[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypothalamic-obesity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypothalamic-obesity":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,79,111],{"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":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100574535","phase-3-a-trial-of-setmelanotide-in-patients-with-congenital-hypothalamic-obesity-sub-study-of-nct05774756-100574535",false,"NCT06760546","A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)","A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity","Key Inclusion Criteria:\n\n1. Diagnosis of multiple pituitary hormone deficiency (MPHD), or septo-optic dysplasia (SOD), or optic nerve hypoplasia (ONH), or Childhood-onset combined pituitary hormone deficiency (CPHD), or Pituitary Stalk Interruption Syndrome (PSIS) with at least one pituitary deficiency AND a body mass index (BMI) of ≥30 kg\u002Fm2 for patients ≥18 years of age, or BMI ≥95th percentile for age and sex for patients 4 to \\\u003C18 years\n2. Age 4 years and older\n3. Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg\u002Fm2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to \\\u003C18 years of age\n4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study\n\nKey Exclusion Criteria:\n\n1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)\n2. Weight loss \\>2% in the previous 3 months for patients aged ≥18 years or \\>2% reduction in BMI for patients aged 4 to \\\u003C18 years\n3. Bariatric surgery or procedure within last 2 years\n4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior\n5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease\n6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)\n7. History or close family history of skin cancer or melanoma\n8. Participation in any clinical trial with an investigational drug\u002Fdevice within 3 months prior to the first trial dose\n9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide\n10. Inability to comply with once daily (QD) injection regimen\n11. If female, pregnant and\u002For breastfeeding.\n12. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","4 Years",{"count":19,"type":20},39,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a sub-study of Study RM-493-040 (NCT05774756).\n\nThe goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.",[26,27,28,29,30,31],"Hypothalamic Obesity","Multiple Pituitary Hormone Deficiency Genetic Form","Septo-Optic Dysplasia","Optic Nerve Hypoplasia","Childhood-onset Combined Pituitary Hormone Deficiency","Pituitary Stalk Interruption Syndrome",[33],"melancortin 4 receptor, MC4R","RECRUITING","2026-02-10",{"date":37,"type":38},"2026-02-12","ACTUAL",{"date":40,"type":38},"2025-09-23",{"date":42,"type":20},"2028-03-13",{"name":44,"class":45},"Rhythm Pharmaceuticals, Inc.","INDUSTRY",11,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100534460","phase-1-a-study-of-rm-718-in-healthy-subjects-and-patients-with-mc4r-pathway-impairment-100534460","NCT06239116","A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment","A Study of RM-718 Weekly Formulation in Healthy Subjects With Obesity and in Patients With Obesity Due to MC4R Impairment","Key Inclusion Criteria:\n\nParts A and B:\n\n* Male and female subjects in good health aged 18-55 years of age at Screening.\n* Body mass index (BMI) ≥30 kg\u002Fm2.\n* Subjects who are medically healthy with normal or clinically insignificant screening results.\n* Subjects must use a highly effective form of contraception and follow the study contraception requirements.\n* Ability to communicate well with the Investigator, understand and comply with the requirements of the trial, and understand English and sign the written informed consent.\n\nPart C:\n\n* Male and female patients with HO, aged 12-65 years of age at Screening.\n* Patient has documented evidence of acquired HO defined as:\n\n  * Diagnosis of craniopharyngioma or other brain lesion affecting the hypothalamic region and has undergone surgery, or chemotherapy, or radiation therapy involving the hypothalamus at least 6 months before Screening, OR\n  * Documented injury to the hypothalamus at least 6 months before Screening for which surgery\u002Fradiation is not indicated.\n* Weight gain associated with the hypothalamic injury either before or following therapy (surgery and\u002For following chemotherapy or radiotherapy), and a BMI of ≥30 kg\u002Fm2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 12 to \\\u003C18 years of age.