in Human, Randomized, Blinded, Placebo-Controlled Single Ascending Dose and Multiple Dose Study of MAR002 in Healthy Men","Inclusion Criteria:\n\n1. Willingness to provide written informed consent\n2. Age 18 to 40\n3. Weight 55 to 95 kg\n4. Body mass index (BMI) 18 to 30 kg\u002Fm2\n5. Healthy men\n\nExclusion Criteria:\n\n1. History of hypersensitivity to monoclonal antibodies or study drug\n2. Participation in any other investigational drug study\n3. History of cancer\n4. Recent acute illness\n5. Positive test for HIV, hepatitis B\u002FC\n6. History of substance abuse or nicotine use\n7. Recent blood donation\n8. History of pituitary disorder\n9. Any condition that prevents the participant from complying with study procedures","MALE","40 Years",{"count":220,"type":20},[57],"Evaluate the safety and tolerability of subcutaneous (SC) administration of MAR002 in healthy men",[24],"2026-01-08",{"date":236,"type":35},"2026-01-12",{"date":238,"type":35},"2025-08-11",{"date":153,"type":20},{"name":157,"class":42},1,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":251,"conditions":252,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":241},"100606774","effects-of-pasireotide-lar-therapy-on-bone-metabolism-100606774","NCT07179926","Effects of Pasireotide Lar Therapy on Bone Metabolism","Pasi-Bone","INCLUSION CRITERIA FOR THE PROSPECTIVE COHORT\n\n* adult patients (\\>18 years)\n* acromegaly not-controlled after 6 months of treatment with fg-SRLs and switched since at least one week, to Pasireotide LAR, according to clinical practice and actual experts consensus,\n* signing of informed consent\n\nINCLUSION CRITERIA FOR THE RETROSPECTIVE COHORT\n\n* adult patients (\\>18 years)\n* acromegaly not-controlled after 6 months of treatment with fg-SRLs and switched to Pegvisomant, according to clinical practice and actual experts' consensus,\n* signing of informed consent or substitute declaration on the consent form where applicable.\n\nExclusion Criteria:\n\n* patients under the age of 18 years.",{"count":250,"type":20},120,"Acromegaly, a chronic condition characterized by growth hormone (GH) and, in turn, insulin-like growth factor-1 (IGF-I) excess, is burdened by a series of systemic and metabolic comorbidities that strongly impair quality of life (QoL) and life expectancy. Amongst them, a specific acromegalic osteopathy has been discovered, characterized by fragility fractures associated with high bone turnover, which need to be early detected, according to most recent guidelines, since they are very frequent and related to chronic pain and reduced QoL. Morphometric vertebral fractures (VFs) are an emerging landmark of skeletal fragility in general population as well as in clinical trials, and are highly prevalent in acromegaly, being reported to affect from 30 up to 60% of patients and represent an early and common event in disease history. Until now, same groups of patients with higher risk of vertebral fractures were identified, such as those carrying incident vertebral fractures, or affected by biochemical active acromegaly, concomitant hypogonadism, or diabetes mellitus. The main aim in the management of patients with acromegaly is to normalize IGF-I levels and restore acromegaly related symptoms. To aim this treatment objective, the first line of treatment of acromegaly, when feasible, is neurosurgery. In cases where surgical intervention fails to achieve biochemical control, medical therapy is recommended, with the objective of reaching normal levels of IGF-1 and GH age-corrected. Octreotide LAR and Lanreotide are the first-line medical therapy. In patients who have not achieved adequate control with standard doses of octreotide LAR and Lanreotide, increasing the dose and\u002For frequency of administration can lead to improved biochemical control. In patients who are unable to achieve control even with this approach, a switch to Pasireotide LAR may be considered. In instances where patients fail to achieve biochemical control with maximal doses of SRL, or in the presence of contraindications, the use of Pegvisomant as a second-line therapy may be considered. In addition, a combination of Pegvisomant and SRL represents a potential avenue for treating patients. Prevention of VFs in acromegaly remains an open issue. It has been shown that use of GH\u002FIGF-I lowering treatments with first-generation SSA and Pegvisomant, may reduce the risk of VFs, while improving disease control. Moreover, in a retrospective and observational multicenter study, it was recently proved that patients treated with second generation SRLs (Pasireotide-LAR) developed less frequently VFs then patients treated with Pegvisomant.",[253,24],"Acromegaly Due to Pituitary