[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adult-growth-hormone-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adult-growth-hormone-deficiency":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,76,105,131],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100429072","phase-3-growth-hormone-replacement-therapy-in-veterans-with-mild-traumatic-brain-injury-mtbi-and-adult-growth-hormone-deficiency-aghd-100429072",false,"NCT04867317","Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)","CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)","GRIT","Inclusion Criteria:\n\n1. OEF\u002FOIF\u002FOND Veteran\n2. Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)\n3. Age 21 - 55 years old\n4. One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey.\n5. GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg\u002FL), or glucagon stimulation test (cut point: 3 mcg\u002FL for BMI up to 25; cut point 1 mcg\u002FL for BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline\n6. Score of 11 or more on QoL-AGHDA\n7. 4-week stability on any psychotropic medications\n8. 3-month stability on all other hormone treatments\n9. Able and willing to provide informed consent to participate in this study, and complete study protocol.\n\nExclusion Criteria:\n\n1. History of moderate or severe TBI\n2. History of neurologic disorder other than TBI with substantial impact on quality of life\n3. History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder\n4. Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months.\n5. Contraindication to rhGH therapy\n6. Acute medical illness, active infection, cancer or decompensated chronic medical illness\n7. Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed.\n8. Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory and Malingering (TOMM).\n9. BMI \\> 40 or body weight \\> 350 lbs\n10. Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass)\n11. Women who are pregnant or of child-bearing potential not on contraception\n12. Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses\n13. Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)","ALL","21 Years","55 Years",{"count":21,"type":22},172,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).",[28,29],"Adult Growth Hormone Deficiency","Mild Traumatic Brain Injury","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2025-01-13",{"date":38,"type":22},"2029-09-30",{"name":40,"class":41},"VA Office of Research and Development","FED",17,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100635370","phase-2-safety-pharmacokinetic-pk-profile-and-efficacy-of-inpegsomatropin-injection-in-adults-with-growth-hormone-deficiency-100635370","NCT07551804","Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency","A Multiple-Dose, Dose-Escalation, Randomized, Double-Blind, Placebo-Controlled Phase Ⅱa Clinical Trial to Evaluate the Safety, Pharmacokinetic (PK) Profile and Preliminary Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency","Inclusion Criteria:\n\n* Male study participants aged ≥ 18 years and \\\u003C 80 years at the time of signing the informed consent form (ICF);\n* Study participants meeting the criteria for adult growth hormone deficiency (AGHD):\n\nPatients with a peak GH level \\\u003C 5 μg\u002FL measured by insulin tolerance test (ITT); OR Patients with an IGF-1 level below -2.0 SDS for age and sex at screening (see Appendix 4);\n\n* No systemic treatment with growth hormone or growth hormone secretagogues within 6 months prior to entering the screening period;\n* For patients with any other pituitary hormone deficiency who are on hormone replacement therapy (HRT) at screening, HRT must have been stable for at least 3 months;\n* Study participants must agree to use reliable contraceptive measures with their spouses from - Study participants fully understand the purpose, nature, methods and potential adverse reactions of the trial, voluntarily participate in the study, and have signed the informed consent form.\n\nExclusion Criteria:\n\n* Individuals with known or suspected hypersensitivity to the investigational product or its excipients;\n* Patients with severe malnutrition as judged by the investigator, or with a BMI \\\u003C 18.5 kg\u002Fm² at screening;\n* Patients with active malignancy or a history of malignancy; or with thyroid nodules classified as TI-RADS grade ≥ 4a on thyroid ultrasound; or with high-risk or suspected malignant nodules detected on chest CT; or with clinically significant abnormal tumor markers at screening;\n* For patients with a history of pituitary adenoma or other benign intracranial tumors:\n\n  1. Surgical resection of pituitary adenoma or other benign intracranial tumors within 12 months prior