[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07699471":3,"trial-entities:NCT07699471":81,"trial-summary:NCT07699471":17},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":17,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":53,"locations":56,"central_contacts":73,"overall_officials":78,"references":79,"see_also_links":80},"NCT07699471","MBX-2H1005","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","RECRUITING","2029-08","2026-07","2026-07-13","2026-08","MBX Biosciences","INDUSTRY",true,"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).",null,[19],"Hypoparathyroidism",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},160,"ESTIMATED",[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Canvuparatide","• 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.",[31],[35],"MBX 2109",{"type":37,"name":38,"description":32,"armGroupLabels":39},"OTHER","Placebo",[38],[41],{"measure":42,"description":43,"timeFrame":44},"To evaluate the effect of pooled weekly doses of canvuparatide on the proportion of responder patients at week 26.","Responder status is defined as a study participant who meets the following composite criteria:\n\n* Independence from active vitamin D\n* Independence from therapeutic doses of calcium (standing elemental calcium dose of ≤ 600 mg\u002Fday)\n* 2 consecutive albumin-adjusted serum calcium results in the normal range (8.3-10.6 mg\u002FdL) (2.07-2.64 mmol\u002FL)\n* No increase in study drug","26 Weeks",[],"ALL","18 Years",false,{"inclusion":50,"exclusion":51,"raw_text":52},[],[],"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.",[54,55],"ADULT","OLDER_ADULT",[57,66],{"facility":58,"status":8,"city":59,"state":60,"zip":61,"country":62,"geoPoint":63},"MBX Biosciences Investigational Site","Homestead","Florida","33030","United States",{"lat":64,"lon":65},25.46872,-80.47756,{"facility":58,"status":8,"city":67,"state":68,"zip":69,"country":62,"geoPoint":70},"Shavano Park","Texas","78231",{"lat":71,"lon":72},29.58495,-98.55252,[74],{"name":75,"role":76,"phone":77},"Salomon Azoulay, MD","CONTACT","844-877-4473",[],[],[],{"nct_id":4,"conditions":82,"biomarkers":83},[19],[]]