[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ascendis Pharma A\u002FS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":154},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,63,87,112,134],{"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":31,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100609997","phase-3-trial-investigating-the-efficacy-and-safety-of-weekly-lonapegsomatropin-compared-to-daily-somatropin-in-children-and-adolescents-with-short-stature-or-growth-failure-due-to-growth-hormone-sufficient-disorders-100609997",false,"NCT07221851","Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders","A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature","Inclusion Criteria:\n\n1. Chronological age between ≥2 and \\\u003C18 years, at start of screening.\n2. Naïve to growth hormone and growth hormone promoting therapies.\n3. Prepubertal.\n4. Able to stand without assistance.\n5. Diagnosis of TS, SHOX-D, SGA, or ISS with impaired growth or short stature, according to the following disease-specific criteria:\n\n   TS or SHOX-D (Léri-Weill dyschondrosteosis):\n   1. Diagnosis confirmed by a genetic test. NOTE: Historical test results are acceptable for proof of diagnosis. For karyotypes, a minimum of 20 cells must be counted.\n   2. Impaired growth or short stature defined as:\n\n   (i.) AHV \\\u003C25th percentile over a time span of 6-16 months prior to screening utilizing a historical height properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \\\u003C5th percentile for sex and age according to the Centers for Disease Control Growth Charts for the United States\n\n   SGA without catch-up growth:\n\n   c. Birth weight and\u002For birth length \\\u003C -2.0 SDS for gestational age according to the 2006 World Health Organization Child Growth Standards. For infants born premature, the Fenton Preterm Infant Growth Chart (Fenton 2013) should be used.\n\n   d. Impaired growth or short stature defined as: (i.) AHV \\\u003C25th percentile over a time span of 6-16 months prior to screening properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \\\u003C -2.0 SDS for age and sex according to the 2000 Centers for Disease Control Growth Charts for the United States for children ≥ 3 years or height \\\u003C -2.5 SDS for age and sex according to the for children ≥ 2 years and \\\u003C 3 years\n\n   ISS:\n\n   e. Height \\\u003C -2.25 SDS for sex and age according to the Centers for Disease Control Growth Charts for the United States with no identifiable cause for short stature.\n\n   f. Documented normal GH-IGF-1 axis, defined as either: (i.)IGF-1 SDS \\>0 at screening based on central laboratory OR (ii.)Historical documentation of normal peak GH upon stimulation test (as defined by local institution) g. 46,XX chromosome as determined by karyotype or microarray if female. For karyotypes, a minimum of 30 cells must be counted.\n6. If on hormone replacement therapies for any hormone deficiencies other than growth hormone (e.g., adrenal, thyroid), must be on adequate and stable doses for ≥4 weeks prior to and throughout screening.\n7. Written, signed informed consent provided by parent(s) or legal guardian(s) of the participant. Assent should be signed by participant as required by IRB\u002FHREC\u002FIEC.\n\nExclusion Criteria:\n\n1. Advanced bone age X-ray by central reading defined as \\>20% above chronological age in months (Greulich 1959).\n2. Closed epiphyses as defined as bone age of ≥14.0 years in females or ≥16.0 years in males.\n3. Current clinical diagnosis of diabetic retinopathy\n4. Any diagnosis or presence at screening of the following:\n\n   1. Untreated moderate or severe sleep apnea as determined by formal (local) read of an inpatient or at-home sleep study.\n   2. Prader Willi syndrome with severe obesity, history of severe upper airway obstruction, or severe respiratory impairment.\n5. Signs\u002Fsymptoms of intracranial hypertension, active proliferative retinopathy.\n6. Uncontrolled hypo- or hyperthyroidism.\n7. Uncontrolled diabetes mellitus (defined as: HbA1c \\>7.5% from central laboratory at screening).\n8. Known history or diagnosis of any gastrointestinal inflammatory condition, HIV, radiation exposure, other skeletal dysplasias, growth hormone deficiency, and\u002For cardio-thoracic surgery due to their independent effects on growth.\n9. Any significant hepatic or renal abnormality, such as abnormal renal function (defined as eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2).\n10. Undiagnosed or uncontrolled hypertension.\n11. Receiving treatment with any agent that might influence growth or interfere with GH secretion or action including any sex steroids and stimulants for attention-deficit\u002Fhyperactivity disorder (ADHD).\n12. High dose inhaled glucocorticoid for more than 28 consecutive days total over the course of 12 months.