to screening;\n  2. Evidence of growth of pituitary adenoma or other benign intracranial tumors within 12 months prior to screening (must be confirmed by two postoperative MRI scans, with the most recent MRI scan performed ≤ 6 months before the screening period);\n* Patients with abnormal liver or renal function at screening (ALT \\> 3×ULN, Cr \\> 1.5×ULN);\n* Patients testing positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus antibody (anti-HIV) at screening;\n* Patients with a clinically significant change in body weight within 6 months prior to screening as judged by the investigator, or with a self-reported body weight change of ≥ 10% compared to 6 months before screening;\n* Patients with unstable control of diabetes mellitus within 3 months prior to screening (HbA1c ≥ 7.5% at screening), or with significant adjustment of hypoglycemic medication dose or change in therapeutic drug type, or with severe diabetic complications as judged by the investigator;\n* Patients with cardiac insufficiency classified as NYHA class ≥ III;\n* Patients with a history of acromegaly or gigantism;\n* Patients with mental disability or language impairment that prevents full participation in the trial;\n* Individuals who have participated in any clinical trial of investigational medicinal products (as a trial participant) and received investigational intervention within 3 months prior to screening;\n* Other conditions deemed unsuitable for enrollment by the investigator.","MALE","18 Years","80 Years",{"count":54,"type":22},36,[56],"PHASE2","This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose cohorts, and within each dose cohort, participants will be randomized in a 3:1 ratio.",[28],[60,61,62,63],"Inpegsomatropin Injection","Pharmacokinetic","Safety","Adults With Growth Hormone Deficiency","NOT_YET_RECRUITING","2026-05-22",{"date":67,"type":34},"2026-05-26",{"date":69,"type":22},"2026-05-31",{"date":71,"type":22},"2028-06-30",{"name":73,"class":74},"Xiamen Amoytop Biotech Co., Ltd.","INDUSTRY",6,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100466556","phase-2-growth-hormone-replacement-in-veterans-with-gwi-and-aghd-gwit-100466556","NCT05355272","Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)","Growth Hormone Replacement Therapy in Veterans With Gulf War Illness and Adult Growth Hormone Deficiency","GWIT","Inclusion Criteria:\n\n1. veteran of the Gulf War conflict with a history of deployment to Operation Desert Storm or Desert Shield between 1990-91\n2. age less than or equal to 64 years old\n3. have a diagnosis of Gulf War Illness assessed by study investigators\n4. have adult growth hormone deficiency diagnosed by glucagon stimulation test (cut point 3.0 mcg\u002FL if BMI is less than or equal to 25 or 1.0 mcg\u002FL if BMI is greater than 25)\n5. 4-week stability on any psychotropic medications\n6. 3-month stability on all hormone treatments\n7. able and willing to provide informed consent to participant in the study and complete study protocol\n\nExclusion Criteria:\n\n1. history of a psychiatric disorder with substantial impact on functional status or quality of life (e.g., schizophrenia, schizoaffective disorder, bipolar, or other psychotic disorder)\n2. history of neurologic disorder other than traumatic brain injury with substantial impact on the quality of life\n3. other known cause for growth hormone deficiency (GHD) including history of childhood onset GHD, hypothalamic\u002Fpituitary disease, history of brain radiation, or genetic mutations known to lead to GHD\n4. active suicidal ideation as determined by a score of 2 points or higher on the Columbia Suicide Severity Rating Scale\n5. suicidal behavior in the past 6 months\n6. contraindication to recombinant human growth hormone (rhGH) such as hypersensitivity to rhGH or any of the components of the supplied product\n7. acute medical illness, active infection, cancer, or decompensated chronic medical illness (e.g., decompensated diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease)\n8. evidence of substance use disorder in the past 6 months other than mild alcohol or cannabis use disorder diagnosed by clinician at time of screening.