[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054159":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":36,"responsibleParty":60,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":30,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":30,"enrollmentInfo":71,"targetDuration":30,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":30,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"MBX Biosciences","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Canvuparatide","ACTIVE_COMPARATOR","Canvuparatide is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of canvuparatide via a manual SC injection. Dosing is once weekly.",[13],"Drug: Canvuparatide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo is provided as an integral drug-device combination product (DDC) intended for single-use administration, to deliver 1mL of placebo via a manual SC injection. Dosing is once weekly.",[19],"Other: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","• Drug per vial: Each DDC contains 1 vial of lyophilized drug product. The reconstituted strengths are 400 μg\u002FmL, 600 μg\u002FmL, 800 μg\u002FmL, 1000 μg\u002FmL, 1200 μg\u002FmL, 1400 μg\u002FmL, and 1600 μg\u002FmL.",[9],[26],"MBX 2109",{"type":28,"name":15,"description":23,"armGroupLabels":29,"otherNames":30},"OTHER",[15],null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":30},"Salomon Azoulay, MD","CONTACT","844-877-4473",[37,51],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":30},"MBX Biosciences Investigational Site","RECRUITING","Homestead","Florida","33030","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-80.47756,25.46872,{"lat":49,"lon":48},{"facility":38,"status":39,"city":52,"state":53,"zip":54,"country":43,"countryCode":44,"cosmosGeoPoint":55,"geoPoint":59,"contacts":30},"Shavano Park","Texas","78231",{"type":46,"coordinates":56},[57,58],-98.55252,29.58495,{"lat":58,"lon":57},{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100054159","phase-3-a-study-to-investigate-canvuparatide-compared-with-placebo-in-adult-patients-with-hypoparathyroidism-100054159",false,"NCT07699471","A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Followed by an Open-Label Extension to Evaluate the Safety and Efficacy of Canvuparatide (MBX 2109) in Adult Patients With Hypoparathyroidism","Key Inclusion Criteria:\n\n1. Is an adult ≥18 years of age.\n2. Has a documented diagnosis of post-surgical, chronic HypoPT or genetic, idiopathic, or autoimmune HypoPT for at least 12 months prior to screening.\n3. Intact PTH level below the median value of the normal range\n4. Minimum requirement for a dose of calcitriol ≥0.5 μg\u002Fday, or alfacalcidol ≥1.0 μg\u002Fday and (elemental) calcium ≥1000 mg\u002Fday for at least 12 weeks prior to screening. In addition, the doses of calcitriol, or alfacalcidol, and calcium should be stable for at least 3 weeks prior to screening.\n5. Two (2) consecutive measurements of albumin-adjusted serum calcium at least 1 week apart within the range of 7.8 to 9.4 mg\u002FdL (1.95 to 2.35 mmol\u002FL).\n\nKey Exclusion Criteria:\n\n1. Has a known history of pseudohypoparathyroidism\n2. Clinically significant abnormal hematology, clinical chemistry, or coagulation.\n3. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HypoPT, such as active endogenous hyperthyroidism;\n4. Use of therapies affecting the calcium metabolism within 4 weeks prior to randomization\n5. PTH or PTH-related protein drugs such as PTH(1-84) and PTH(1-34) within 5 weeks prior to screening.","ALL","18 Years",{"count":72,"type":73},160,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","The purpose of this study is to investigate the efficacy and safety of canvuparatide administered as a once-weekly (QW) treatment to adult study participants with hypoparathyroidism (HypoPT).",[79],"Hypoparathyroidism","2026-07-07",{"date":82,"type":83},"2026-07-13","ACTUAL",{"date":85,"type":73},"2026-08",{"date":87,"type":73},"2029-08",{"name":5,"class":6},2]