[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07081997":3,"trial-entities:NCT07081997":130,"trial-summary:NCT07081997":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":49,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":63,"locations":66,"central_contacts":117,"overall_officials":123,"references":128,"see_also_links":129},"NCT07081997","ASND0052","A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg\u002FDay in Adult Participants With Hypoparathyroidism","A Phase 3, Multicenter, Randomized, Open-Label Trial Investigating the Safety, Tolerability and Efficacy of Palopegteriparatide Administered Subcutaneously Daily at Doses Greater Than 30 μg\u002FDay in Adult Participants With Hypoparathyroidism","RECRUITING","2028-06","2026-08","2026-08-24","2026-05-07","Ascendis Pharma Bone Diseases A\u002FS","INDUSTRY",false,"This trial has a treatment duration of 78 weeks and will include adult participants already on treatment with palopegteriparatide at doses at or greater than 30 mcg\u002Fday. All participants will receive subcutaneous palopegteriparatide during the trial and will be individually and progressively titrated to an optimal dose at pre-specified dose levels. The primary purpose of the trial is to provide additional evidence of treatment effect and safety of palopegteriparatide at doses greater than 30 mcg\u002Fday in adults with hypoparathyroidism. The trial will be conducted in the US.",null,[19,20,21],"Hypoparathyroidism","Endocrine System Diseases","Parathyroid Diseases",[19,23,24,25,26,27,28,29],"Parathyroid Hormone","TransCon PTH","PTH(1-34)","Prodrug","Sustained Release","Parathyroid Hormone Replacement Therapy","Palopegteriparatide","INTERVENTIONAL","TREATMENT",[33],"PHASE3",{"count":35,"type":36},36,"ESTIMATED",[38,45],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"COMBINATION_PRODUCT","Palopegteriparatide Experimental Arm","Palopegteriparatide is administered as separate SC injection in a prefilled, single-patient use pen. Treatment duration 78 weeks.",[40],[44],"Yorvipath",{"type":39,"name":46,"description":41,"armGroupLabels":47,"otherNames":48},"Palopegteriparatide Control Arm",[46],[44],[50],{"measure":51,"description":52,"timeFrame":53},"Efficacy - Primary endpoint","The proportion of participants with:\n\nAlbumin-adjusted serum calcium (sCa) measured within 4 weeks prior to and on the Week 26 visit within the normal range (8.3-10.6 mg\u002FdL); and independence from active vitamin D; and independence from therapeutic doses of calcium; and no increase in prescribed investigational product within 4 weeks prior to Week 26 visit.","26 weeks",[],"ALL","18 Years",{"inclusion":58,"exclusion":61,"raw_text":62},[59,60],"Albumin-adjusted sCa 7.8 - 10.6 mg\u002FdL (or 1.95 - 2.64 mmol\u002FL)","Ionized sCa 4.40 - 5.29 mg\u002FdL (1.10 - 1.32 mmol\u002FL)",[],"Inclusion criteria:\n\n1. Males and females, ≥18 years of age at the time of providing informed consent\n2. Participants with postsurgical chronic hypoparathyroidism (HP), or auto-immune, genetic, or idiopathic HP, for at least 26 weeks\n3. Receiving doses of palopegteriparatide at or above 30 µg\u002Fday\n\n   For individuals receiving 30 µg\u002Fday: evidence that dose is insufficient to keep serum calcium in the normal range, defined as:\n\n   Documented hypocalcemia within 12 weeks prior to Screening; and\u002For Standing dose of calcitriol ≥0.25 μg\u002Fday, and \u002F or (elemental) calcium ≥1500 mg\u002Fday (e.g., calcium citrate, calcium carbonate etc.) for at least 4 weeks prior to Screening\n\n   For individuals receiving 33 µg\u002Fday or greater: no requirement for documented hypocalcemia or minimum doses of calcitriol or elemental calcium\n4. Confirmation of laboratory parameters (Central or Local) within 2 weeks of screening visit and prior to randomization:\n\n25(OH) vitamin D levels of ≥ 20 ng\u002FmL (≥49 nmol\u002FL) and Magnesium level in the normal range, or just below the normal range i.e.: ≥1.3 mg\u002FdL (≥0.53 mmol\u002FL) and Albumin-adjusted or ionized sCa level in the normal range or just below the normal range\n\n* Albumin-adjusted sCa 7.8 - 10.6 mg\u002FdL (or 1.95 - 2.64 mmol\u002FL)\n* Ionized sCa 4.40 - 5.29 mg\u002FdL (1.10 - 1.32 mmol\u002FL)\n\n  5\\. BMI 17- 40 kg\u002Fm2 at Screening\n\n  6\\. If ≤25 years of age, radiological evidence of epiphyseal closure based on locally interpreted X-ray of non-dominant wrist and hand\n\n  7\\. eGFR ≥30 mL\u002Fmin\u002F1.73 m2 during Screening using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\n\nExclusion criteria\n\n1. Impaired responsiveness to PTH (pseudohypoparathyroidism), which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia\n2. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HP\n3. Use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin \\>30 µg\u002Fday, or systemic corticosteroids (other than as replacement therapy)\n4. Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1\n5. Use of PTH-like drugs other than palopegteriparatide (whether commercially available or through participation in an investigational trial), including PTH(1-34), or other N-terminal fragments, analogs of PTH or PTH-related protein, or PTH1R biased agonists within 4 weeks prior to Screening\n6. Use of drugs known to influence calcium and bone metabolism within 12 weeks prior to Screening\n7. Use of denosumab or romosozumab within 2 years prior to Screening. Use of raloxifene within 4 weeks prior to Screening.\n8. Non-hypocalcemic seizure disorder with occurrence of a seizure within 26 weeks prior to Screening.\n9. Increased risk for osteosarcoma\n10. Women who are pregnant, intend to become pregnant, or are lactating\n11. Diagnosed drug or alcohol dependence within 3 years prior to Screening\n12. Chronic or severe cardiac disease within 26 weeks prior to Screening\n13. Cerebrovascular accident within 5 years prior to Screening.\n14. Within 26 weeks prior to Screening: acute colic due to nephrolithiasis, or acute gout\n15. Participation in any other interventional trial in which receipt of investigational drug or device other than palopegteriparatide occurred within 8 weeks (or within 5.5 times the half-life of the investigational drug) (whichever comes first) prior to Screening.\n16. Known allergy or sensitivity to PTH or any of the excipients \\[metacresol, mannitol, succinic acid, NaOH\u002F(HCl)\\] of the investigational product",[64,65],"ADULT","OLDER_ADULT",[67,76,83,90,96,103,110],{"facility":68,"status":8,"city":69,"state":70,"zip":71,"country":72,"geoPoint":73},"Ascendis Pharma Investigational Site","Chicago","Illinois","60637","United States",{"lat":74,"lon":75},41.85003,-87.65005,{"facility":68,"status":8,"city":77,"state":78,"zip":79,"country":72,"geoPoint":80},"Minneota","Minnesota","55905",{"lat":81,"lon":82},44.55885,-95.98559,{"facility":68,"status":8,"city":84,"state":85,"zip":86,"country":72,"geoPoint":87},"Reno","Nevada","89511",{"lat":88,"lon":89},39.52963,-119.8138,{"facility":68,"status":8,"city":91,"state":91,"zip":92,"country":72,"geoPoint":93},"New York","10032",{"lat":94,"lon":95},40.71427,-74.00597,{"facility":68,"status":8,"city":97,"state":98,"zip":99,"country":72,"geoPoint":100},"Greenville","North Carolina","27834",{"lat":101,"lon":102},35.61266,-77.36635,{"facility":68,"status":8,"city":104,"state":105,"zip":106,"country":72,"geoPoint":107},"Houston","Texas","77030",{"lat":108,"lon":109},29.76328,-95.36327,{"facility":68,"status":8,"city":111,"state":112,"zip":113,"country":72,"geoPoint":114},"Spokane Valley","Washington","99216",{"lat":115,"lon":116},47.67323,-117.23937,[118],{"name":119,"role":120,"phone":121,"email":122},"Ascendis Registry Inquiries","CONTACT","+4561161658","asnd_registryinquiries@ascendispharma.com",[124],{"name":125,"affiliation":126,"role":127},"Medical Director, MD","Ascendis Pharma A\u002FS","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":131,"biomarkers":132},[19],[],{"nct_id":4,"found":134,"summary":135,"prompt_version":145},true,{"design":136,"status":137,"heading":138,"summary":139,"follow_up":140,"word_count":141,"commitments":142,"compensation":143,"drugs_mentioned":144},"This is an interventional study with a planned enrollment of 36 adult participants. All participants will receive palopegteriparatide.","completed","Investigating Palopegteriparatide Doses for Hypoparathyroidism","This study is looking into the safety and effectiveness of higher doses of palopegteriparatide for adults with hypoparathyroidism (a condition where your body doesn't make enough parathyroid hormone). You might be able to join if you are 18 or older, have had hypoparathyroidism for at least 26 weeks, and are already taking palopegteriparatide at 30 micrograms per day or more. All participants will receive palopegteriparatide through injections under the skin, and your dose will be adjusted to find what works best for you. The main goal is to see how well palopegteriparatide works and if it's safe at these higher doses. The study's success will be measured after 26 weeks of treatment. The current recruitment status is unclear.","The primary effectiveness of the treatment will be measured at 26 weeks.",118,"You would participate in this trial for 78 weeks, receiving subcutaneous injections of palopegteriparatide with individualized dose adjustments.","Not stated in the trial record.",[],"v2"]