\n9. urine toxicology evidence of illicit drug use (excluding cannabis) within the past 90 days prior to screening\n10. BMI \\> 35 or body weight \\> 350 lbs\n11. abnormal pituitary anatomy documented by an MRI using a Sella protocol\n12. women who are pregnant or of child-bearing potential who are unable\u002Funwilling to use one of the following barrier contraceptives: condoms, diaphragm, cervical cap, or intrauterine device\n13. current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, hormonal contraceptives, progestin, insulin growth factor 1 (IGF-1), or chronic glucocorticoid use in supraphysiologic doses\n\n15\\) currently enrolled in any other interventional drug trials unless prior approval is provided by the study chairs and the study sponsor","64 Years",{"count":86,"type":22},20,[56],"The goal of the GWIT Study is to assess whether growth hormone replacement therapy is a safe and effective treatment for veterans with Gulf War Illness (GWI) and adult growth hormone deficiency (AGHD). The main questions the study aims to answer are:\n\n1. Is growth hormone effective at reducing fat in the trunk of the body and symptoms of GWI among veterans with GWI and growth hormone deficiency?\n2. Do the results of the study suggest there is merit in pursuing a larger trial to examine the efficacy of growth hormone as a treatment for growth hormone deficiency among veterans with Gulf War Illness?\n\nTo determine eligibility for the study, veterans will be asked to complete several assessments including questionnaires, blood tests, and a scan of the brain. Participants who qualify for the study will receive recombinant human growth hormone for 6-months. A body composition scan will be performed at Day1, Day 90, and Day 180 of the intervention. Questionnaires and cognitive tests will also be collected before and after the trial.",[90,28],"Gulf War Syndrome",[92,93],"recombinant human growth hormone","growth hormone replacement therapy","2026-05-05",{"date":96,"type":34},"2026-05-08",{"date":98,"type":34},"2024-03-11",{"date":100,"type":22},"2027-07-01",{"name":102,"class":103},"Baylor College of Medicine","OTHER",2,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":17,"minAge":51,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100594235","phase-1-a-clinical-study-of-gensci134-in-healthy-adults-and-adult-growth-hormone-deficiencyaghd-100594235","NCT07016802","A Clinical Study of GenSci134 in Healthy Adults and Adult Growth Hormone Deficiency(AGHD)","A Phase I, Randomized, Double-blind, Placebo and Active-controlled Study of Single and Multiple Ascending Doses of GenSci134 Injection in Healthy Adults, and a Single Ascending Dose in Patients With Adult Growth Hormone Deficiency","Inclusion Criteria:\n\nThe first part in Healthy adult volunteers:\n\n* Healthy adult male subjects（Phase Ia），or Healthy adult subjects（Phase Ib） aged 18-45 years (inclusive of boundary values);\n* Body Mass Index (BMI): 19.0-24.0 kg\u002Fm² (inclusive of boundary values);\n* Good health status;\n* Able to understand and willing to sign the Informed Consent Form (ICF), and comply with study requirements and restrictions.\n\nThe second part in AGHD patients（Phase Ic）:\n\n* Be able to understand and be willing to sign the written ICF (before any study procedure is performed).\n* Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests, and other specified study procedures.\n* Aged from 20 to 70 years old (inclusive), at the time of signing the ICF.\n* Body mass index (BMI): 18.0-32.0 kg\u002Fm² ((inclusive of boundary values).\n* Meeting any of the following diagnostic criteria for growth hormone deficiency:\n* Adult-onset: Participants with GHD due to hypothalamo-pituitary disorder or relevant treatments (surgery, radiotherapy) or other reasons (infection, traumatic craniocerebral injury, etc.); the participant has no relapse or residual disease is stable for more than 1 year after surgery for pituitary adenoma, surgery for craniopharyngioma or other pituitary gland operation.\n* Childhood-onset: Participants with childhood idiopathic, acquired, congenital GHD or childhood GHD for other reasons.\n* Confirmed diagnosis of AGHD (meeting at least one of the following criteria):\n* Insulin tolerance test: peak GH cut-off point ≤ 5 μg\u002FL.\n* Glucagon challenge test:\n* a) Participants with BMI \\\u003C 25 kg\u002Fm² or high clinical suspicion \\[≥ 3 pituitary hormone deficiencies (PHDs)\\] with BMI 25-30 kg\u002Fm², peak GH ≤ 3 μg\u002FL.\n* b) Participants with BMI \\> 30 kg\u002Fm² or low clinical suspicion (≤ 2 PHDs) with BMI 25-30 kg\u002Fm², peak GH ≤ 1 μg\u002FL.\n* ≥ 3 PHDs and IGF-1 SDS \\\u003C -2.0 at screening.\n* Participants who have not previously received human growth hormone (hGH) therapy or are in the washout period of previous hGH therapy.