Adenoma","2025-09-11",{"date":256,"type":35},"2025-09-18",{"date":258,"type":35},"2025-09-08",{"date":260,"type":20},"2028-06",{"name":262,"class":188},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":241},"100513380","effects-of-therapies-in-the-acromegaly-disease-acral-morpho-functional-study-100513380","NCT05964712","Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study","ACROMORFO","Inclusion Criteria:\n\n* De novo patients with acromegaly (group # 1), diagnosed according to Endocrine Society guidelines,\n* Age equal to18 years or older\n* Acromegalic patients with different disease status (group #2)\n* Age equal to18 years or older\n\nExclusion Criteria:\n\n* Cardiorespiratory, neurological or musculoskeletal disorder\n* Previous orthopaedic surgery\n* Previous lower limbs traumatic injuries","90 Years",{"count":272,"type":20},30,"Acromegaly is a rare chronic disease due to excessive secretion of growth hormone (GH) and insulin-like growth factor-I (IGF-I), caused in over 98% of cases by GH-secreting pituitary adenoma. Prolonged exposure to GH\u002FIGF-I excess is the cause of increased mortality and morbidity in these patients. Arthropathy occurs in about 75% of acromegalic patients. Any joint may be affected, with the development of osteoarthritis, arthralgia, and an increase in fracture risk.\n\nThe aims of the present project are to evaluate the dimensions of hands and feet with the 3D scanner method and to perform a quantitative analysis of movement through Gait Analysis technique in de novo patients with acromegaly (group # 1) and in patients with different disease status (group #2).",[24],"2025-08-01",{"date":277,"type":35},"2025-08-03",{"date":279,"type":35},"2019-06-18",{"date":281,"type":20},"2025-12-31",{"name":283,"class":188},"Istituto Auxologico Italiano",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":293,"conditions":294,"keywords":295,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":241},"100449332","korean-regulatory-post-marketing-surveillance-for-somavert-100449332","NCT05131100","Korean Regulatory Post Marketing Surveillance for Somavert","Korean Post-marketing Surveillance for Somavert","Inclusion Criteria:\n\nAll patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.\n\nExclusion Criteria:\n\nPatients who are contraindicated for Somavert",{"count":292,"type":20},100,"Non-interventional observational study, to identify safety and effectiveness of Somavert during the post-marketing period based on the Korean RMP as required by the regulations of Ministry of Food and Drug Safety (MFDS)",[24],[296],"acromegaly, Somavert, Post-Marketing Surveillance","2025-07-02",{"date":299,"type":35},"2025-07-04",{"date":301,"type":35},"2022-07-13",{"date":303,"type":20},"2026-09-15",{"name":305,"class":42},"Pfizer",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":241},"100561993","the-rapid-switch-from-1st-generation-somatostatin-analogues-to-pasireotide-in-acromegaly-100561993","NCT06597383","The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly","The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly ( RAPSODIA )","RAPSODIA","Inclusion Criteria:\n\n* Adult men and women (age ≥ 18 years) affected by acromegaly, including those of childbearing age\n* Patients inadequately controlled with first generation somatostatin analogues (GH ≥1 μg\u002FL and IGF-1 \\>1.3×ULN)\n* Second line medical treatment (Pasireotide; Pegvisomant only; combination Pegvisomant + 1st generation SSA) after use of first-line medical treatment\n* At least 12 months of follow up during 2nd line therapy\n* Signature of the informed consent to the study\n\nExclusion Criteria:\n\n* age ≤18 years\n* Pregnant and\u002For breastfeeding women\n* Patients unable to understand and sign the Informed Consent",{"count":292,"type":20},"This is an observational, retrospective, national multicenter study aimed to evaluate the impact and efficacy of Time To Switch (TTS) from first-line to second-line medical therapy in Acromegaly.",[24],[318,319,320],"somatostatin analogues","pasireotide","pegvisomant","2024-09-11",{"date":323,"type":35},"2024-09-19",{"date":325,"type":35},"2023-11-24",{"date":327,"type":20},"2024-11",{"name":329,"class":188},"IRCCS San Raffaele",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":241},"100542575","cellular-molecular-and-clinical-determinants-of-bone-strength-in-in-vivo-and-human-models-of-gh-excess-100542575","NCT06344650","Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess.","Cellular, Molecular and Clinical Determinants of Bone Strength in in Vivo and Human Models of GH Excess. Cross-sectional and Prospective Study","Inclusion Criteria:\n\n* confirmed diagnosis of acromegaly\n* availability to carry out outpatient checks\n* ability to provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* use of glucocorticoids (except those in use for replacement therapy)\n* alcohol abuse\n* exacerbation of chronic disease\n* serious comorbidities (renal or hepatic failure, heart attack, stroke)\n* terminally ill, prolonged immobilization (\\>1 week)\n* clinically evident fracture within the previous six months\n* any other cause of secondary osteoporosis within the last five years\n* any prolonged treatment with drugs with documented influence on bone metabolism during the previous 12 months, including treatment with antiresorptive or anabolic compounds for osteoporosis.",{"count":292,"type":20},"Prospective observational clinical, molecular, translational study aimed at identifying the main determinants and predictive factors of fragility fracture risck in acromegaly patients",[24],"2024-08-20",{"date":342,"type":35},"2024-08-22",{"date":344,"type":35},"2023-04-30",{"date":346,"type":20},"2026-04",{"name":329,"class":188},{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":4},"100541207","neuroendocrine-mechanisms-in-adiposity-an-integrated-approach-to-the-characterization-of-potential-pharmacological-novel-targets-based-on-experimental-and-clinical-models-100541207","NCT06326853","Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models","Inclusion Criteria:\n\nObese patients affected and not by hypothalamic-pituitary diseases\n\nExclusion Criteria:\n\n1. Minor subjects;\n2. Pregnant and\u002For breastfeeding women;\n3. Patients suffering from states of primary and\u002For acquired immunodeficiencies, and\u002For serious impairment of general clinical conditions (e.g. metastatic neoplasms; immunosuppressive therapies; worsening\u002Freacerbated\u002Fcompensated chronic pathologies);\n4. Patients unable to understand and sign the Informed Consent.",{"count":19,"type":20},"The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle\u002Fbone tissue",[357,358,121,359,24,360],"Endocrine Disorders","Adiposity","Cushing Syndrome","Hypopituitarism","2024-06-10",{"date":363,"type":35},"2024-06-11",{"date":365,"type":20},"2024-07",{"date":367,"type":20},"2026-12",{"name":329,"class":188},{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":139,"enrollmentInfo":375,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":241},"100297905","the-longitudinal-approach-to-acromegaly-a-pattern-of-treatment-and-comparative-effectiveness-research-100297905","NCT03158090","The Longitudinal Approach to Acromegaly: A Pattern of Treatment and Comparative Effectiveness Research","Inclusion Criteria:\n\n1. Be able and willing to sign the informed consent form (ICF)\n2. Male, female, age 18-75 years old (including 18 years old and 75 years old).\n3. Compliance with acromegaly diagnostic criteria:\n\n   * At least one laboratory or medical record shows that the patient is random GH ≥ 2.5 μg \u002F L\n   * At least one checklist or medical record shows radiographic evidence that the patient has a pituitary tumor\n\nExclusion Criteria:\n\n1. Ectopic secretion of GH or pituitary cancer\n2. The patient is diagnosed with other complicated malignancies, or has previously been diagnosed with another malignancy, and there is currently evidence of lesion residue.\n3. Have a diagnosis of other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the Investigator, would make the patient inappropriate for enrollment in this study.\n4. Be a patient who, in the judgement of the Investigator, would be inappropriate for enrollment in this study",{"count":376,"type":20},1965,"This study is a prospective, noninteractive, observational, and longitudinal study aimed at assessing the treatment pattern and clinical outcome of acromegaly in China.",[24],[24],"2022-03-14",{"date":382,"type":35},"2022-03-16",{"date":384,"type":35},"2017-12-15",{"date":386,"type":20},"2051-01-30",{"name":388,"class":188},"Ginkgo Leaf Center for Rare Disorders",{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":51,"sex":16,"minAge":395,"maxAge":198,"enrollmentInfo":396,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":241},"100288998","developing-a-simple-recognition-system-of-acromegaly-100288998","NCT03042026","Developing a Simple Recognition System of Acromegaly","Inclusion Criteria:\n\n* Age 20-80 years old, Acromegaly patients or Healthy Adults\n\nExclusion Criteria:\n\n* Pregnancy. Age less than 20 years old or older than 80 years old","20 Years",{"count":397,"type":20},80,"We will compare the features of 3D stereophotography of acromegaly patients with that of healthy people. We hope to develop a computerized model to help screening acromegaly patients for early detection and treatment.",[24],"2017-02-05",{"date":402,"type":20},"2017-02-07",{"date":404,"type":35},"2012-06-01",{"date":406,"type":20},"2027-06-01",{"name":408,"class":188},"National Taiwan University Hospital"]