\n13. Female who is pregnant, plans to be pregnant, or breastfeeding.\n14. Participation in another interventional clinical trial involving an investigational compound within 90 days prior to screening or in parallel to this trial.\n15. Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures.\n16. Exclusion Criteria only applicable to TS:\n\n    1. Presence of Y chromosome material on genetic testing without history of gonadectomy.\n    2. Less than 10% of 45,X mosaicism.\n    3. Any known, clinically significant, congenital or acquired cardiovascular dysfunction that might interfere with growth.\n17. Exclusion Criteria only applicable to SGA:\n\n    a. Any known clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements: (i.)Chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of GH receptors.\n\n    (ii.)Congenital abnormalities (causing skeletal abnormalities), including but not limited to skeletal dysplasias.\n18. Exclusion Criteria only applicable to ISS:\n\n    1. Known history of any condition that causes disproportionate short stature (i.e. skeletal dysplasias), chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of gH receptors.","ALL","2 Years","17 Years",{"count":20,"type":21},186,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \\\u003C18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.",[27,28,29,30],"Turner Syndrome","Short Stature Homeobox Gene Mutation","Idiopathic Short Stature","Small for Gestational Age at Delivery",[27,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,28,49,29],"Noonan Syndrome","Growth Hormone","Short Stature","Growth Failure","Sex Chromosome Disorders","Chromosome Disorders","Endocrine System Diseases","Pituitary Hormones, Anterior","Pituitary Hormones","Hormones","Hormone Substitutes","Human Growth Hormone","Lonapegsomatropin","Sex Chromosome Disorders of Sex Development","Impaired Growth","somatropin","Growth Hormone Sufficiency","Short Stature Children Born Small for Gestational Age","RECRUITING","2026-06-19",{"date":53,"type":54},"2026-06-23","ACTUAL",{"date":56,"type":54},"2025-12-12",{"date":58,"type":21},"2029-03",{"name":60,"class":61},"Ascendis Pharma A\u002FS","INDUSTRY",25,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":5},"100572409","phase-2-a-clinical-trial-to-evaluate-efficacy-and-safety-of-navepegritide-in-adolescents-12---18-years-of-age-with-achondroplasia-100572409","NCT06732895","A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia.","A Phase 2b, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial Evaluating Efficacy and Safety of Subcutaneous Doses of Navepegritide Administered Once Weekly for 52 Weeks in Adolescents (12-18 Years of Age) With Achondroplasia.","teACH","Inclusion Criteria:\n\n* Written, signed informed consent and\u002For assent of the participant, participant parent(s) or legal guardian(s) of the participant, and as required by the institutional review board\u002Fhuman research ethics committee\u002Findependent ethics committee (IRB\u002FHREC\u002FIEC). For participants who are below the age of consent, a written assent will be obtained in accordance with applicable requirements as required by IRB\u002FHREC\u002FIEC. Upon reaching the legal age of consent, depending on applicable requirements, these participants will be asked to give their own written consent.\n* Male or female, between 12 (inclusive) and 18 years of age at the time of randomization\n* Clinical diagnosis of ACH with documented genetic confirmation available. Documentation of historic test results are acceptable for proof of diagnosis.\n* Parent(s)\u002Flegal guardian(s) willing and able to administer weekly SC injections of IMP and to follow the protocol.\n* At least one historical standing height measurement available from medical records. The measurement must have been collected between 6 months to 15 months prior to the time of screening.\n\nExclusion Criteria:\n\n* Participation (signed informed consent) in any interventional clinical trial within 3 months prior to Screening unless no doses of IMP was given.\n* Decreased growth velocity (AGV less than 1.5 cm\u002Fyear based on measurement over a period of at least 6 months) or radiological evidence of growth plate closure.\n* Known or suspected hypersensitivity to the IMP or related products (trehalose, tris\\[hydroxymethyl\\]aminomethane, succinate, and mPEG).\n* Have a growth disorder or medical condition other than ACH that results in short stature, or abnormal growth such as SADDAN, hypochondroplasia, growth hormone deficiency, Turner syndrome, pseudo-ACH, inflammatory bowel disease, celiac disease, hypothyroidism, hyperthyroidism, or diabetes mellitus.\n* Severe mutation in the FGFR3 gene, e.g. two variants on the same allele or severe ACH with developmental delay and acanthosis nigricans, are not eligible for trial participation.