[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lumos Pharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":126},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,80,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100588961","phase-3-phase-3-study-of-lum-201-in-children-with-growth-hormone-deficiency-100588961",false,"NCT06948214","Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency","A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)","Inclusion Criteria:\n\n* Subjects must be naïve to treatment and prepubertal\n* Subjects must have a maximal GH response of \\\u003C 10 ng\u002FmL from 2 prior GH stimulation tests conducted within the preceding 12 months\n* Impaired height defined as ≥ 2.0 standard deviations (SDs) below the mean height for chronological age and sex\n* Morning or random cortisol level of ≥ 7.0 μg\u002FdL\n* ≥ 3.0 years and age ≤ 10.0 years for girls and ≤ 11.0 years for boys\n* Baseline height velocity (HV) based on ≥ 6 months of growth assessments \\\u003C 25th percentile for age and sex\n* Bone Age delay of ≥ 12 months compared to the chronological age\n* In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative.\n* Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 3 months prior to Day 1\n* Baseline IGF-1 standard deviation score (SDS) ≤ -1.0\n\nExclusion Criteria:\n\n* Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and\u002For limit the response to exogenous growth factor treatment.\n* Arm span to height ratio \\> 2 SDs below the mean for age and sex\n* A medical or genetic condition that, in the opinion of the Investigator and\u002For MM, adds unwarranted risk to use of LUM-201\n* Use of any medication that, in the opinion of the Investigator and\u002For MM, can independently cause short stature or limit the response to exogenous growth factors\n* Current inflammatory diseases requiring systemic corticosteroid treatment for \\> 2 consecutive weeks within the last 3 months prior to the Screening Visit\n* Use of hormone replacement therapy for any hormone deficiency other than thyroid deficiency\n* Any ECG at the Screening Visit noted to have a clinically significant abnormality, as confirmed by the MM\n* Any subjects suspected of having past or present intracranial tumor growth as confirmed by brain imaging prior to the Screening or Day 1 Visit\n* Any subject suspected of having intracranial hypertension (IH) as confirmed by fundoscopy and other assessments\n* Any subject with serum alanine transaminase (ALT), aspartate transaminase (AST), or total bilirubin \\> upper limit of normal (ULN)\n* Suspicion of absent pituitary function as evidenced by a maximal stimulated GH ≤ 3.0 ng\u002FmL on any prior standard of care GH stimulation test completed within 12 months\n* Body weight ≤ 14.0 kg\n* BMI \\\u003C -2 or \\> +2 SDs for age and sex based on WHO standards\n* Birth weight for gestational age \\\u003C 3rd percentile based on WHO standards\n* Treatment with medications known to be moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A\u002F4\n* History of spinal, cranial, or total body irradiation\n* Attention deficit hyperactivity disorder (ADHD) diagnosis","ALL","3 Years","11 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The OraGrowtH Phase 3 Trial is a multi-national trial. The goals of the trial are to study LUM-201 as a treatment for Pediatric Growth Hormone Deficiency (PGHD) in naive to treatment children and validate the LUM-201 predictive enrichment marker (LUM-201 PEM) strategy to select subjects likely to respond to therapy with daily oral LUM-201.",[27],"Growth Hormone Deficiency (GHD)",[29,30,31,32,33,34,35,36,37,38,39,40,41],"GHD","Pediatric Growth Hormone Deficiency","LUM-201","Growth hormone secretagogue","Height","Catch-up growth","PEM","Oral","Predictive Enrichment Marker","ibutamoren mesylate","OraGrowtH Phase 3 Trial","LUM-201 PEM","GH secretagogue","RECRUITING","2026-08-20",{"date":45,"type":46},"2026-08-21","ACTUAL",{"date":48,"type":46},"2026-05-20",{"date":50,"type":21},"2028-01",{"name":52,"class":53},"Lumos Pharma","INDUSTRY",47,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100650923","evaluating-the-efficacy-and-safety-of-lum-201-plus-semaglutide-versus-semaglutide-plus-placebo-in-older-obese-adults-100650923","NCT07754045","Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults","Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of Oral LUM-201 as an Adjunct to Oral Semaglutide for Improving Physical Function in Older Adults With Obesity","Inclusion Criteria:\n\n* Be willing to provide written informed consent to participate in this study.\n* Males or females, aged ≥ 60 to \\\u003C 85 years.\n* Have a BMI ≥ 30 kg\u002Fm2.\n* SPPB score at the screening visit ≥ 7 to ≤ 9.\n* Have a history of ≥ 1 self-reported unsuccessful dietary effort to lose weight.\n* Female participants must be postmenopausal, confirmed by an follicle stimulating hormone (FSH) level ≥ 25 IU\u002FL.\n* Male participants must be able to comply with contraception requirements.\n* Must agree to refrain from any reconstructive and\u002For cosmetic surgery and\u002For non-invasive cosmetic procedure that may affect body weight during the study such as mammoplasty, lipoplasty, non-invasive adipose and\u002For cellulite treatment devices.