\n\nExclusion Criteria:\n\nThe first part in Healthy adult volunteers:\n\n* Subjects with significant medical history or clinical manifestations determined by the investigator;\n* History of hypersensitivity, intolerance, or allergy to any drug, compound, food, or other substances, or known allergy to any excipients of the study drug;\n* History of neurological or psychiatric disorders, or subjects with impaired consciousness or cognitive dysfunction;\n* Subjects with clinically significant abnormalities, including but not limited to vital signs or laboratory test results that are abnormal and clinically significant;\n* Subjects with immunodeficiency or immunosuppressive diseases at screening;\n* Subjects who have undergone major surgery within 12 months prior to screening;\n* Subjects with a history of neoplastic diseases;\n* Subjects who have participated in any other clinical trial of drugs or medical devices and have used the investigational medicinal product within 28 days or 5 half-lives (whichever is longer) before dosing.\n\nThe second part in AGHD patients（Phase Ic）:\n\n* Known or suspected hypersensitivity to the investigational medical product and\u002For any of its excipients.\n* Female participants who are pregnant, breast-feeding or intend to become pregnant or are of childbearing potential but not using an effective contraceptive method.\n* Male participants with fertility potential or their partners who do not use an effective contraceptive method.\n* Clinically significant hepatic disease.\n* Clinically significant chronic renal insufficiency.\n* Cardiac failure.\n* Use of any investigational product within 30 days prior to screening or participated in another trial within 30 days prior to dosing.\n* Use of systemic corticosteroids at non-alternative doses within 90 days prior to dosing.\n* Any disorder or treatment which, in the opinion of the investigator, possibly jeopardizes participant's safety or affects his\u002Fher compliance with the protocol.\n* History of diabetes mellitus.\n* History of malignancy or ongoing malignancy.\n* Active Cushing's syndrome within 24 months prior to dosing.\n* Acute severe diseases resulting in weight loss within 180 days prior to dosing.\n* Use of weight-reducing drugs known to affect body weight significantly within 12 months prior to dosing.\n* Presence of a mental or language disorder that impairs the ability to understand or cooperate with the study, unwillingness to participate, or any other condition that, in the opinion of the investigator or treating physician, renders the participant unsuitable for the trial.\n* Anticipated change in lifestyle during the trial.",true,"70 Years",{"count":115,"type":22},64,[117],"PHASE1","To check how safe and well-tolerated a single subcutaneous injection of GenSc134 is in healthy male volunteers， a multiple-doses subcutaneous injection of GenSc134 is in healthy volunteers，a single subcutaneous injection of GenSc134 is in AGHD patients.",[62,120,28],"Tolerability","2026-04-12",{"date":123,"type":34},"2026-04-14",{"date":125,"type":34},"2025-06-09",{"date":127,"type":22},"2026-11-25",{"name":129,"class":74},"Changchun GeneScience Pharmaceutical Co., Ltd.",1,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":130},"100569458","belux-children-outcome-during-adulthood-with-ghd-100569458","NCT06694506","BELux Children OutcoME During A(@)Dulthood With GHD","BELux Children OutcoME During A(@)Dulthood With Growth Hormone Deficiency","BELCOME@GHD","Inclusion Criteria:\n\n* Age \\> or = 18 years\n* Diagnosed with child-hood onset growth hormone deficiency (CO-GHD) (no exclusion criteria: isolated or multiple GHD, idiopathic or organic, severe or partial)\n* Registered in the BELGROW registry (informed consent at the time of inclusion in registry)\n* Stopped treatment with rhGH for growth after 2011\n* Persistent GHD at the end of growth\n\nExclusion Criteria:\n\n* No exclusion criteria",{"count":140,"type":22},200,[142],"NA","Our objective is to evaluate the outcome in adulthood of Belgian and Luxembourgish patients treated with rhGH during childhood for CO-GHD. The primary goal is to determine the proportion of adult CO-GHD patients who continue to receive regular medical follow-up and those still undergoing rhGH therapy using a questionnaire. Secondary objectives include assessing the regularity of follow-up and compliance with treatment in adulthood, evaluating possible comorbidities, health issues, lifestyle, living environment, and quality of life. Additionally, we aim to assess the metabolic profile in adulthood, particularly focusing on BMI, glycemic, and lipid data, for patients who consent to share their current clinical and biological data. Data will be described according to treatment adherence and CO-GHD etiology\u002Fphenotypes (e.g., idiopathic vs. organic GHD, isolated vs. combined GHD, partial vs. severe GHD).",[145,28],"Growth Hormone Deficiency",[147,148],"Growth Hormone","Adult","2024-11-15",{"date":151,"type":34},"2024-11-19",{"date":153,"type":22},"2024-12-15",{"date":155,"type":22},"2029-08-01",{"name":157,"class":103},"Cliniques universitaires Saint-Luc- Université Catholique de Louvain"]