\n* Patients must use a highly effective form of contraception and follow the study contraception requirements.\n* Ability to communicate with the Investigator, understand and comply with the requirements of the trial, and understand and sign the written informed consent and assent (for patients aged \\\u003C18 years), and informed consent for a parent or guardian of any patient \\\u003C18.\n\nPart D:\n\n* Confirmed diagnosis of PWS as determined by the Investigator at the time of Screening.\n* Age ≥12 to 65, inclusive, at the time of signing Informed Consent and\u002For Assent.\n* BMI ≥30 kg\u002Fm2 for patients ≥18 years of age or BMI ≥95th Percentile for age and sex for patients \\\u003C18 years of age based on the US CDC criteria.\n* Able to meet contraception requirements.\n\nKey Exclusion Criteria:\n\nParts A and B\n\n* Any clinically significant abnormalities on screening laboratories or physical examination as determined by the Investigator.\n* Active or history of any significant medical condition such as and including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic or hematological disease.\n* Obesity due to genetic, syndromic, or endocrine etiologies.\n* History of renal transplant, end stage renal disease.\n* Diagnosis of severe psychiatric disorders.\n* Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and\u002For confound the results.\n* Cigarette smoking or dependence on caffeine, alcohol or drugs; unable or unwilling to abstain completely from caffeine, alcohol and related substances for 24 hours prior to and after study visits.\n* History of recent surgery (within 60 days of Screening).\n* Participation in any clinical trial with an investigational drug\u002Fdevice within 3 months or 5 half-lives, whichever is longer, prior to the first trial dose.\n* Pregnant and\u002For breastfeeding or desiring to become pregnant during this trial.\n\nPart C\n\n* Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET).\n* Weight loss \\>2% in the previous 3 months for patients aged ≥18 years or \\>2% reduction in BMI for patients aged 12 to \\\u003C18 years and\u002For anti-obesity medications for the treatment of obesity.\n* Bariatric surgery or procedure within the last 2 years.\n* Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior.\n* Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and\u002For confound the results.\n* History of renal transplant, end stage renal disease.\n* Participation in any clinical trial with an investigational drug\u002Fdevice within 3 months or 5 half-lives, whichever is longer, prior to the first trial dose, or previous participation in a trial with setmelanotide.\n* Pregnant and\u002For breastfeeding or desiring to become pregnant during this trial.\n* Obesity attributable to other genetic or syndromic conditions (eg, PPL \\[pro-opiomelanocortin (POMC), proprotein convertase subtilisin\u002Fkexin type 1 (PCSK1), leptin receptor (LEPR), collectively\\], Bardet-Biedl syndrome \\[BBS\\]) prior to the hypothalamic injury.\n\nPart D\n\n* Weight loss \\>2% in the previous 3 months for patients aged ≥18 years or \\>2% reduction in BMI for patients aged 12 to \\\u003C18 years or therapies for the treatment of obesity or hyperphagia.\n* Metabolic and bariatric surgery (MBS) or procedure within last 6 months.\n* Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior.\n* Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease considered severe enough to interfere with the trial and\u002For confound the results.\n* Pregnant and\u002For breastfeeding or desiring to become pregnant during this trial.\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",true,"12 Years","65 Years",{"count":58,"type":20},150,[60,61],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, and PK of RM-718 in healthy subjects with obesity and in patients with MC4R Pathway Impairment",[26,64,65],"Prader-Willi Syndrome","PWS",[67,68,69],"melanocortin 4 receptor (MC4R)","MC4R agonism","obesity","2025-12-18",{"date":72,"type":38},"2025-12-22",{"date":74,"type":38},"2024-03-05",{"date":76,"type":20},"2028-11-01",{"name":44,"class":45},7,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":110},"100585352","phase-4-tirzepatide-in-pws-ho-and-gnso-100585352","NCT06901245","Tirzepatide in PWS, HO and GNSO","The Effects of Tirzepatide in Young Adults With Prader-Willi Syndrome, Hypothalamic Obesity and General Non-Syndromic Obesity","Inclusion Criteria:\n\n* Individuals 18-26 years with a BMI in the obesity range (BMI ≥95th percentile for age and sex or ≥30 kg\u002Fm2) with either 1) genetically confirmed diagnosis of PWS, 2) hypothalamic obesity as defined by damage to the medial hypothalamic region resulting in dysregulation of satiety and energy balance as diagnosed by a physician, 3) general obesity unrelated to a genetic syndrome or underlying medical condition\n* In a stable care setting at least 6 months prior to enrollment\n* Able and willing to participate in study visits including tolerating blood draws, urine samples and tolerate DXA scan.