\n* Must refrain from scheduling any elective surgery and\u002For other invasive or non-invasive procedures during the study unless medically warranted.\n\nExclusion Criteria:\n\n* Have Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM).\n* Have laboratory evidence diagnostic of diabetes mellitus during screening.\n* Have history of diabetic ketoacidosis or hyperosmolar state\u002Fcoma within 6 months prior to screening.\n* Have a history of severe hypoglycemia.\n* Have a BMI \\> 45 kg\u002Fm2 or weight \\> 159 kg (350 lbs.).\n* Have a self-reported change in body weight \\> 5 kg (11 lbs.) within 3 months prior to screening.\n* Have received prior exposure to a GLP-1 receptor agonist (including dual GLP-1\u002F GIP receptor agonists\\]) within 180 days before screening, any other anti-obesity medication, glucose-lowering agent (non-GLP-1), or glucose lowering supplements such as berberine, etc. within 90 days before screening.\n* Have any other condition not listed in this section (for example, hypersensitivity or intolerance) that is a contraindication to GLP-1 receptor agonist or dual GLP-1\u002FGIP receptor agonist.\n* Have serum calcitonin concentration \\> 35 pg\u002FmL at screening.\n* Have a history of prior or planned surgical treatment for obesity.\n* Have uncontrolled hypertension with systolic blood pressure (SBP) ≥ 150 mm Hg and\u002For diastolic blood pressure (DBP) ≥ 95 mm Hg.\n* Mean QTcF (Fridericia \\[QTcF=QT\u002FRR1\u002F3\\]) interval \\> 450 ms (male) or \\> 470 ms (female) on triplicate ECGs.\n* Have fasting triglyceride \\> 500 mg\u002FdL.\n* Have any of the following within last 6 months prior to screening: NYHA Functional Classification I-IV heart failure, myocardial infarction, angina, coronary artery bypass graft, percutaneous coronary intervention, transient ischemic attack, stroke, or decompensated congestive heart failure.\n* Have an estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m2.\n* Have a known clinically significant gastric emptying abnormality.\n* Have a history of chronic or acute pancreatitis, or severe gastroesophageal reflux disease and symptomatic cholelithiasis with intact gallbladder.\n* Have serum lipase and\u002For amylase above 1.5 × the upper limit of normal (ULN).\n* Have a history of hepatic disorders including cirrhosis or other hepatic disorder other than metabolic-associated fatty liver disease (MAFLD), or nonalcoholic fatty liver disease.\n* Have active hepatitis B or C virus at screening. Have known positive history of human immunodeficiency virus. Have an active Coronavirus Disease 2019 at screening.\n* Have an impaired liver function, defined as screening aspartate aminotransferase (AST) \\> 2.5 × ULN, or alanine aminotransferase \\> 2.5 × ULN, or total bilirubin level \\> 1.2 × ULN (except for cases of known Gilbert's Syndrome).\n* Alkaline phosphatase (ALP) level \\> 1.5 × ULN.\n* Have untreated or uncontrolled hypothyroidism or hyperthyroidism.\n* Have obesity induced by other endocrinologic disorders.\n* Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years.\n* Have any lifetime history of a suicide attempt.\n* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within the past 5 years prior to screening.\n* Have had a transplanted organ (corneal transplants \\[keratoplasty\\] allowed) or awaiting an organ transplant.\n* Have any hematological condition that may interfere with HbA1c measurement (for example, hemolytic anemias, sickle cell disease).\n* Are receiving or have received within 3 months prior to screening chronic (\\> 2 weeks or 14 days) systemic glucocorticoid therapy or have evidence of a significant active autoimmune abnormality that has required treatment within the last 3 months.\n* Have current or recent treatment with medications and\u002For supplements that may cause significant weight gain.\n* Currently receiving or planning to initiate during the study any muscle toning or body contouring treatments such as high-intensity focused electromagnetic therapy, or neurotoxin injections targeting large muscle groups (for example, trapezius, gastrocnemius) for slimming or relaxation purposes.\n* Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) or alternative remedies intended to promote weight loss.\n* Have started implantable or injectable contraceptives (such as Depo-Provera®) within 6 months prior to screening.\n* Documented moderate to severe obstructive sleep apnea (unless controlled by medically prescribed intervention for at least 3 months prior to screening).\n* Prior treatment with growth factors including, but not limited to, GH, IGF-1, and GH secretagogues.","60 Years","84 Years",{"count":65,"type":21},202,[67],"PHASE2","This is a phase 2 randomized, double-blind, placebo-controlled, multi-center study evaluating the efficacy and safety of LUM-201 plus Semaglutide versus Semaglutide plus placebo in obese adults with body mass index between 30 and 45 kg\u002Fm\\^2, between the ages of 60 and 85 years that have mild functional impairment.",[70],"Obesity & Overweight","NOT_YET_RECRUITING","2026-08-06",{"date":74,"type":46},"2026-08-10",{"date":76,"type":21},"2027-02-15",{"date":78,"type":21},"2028-02-15",{"name":52,"class":53},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100649141","phase-1-trial-of-nlg802-indoximod-prodrug-plus-temozolomide-for-patients-with-progressive-pediatric-brain-cancer-100649141","NCT07732413","Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer","Phase 1b Trial of NLG802 Indoximod Prodrug Plus Temozolomide for Patients With Progressive Pediatric Brain Cancer","Inclusion Criteria:\n\n* Age must be ≥ 5 years and \\\u003C 22 years.