\n* Have received any dose of prescription medications and\u002For IMP (placebo treatment only is allowed, if documented) or surgical intervention intended to affect stature, growth, or body proportionality at any time.\n* Requires, or anticipated to require, chronic (more than 4 weeks) or repeated treatment (more than twice\u002Fyear and less than 3 weeks\u002Fyear) with systemic corticosteroids during participation in the trial. Chronic use of high dose inhaled corticosteroids is not allowed.\n* Known history of presence of injury or disease of the growth plate(s), other than ACH, that affects growth potential of long bones.\n* Known history of any bone-related surgery affecting growth potential of long bones, such as:\n\n  * Orthopedic reconstructive surgery for bone lengthening (e.g., procedures for leg bowing such as 8-plate are not exclusionary).\n  * Ventriculoperitoneal (VP) shunt and laminectomy with full recovery are allowed with minimum of 6 months of bone healing.\n  * Bone fracture within 6 months prior to screening (within 2 months for fracture of digits and buckle fractures).\n* Clinically significant findings at Screening, such as:\n\n  * Expected to require surgical intervention during participation in the trial that may significantly affect trial parameters (confounding of safety events) or would prevent the participant from performing trial procedures. Common surgeries, such as insertion of grommets, adenoidectomy, tonsillectomy, or myringotomy tube placement, are permitted.\n  * Severe untreated sleep apnea or newly initiated sleep apnea treatment (e.g., Continuous Positive Airway Pressure \\[CPAP\\] in the previous 2 months prior to Screening.\n  * MS disease, such as Salter-Harris fractures or clinical and\u002For radiographic evidence of severe hip pathology\n  * Otherwise, are considered by the Investigator to be unfit to receive trial treatment or undergo trial related procedures.\n* Have a clinically significant finding or arrhythmia as determined by the investigator in consultation with the medical monitor that indicates abnormal cardiac function or conduction that includes, but is not exclusive to:\n\n  * Repaired or unrepaired coarctation.\n  * Moderate or greater complexity congenital heart disease including tetralogy of Fallot, Atrioventricular septal defects, truncus arteriosus, total anomalous pulmonary venous return, double outlet right ventricle, or single ventricle heart disease.\n* QT corrected using Fridericia's correction (QTcF) ≥ 450 msec at Screening.\n* Known history or presence of condition that impacts hemodynamic stability (such as autonomic dysfunction and orthostatic intolerance).\n* Known history or presence of the following:\n\n  * Chronic anemia (iron deficiency anemia that is resolved or adequately treated in the Investigator's opinion is allowed).\n  * Chronic renal insufficiency defined as estimated glomerular filtration rate (eGFR) according to the revised bedside Schwartz equation less than 60 mL\u002Fmin\u002F1.73 m2 for more than 3 months.\n  * Chronic or recurrent illness that can affect hydration or volume status, including conditions associated with decreased nutritional intake or increased volume loss.\n* Known history or presence of malignant disease.\n* Participant with serum 25-hydroxy-vitamin D (25OHD) levels of less than 30 nmol\u002FL (less than 12 ng\u002FmL) at Screening Visit will be excluded. Participants with 25OHD levels between 30-50 nmol\u002FL (12-20 ng\u002FmL) can be randomized provided treatment with Vitamin D supplementation is initiated according to local standards.\n* Any disease or condition that, in the opinion of the Investigator, may make the participant unlikely to fully complete the trial, may confound interpretation of trial results, or may present undue risk from receiving trial treatment. This could include family situations, complications or manifestations, or medications that might impact safety or be considered confounding.\n* Sexually active male and female participants and female partners of male participants of childbearing potential not using a highly effective form of contraceptive for the entire trial period and for 90 days after last dose of trial treatment.\n* Female participants who are pregnant, lactating or breastfeeding.","12 Years",{"count":73,"type":21},24,[75],"PHASE2","The purpose of this clinical trial is to evaluate efficacy and safety of once weekly subcutaneous (SC) doses of navepegritide 100 μg\u002Fkg compared to placebo (inactive drug) in adolescents aged 12 to 18 years with Achondroplasia. What will be measured is Annualized Growth Velocity after a 52-week treatment period.",[78],"Achondroplasia","2026-04-20",{"date":81,"type":54},"2026-04-21",{"date":83,"type":54},"2024-12-10",{"date":85,"type":21},"2027-09",{"name":60,"class":61},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":98,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100613288","a-study-to-assess-the-amount-of-palopegteriparatide-in-breast-milk-of-lactating-females-requiring-yorvipath-palopegteriparatide-100613288","NCT07264634","A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)","Inclusion Criteria:\n\n* 1\\. Lactating female participants 18 years of age or older treated with YORVIPATH as part of their usual medical care and who have chosen to breastfeed. Note: The participant must have been taking YORVIPATH for a minimum of 14 days prior to sample collection.