\n* Ability to take weekly subcutaneous tirzepatide\n* Consistent caregiver if they are not independent\n* Stable diet and exercise regimen for at least 6 months prior to enrollment\n* Able to use contraceptive methods if able to conceive offspring in order to prevent unintentional pregnancy during the study\n\nExclusion Criteria:\n\n* Current or recent (within 3 months of start of study drug initiation) use of weight loss medications\n* Current use of insulin or sulfonylurea or other medication affecting insulin secretion or GLP1 clearance\n* Current or prior use of any GLP1A or DPP4 inhibitor during the 6 months before screening\n* Any medications that may affect the study endpoints\n* Significant weight change (\\>3% weight gain or loss) in the last 2 months prior to enrollment\n* Change in dose of chronic endocrine medications (testosterone, estrogen, levothyroxine, or growth hormone medications) \\>10%\u002Fkg\u002Fday for at least 3 months prior to study\n* Current pregnancy or desire to become pregnant within study period, current lactation\n* History of recurrent pancreatitis, CKD, gastroparesis\n* Chronic\u002Facute heart, kidney, or liver disease\n* Personal or family history of medullary thyroid carcinoma or MEN syndrome type 2\n* Uncontrolled diabetes (A1C \\>8.5%)\n* DVT\n* Cancer within the previous 5 years\n* Current participation in an interventional clinical study\n* Previous or planned surgical treatment for obesity\n* Individuals with current substance abuse equivalnt to moderate or severe based on DSM 5 criteria (Hasin DS, 2013)\n* Any suicidal ideation in the past year\n* Unable to perform any of the procedures for the study\n* Have a body weight, height, and\u002For width that that prohibits the ability to obtain accurate measurements according to the DXA manufacturer's specification\n* Any condition that would prevent successful participation in the study.","18 Years","26 Years",{"count":89,"type":20},36,[91],"PHASE4","This research study is comparing the effectiveness of a weight loss medication called Tirzepatide in young adults with Prader-Willi Syndrome and\u002For hypothalamic obesity, as compared to young adults with obesity that is unrelated to a genetic syndrome or underlying medical cause. These groups will be given medication for 1 year to see how weight and other health factors are effected by the medication.",[64,26,94],"Obesity\u002FTherapy",[96,97,98,64,26,99],"Tirzepatide","GLP1 Agonist","Obesity","General Obesity","2025-09-12",{"date":102,"type":38},"2025-09-16",{"date":104,"type":38},"2025-05-01",{"date":106,"type":20},"2026-12",{"name":108,"class":109},"Grace Kim","OTHER",3,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100539134","phase-2-efficacy-and-safety-of-phenterminetopiramate-in-youth-with-hypothalamic-obesity-100539134","NCT06299891","Efficacy and Safety of Phentermine\u002FTopiramate in Youth With Hypothalamic Obesity","Phentermine\u002FTopiramate in Children, Adolescents, and Young Adults With Hypothalamic Obesity: a Pilot and Feasibility Study","Inclusion Criteria:\n\n1. Males and Females; Ages 6-28 years (inclusive)\n2. History of rapid weight gain related to tumor onset or treatment, as assessed by an experienced endocrinologist (for example, change in BMI z-score \\> 0.2 and\u002For BMI +5% during the first 6 months following tumor treatment)\n3. Obesity (BMI \\> 95th%ile for age\u002Fsex using CDC 2000 reference for under 18; BMI \\> 30 kg\u002Fm2 for 18+ years)\n4. Recent evidence of hypothalamic injury by brain MRI with central review; \\>6 months status-post definitive therapy (surgery, chemotherapy, or radiation); no major operations\u002Fsurgeries planned during the study period.\n5. Stable on pituitary replacement\\* and\u002For appetite-modulating medications (including stimulants) for at least 2 months. \\*Adjustments of less than 25% (\\\u003C25%) are permitted to hydrocortisone, growth hormone or thyroid hormone. Sex steroids and DDAVP are exempt.\n6. Post-menarchal females must use a highly effective form of contraception, unless hypogonadotropic hypogonadism is documented. All participating females of child-bearing potential will have pregnancy testing as outlined in the protocol.