\n* Subjects must have relapsed or treatment-refractory primary brain or spinal malignancy of any histology.\n* Subjects are allowed to have surgical debulking and\u002For radiation\u002Fproton therapy prior to enrollment in this trial.\n* Tumor tissue is required for central review of tissue diagnosis and biomarker correlate studies.\n* Collection of baseline blood samples for required biomarker correlate trials.\n* Performance score: Lansky or Karnofsky performance status score must be ≥ 70.\n* Life expectancy must be ≥ 3 months.\n* Hemoglobin ≥ 10 g\u002FdL\n* Platelets ≥ 100,000\u002FμL\n* ANC ≥ 1,000\u002FμL\n* ALT ≤ 3-times upper limit of normal.\n* Total bilirubin ≤ 1.5-times upper limit of normal.\n* Adequate renal function\n* Seizure disorders must be well controlled with antiepileptic medication.\n* Subjects must be able to swallow pills.\n* Corticosteroid therapy: When necessary for adrenal replacement, subjects may receive hydrocortisone ≤ 1.7 mg\u002Fkg\u002Fday, maximum dose 70 mg\u002Fday (or equivalent).\n* At the time of starting protocol therapy, subjects must be ≥ 21 days from the administration of any prior cytotoxic therapy (including chemotherapy).\n* At the time of starting protocol therapy, subjects must be ≥ 28 days from any radiation or proton therapy.\n* At the time of starting protocol therapy, subjects must be ≥ 28 days from administration of antibody-based immune checkpoint-inhibitor therapies, tumor-directed vaccines, or cellular immune therapies.\n* At the time of starting protocol therapy, subjects must be ≥ 56 days from administration of tumor-directed therapies using infectious agents.\n* At the time of starting protocol therapy, subjects must be ≥ 90 days from a stem cell transplant with growth-factor independent recovery of adequate bone marrow function.\n* Subjects, or their parent for subjects \\\u003C 18 years of age, must sign an Informed Consent Form (ICF) indicating that they understand the purpose of the trial and procedures required, including biomarkers, and are willing to participate in the trial.\n\nExclusion Criteria:\n\n* Unable to swallow capsules.\n* Active therapy for radiation necrosis.\n* Baseline QTcB of \\> 470 msec at screening, and subjects with known congenital long QT syndrome.\n* Clinically significant cardiovascular disease.\n* Active systemic infection requiring treatment.\n* Active autoimmune disease that requires systemic therapy.\n* Any known bleeding diathesis.\n* Subjects who are breastfeeding or pregnant women.","5 Years","21 Years",{"count":90,"type":21},30,[92],"PHASE1","This is a open label Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme, in combination with temozolomide chemotherapy in children with primary brain tumors.",[95],"Progressive Pediatric Brain Cancer","2026-07-23",{"date":98,"type":46},"2026-07-28",{"date":100,"type":21},"2026-10-08",{"date":102,"type":21},"2030-10-08",{"name":52,"class":53},1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100602918","phase-3-phase-3-long-term-safety-extension-study-of-lum-201-in-children-with-growth-hormone-deficiency-100602918","NCT07129759","Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency","A Long-term Extension Study to Evaluate the Safety and Tolerability of Daily Oral LUM-201 in Children With Growth Hormone Deficiency (GHD)","Inclusion Criteria:\n\n* Parent\u002Fcaregiver must be willing to provide written informed consent, and the subject must sign the assent, as applicable.\n* Subject must have successfully completed 12 months of participation in the LUM-201 Phase 3 GHD trial, and be eligible for continuation of treatment, pending all other enrollment criteria are met.\n* Subject who is sexually active must use an acceptable form of contraception.\n* Subject must be eligible for the Day 1 visit as confirmed by the Investigator.\n\nExclusion Criteria:\n\n* Subject has a medical or genetic condition that, in the opinion of the Investigator and\u002For MMs, adds unwarranted risk to use of LUM-201.\n* Pregnancy.\n* Subject has planned or is receiving current long-term treatment with medications known to prolong the QT interval or act as substrates, inducers, or inhibitors of the cytochrome system cytochrome P450 type 3A4 that metabolizes LUM-201 (see Appendix 6 for list of example medications). Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the Investigator in consultation with the MMs.","4 Years","12 Years",{"count":20,"type":21},[24],"This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.",[27],"2026-07-06",{"date":120,"type":46},"2026-07-08",{"date":122,"type":21},"2027-02",{"date":124,"type":21},"2030-02",{"name":52,"class":53},""]