\n* 2\\. The major source of infant nutrition must be breast milk (Note: Only one supplemental bottle of no more than up to 8 oz of formula per day will be allowed during the 14 days before start of the study).\n* 3\\. Daily dose of YORVIPATH administered within the last 14 days has been stable.\n* 4\\. Participants recruited from other sources must enroll in the Pregnancy Registry before being allowed to participate in the Lactation Study.\n* 5\\. Written consent or eConsent obtained.\n\nExclusion Criteria:\n\n* 1\\. Presence of any medical condition that, in the opinion of the investigator, may impair the ability to breastfeed during this study, including but not limited to mastitis and nipple malformation","FEMALE","18 Years","50 Years",{"count":97,"type":21},10,"6 Days","OBSERVATIONAL","This is an observational, opportunistic lactation study to be conducted in lactating female participants who are currently receiving therapeutic doses of YORVIPATH as part of their usual care and who have chosen to breastfeed their infant(s). The potential transfer of palopegteriparatide into breast milk will be assessed.",[102],"Hypoparathyroidism","2026-04-15",{"date":105,"type":54},"2026-04-17",{"date":107,"type":54},"2026-03-19",{"date":109,"type":21},"2028-01",{"name":60,"class":61},1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":119,"maxAge":17,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100522190","phase-2-a-clinical-trial-to-evaluate-efficacy-and-safety-of-transcon-cnp-compared-with-placebo-in-infants-0-to-2-years-of-age-with-achondroplasia-100522190","NCT06079398","A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to \u003C2 Years of Age) With Achondroplasia","A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-controlled Trial, Evaluating Safety, Tolerability, and Efficacy of Subcutaneous Doses of TransCon CNP Administered Once Weekly for 52 Weeks in Infants (0 to \u003C2 Years of Age) With Achondroplasia Followed by an Open Label Extension (OLE) Period","Inclusion Criteria:\n\n* Written, signed informed consent by the parent(s)\u002Fcaregiver(s) of the participant, and as required by the institutional review board\u002Fhuman research ethics committee\u002Findependent ethics committee (IRB\u002FHREC\u002FIEC).\n* Male or female younger than 2 years of age at the time of randomization; or for open label sentinel participants, at the time of first administration of IMP.\n* Clinical diagnosis of achondroplasia (ACH) with genetic confirmation of heterozygous genotype present during screening.\n* Parent(s)\u002Fcaregiver(s) willing to follow the protocol and instructions provided, including being able to administer weekly subcutaneous injections of trial treatment.\n* Compliance to daily Vitamin D supplementation for infants aged 14 days to 1 year. All participants older than 1 year of age with serum 25-hydroxyvitamin D (25OHD) measured below lower limit of reference range at screening should start daily Vitamin D supplementation prior to randomization.\n* Considered eligible based on the medical history, physical examination, and the results of vital signs, ECG, imaging, and clinical laboratory tests performed during the screening period.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to the investigational product or related products (trehalose, tris\\[hydroxymethyl\\]aminomethane, succinate, and polyethylene glycol \\[PEG\\]).\n* Genetic confirmation of ACH homozygous genotype.\n* Premature birth with gestational age \\\u003C 32 weeks.\n* Premature birth with gestational age 32 to 37 weeks, unless time from birth is \\> 6 months at the time of screening and the child is in good nutritional status, defined as gain in body weight expected for age and diagnosis of ACH, as determined by the Investigator and confirmed with the Medical Monitor.\n* Anticipated, as assessed by Investigator and confirmed with Medical Monitor, to undergo surgical intervention during trial participation, including cervicomedullary decompression. Evaluation of immediate risk of requiring cervicomedullary decompression surgery will rely on the following assessments:\n\n  * Physical examination (e.g., neurologic findings of clonus, opisthotonus, exaggerated reflexes, dilated facial veins)\n  * Evidence of uncontrolled sleep apnea as confirmed by local standard of care assessment (e.g. polysomnography or simple sleep test) performed within 6 months prior to screening.