\n7. Participants must be able to communicate well with the investigative team, must comply with requirements of the study, and be able to provide written informed consent and\u002For assent for individuals less than 18y with consent of a parent\u002Flegal guardian.\n\nExclusion Criteria:\n\n1. Contraindication to Phentermine, Topiramate, or Qsymia as assessed using current package inserts. Including: History of glaucoma and known hyperthyroidism.\n2. Known history of nephrolithiasis (kidney stones).\n3. Current clinical diagnosis of anorexia nervosa or bulimia nervosa in the medical record.\n4. Known history of metabolic acidosis, low bicarbonate on screening laboratory assessment (below lower limit of normal), or clinically significant bone disease requiring medication (beyond calcium and\u002For vitamin D).\n5. Current or recent (\\\u003C14 days) use of monoamine oxidase inhibitor.\n6. Known hypersensitivity to sympathomimetic amines.\n7. Clinically significant cardiovascular conditions, as defined as any of the following: i) abnormal blood pressure, defined as: under 13y, 95th%ile +12 mm Hg or \\> 140\u002F90, whichever is lower; 13y and older, \\> 140\u002F90 ; ii) history of cardiac arrhythmia or arrhythmia detected on screening ECG; iii) history of heart failure and\u002For cardiomyopathy; iv) prolonged QTc interval (QTc \\> 460 msec), and\u002For long QT syndrome phenotype and\u002For positive genotype for long QT syndrome pathogenic; v) history of cardiac disease including coronary artery disease.\n8. Females who are pregnant, breastfeeding, or planning to become pregnant during the trial.\n9. \"Brittle\" diabetes insipidus (in the opinion of the referring endocrinologist, e.g. requiring frequent hospitalizations and\u002For frequent abnormal sodium values).\n10. Diabetes mellitus requiring insulin\u002Fsecretagogue. HbA1c \\> 8.5% at Screening.\n11. Clinically significant hyperthyroidism as assessed using thyroid hormone measurements. Clinical measurements within 12 months of baseline\u002Fscreening may be used to assess this criterion.\n12. History of clinically significant hypokalemia (low potassium) or current clinically significant hypokalemia (low potassium) on baseline\u002Fscreening labs.\n13. Clinically significant liver disease and\u002For known severe hepatic impairment. ALT \\> 3 x Upper Limit of Normal (ULN) AST \\> 3 x ULN\n14. Clinically significant kidney disease. GFR\\\u003C60 ml\u002Fmin\u002F1.73m2\n15. History of seizure in the 12 months prior to Screening.\n16. History of substance abuse, depression of moderate or greater severity, psychiatric disorder and\u002For suicidality.\n17. History of abdominal surgery including gastric bypass.\n18. Current use of supra-physiologic steroids.\n19. History of allergy or sensitivity to test agents. Including individuals with known aspirin allergy or hypersensitivity and\u002For known allergy to FD\\&C Yellow No. 5 (tartrazine).\n20. Concurrent use of carbonic anhydrase inhibitors.\n21. Concurrent use of non-potassium sparing diuretics.\n22. New weight management medication (or \\>5% decrease in weight over prior 2 months on any current, stable regimen), stimulant, and\u002For investigational medication within 2 months prior to screening, and\u002For plans to initiate other new weight management regimen.\n23. Cognitive impairment that, in the opinion of the investigator, precludes participation in the study.\n24. Individuals considered, in the Investigator's opinion, not suitable to participate in the study for reasons other than those indicated above.","6 Years","28 Years",{"count":121,"type":20},24,[61],"Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine\u002Ftopiramate (Ph\u002FT) that is FDA-approved for \"common\" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph\u002FT-induced decrease in appetite and increase in alertness.\n\nPreliminary assessments of safety, adverse events, dosing (Aim 1), as well as of efficacy (% BMI loss, Aim 2) will be made in a 28-week parallel-arm double-blinded Phase 2 placebo-controlled clinical trial in 6-28-year-old individuals with HO.",[26,125,126],"Hypothalamic Tumor","Craniopharyngioma",[128,129,26,130],"Hypothalamic Lesion","Drug Intervention","Phentermine\u002FTopiramate","2025-07-23",{"date":133,"type":38},"2025-07-28",{"date":135,"type":38},"2025-03-01",{"date":137,"type":20},"2026-05-31",{"name":139,"class":109},"Seattle Children's Hospital",2]