\n  * MRI performed at screening indicating presence of severe cervicomedullary compression (CMC) or spinal cord damage. Presence of abnormal MRI T2 signal intensity at and immediately above and below the cervicomedullary junction should be considered high risk for requiring surgery and the participant is not eligible for trial participation.\n\nCommon surgeries, such as insertion of grommets, adenoidectomy, tonsillectomy, or myringotomy tube placement are permitted during trial participation.\n\n* Have a growth disorder or medical condition, other than ACH, resulting in short stature or abnormal growth as determined by the Investigator and confirmed with the Medical Monitor.\n* Have received any dose of prescription medications and\u002For investigational medicinal product or device intended to affect stature, growth, or body proportionality (including human growth hormone or vosoritide) at any time.\n* Requires or anticipated to require chronic (\\> 4 weeks) or repeated treatment (more than twice\u002Fyear) with oral corticosteroids, or high-dose inhaled corticosteroids during trial participation.\n* History or presence of injury or disease of the growth plate(s), other than ACH, affecting growth potential of long bones, including Salter-Harris fracture and recent bone-related surgery, as determined by Investigator and confirmed with the Medical Monitor.\n* Have a clinically significant finding indicating abnormal cardiac function, including but not limited to:\n\n  * Repaired or unrepaired coarctation.\n  * Moderate or greater complexity congenital heart disease including tetralogy of Fallot, atrioventricular septal defects, truncus arteriosus, total anomalous pulmonary venous return, double outlet right ventricle, or single ventricle heart disease.\n  * QTcF ≥ 450 msec on screening 12-lead ECG.\n* History or presence of a condition impacting hemodynamic stability (such as autonomic dysfunction and orthostatic intolerance).\n* History or presence of the following:\n\n  * Chronic anemia.\n  * Chronic renal insufficiency.\n  * Chronic or recurrent illness that can affect hydration or volume status, including conditions associated with decreased nutritional intake or increased volume loss.\n* History or presence of malignant disease.\n* Any disease or condition that, in the opinion of the Investigator, may make the participant unlikely to fully complete the trial, not adhering to trial procedures, may confound interpretation of trial results, or may present undue risk from receiving trial treatment. This could include family situations, comorbid conditions, or medications that might impact safety or be considered confounding.","0 Years",{"count":121,"type":21},72,[75],"This trial is a Phase 2, multicenter, double-blind, randomized (ratio 2:1 TransCon CNP vs. placebo), placebo-controlled trial, designed to evaluate the safety, tolerability, and efficacy of 100 μg CNP\u002Fkg of Navepegritide (TransCon CNP) administered SC once-weekly for 52 weeks in infants with genetically verified heterozygous ACH, aged 0 to \\\u003C 2 years at the time of randomization.",[78],"2026-04-07",{"date":127,"type":54},"2026-04-08",{"date":129,"type":54},"2024-01-23",{"date":131,"type":21},"2028-12",{"name":60,"class":61},18,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":93,"minAge":140,"maxAge":95,"enrollmentInfo":141,"targetDuration":143,"studyType":99,"phases":4,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":111},"100619505","a-global-pregnancy-registry-to-assess-maternal-fetal-and-infant-outcomes-following-exposure-to-yorvipath-palopegteriparatide-during-pregnancy-and-breastfeeding-100619505","NCT07345494","A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding","Inclusion Criteria:\n\n* Participants aged 15 to 50 years\n* Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception and\u002For during pregnancy. The timeframe of 15 days prior to conception is calculated based on 5 times the YORVIPATH half life of \\~ 60 hours\n* Participants providing written informed consent, verbal consent, or eConsent (depending on country regulations) and a Medical Release of Information. For adolescents under the age of majority, verbal or written informed assent by the pregnant minor (where applicable) and verbal or written informed consent by the parent\u002Flegal guardian will be obtained.\n\nExclusion Criteria:\n\n* Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.","15 Years",{"count":142,"type":21},50,"21 Months","The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the first year of life.",[102],"2026-02-26",{"date":148,"type":54},"2026-03-02",{"date":150,"type":54},"2026-02-18",{"date":152,"type":21},"2036-01",{"name":60,"class":61},""]