[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07156578":3,"trial-entities:NCT07156578":147,"trial-summary:NCT07156578":150},{"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":35,"secondary_outcomes":39,"sex":55,"minimum_age":56,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":65,"locations":69,"central_contacts":140,"overall_officials":141,"references":145,"see_also_links":146},"NCT07156578","RM-MC72-002","A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)","A Long-Term, Open-Label Extension Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)","ENROLLING_BY_INVITATION","2028-04-15","2026-02","2026-02-10","2025-11-10","Rhythm Pharmaceuticals, Inc.","INDUSTRY",false,"This is a long-term, open-label extension study of bivamelagon in participants with Hypothalamic Obesity (HO) who have transitioned from the index study, LG-MCCL005. The study will last up to 2 years.",null,[19],"Hypothalamic Obesity",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},25,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Bivamelagon","daily dose of oral bivamelagon",[34],"Bivamelagon (open-label)",[36],{"measure":37,"timeFrame":38},"Safety and tolerability of bivamelagon as assessed by the number and frequency of AEs","Baseline to up to 2 years",[40,42,44,46,48,50,52],{"measure":41,"timeFrame":38},"Mean change and mean percentage change from Baseline in BMI in participants ≥18 years of age.",{"measure":43,"timeFrame":38},"Mean change in BMI z-score in participants >18 years of age.",{"measure":45,"timeFrame":38},"Mean change in and mean percentage change in weight",{"measure":47,"timeFrame":38},"Mean change in percentage of the 95th percentile of BMI in participants \u003C18 years of age.",{"measure":49,"timeFrame":38},"Percentage of patients who achieve ≥5%,≥10%, ≥15%, and ≥20% reduction in BMI from baseline",{"measure":51,"timeFrame":38},"Mean change from Baseline in Physical function (and total score) for the Impact of Weight on Quality of Life-Lite (IWQoL) in participants ≥18 years of age",{"measure":53,"timeFrame":54},"Change from Baseline in total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides","Baseline to up 2 years","ALL","12 Years",{"inclusion":58,"exclusion":61,"raw_text":64},[59,60],"Completed LG-MCCL005 and participant demonstrated adequate safety and tolerability in that study as determined by the Investigator.","Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after.",[62,63],"Willing to remain off of: CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates for the duration of the study.","In the opinion of the Investigator, participant is not suitable to participate in the study.","Key Inclusion Criteria:\n\n* Completed LG-MCCL005 and participant demonstrated adequate safety and tolerability in that study as determined by the Investigator.\n* Agree to use a highly effective form of contraception and follow contraception requirements throughout the study and for 90 days after.\n\nKey Exclusion Criteria:\n\n* Willing to remain off of: CYP3A4 inhibitors, strong CYP3A4 inducers, and P-glycoprotein inhibitors or substrates for the duration of the study.\n* In the opinion of the Investigator, participant is not suitable to participate in the study.\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",[66,67,68],"CHILD","ADULT","OLDER_ADULT",[70,79,87,95,102,110,118,126,133],{"facility":71,"city":72,"state":73,"zip":74,"country":75,"geoPoint":76},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",{"lat":77,"lon":78},39.72943,-104.83192,{"facility":80,"city":81,"state":82,"zip":83,"country":75,"geoPoint":84},"University of Iowa Children's Hospital","Iowa City","Iowa","52242",{"lat":85,"lon":86},41.66113,-91.53017,{"facility":88,"city":89,"state":90,"zip":91,"country":75,"geoPoint":92},"Tufts Medical Center","Boston","Massachusetts","02111",{"lat":93,"lon":94},42.35843,-71.05977,{"facility":96,"city":97,"state":97,"zip":98,"country":75,"geoPoint":99},"Columbia University","New York","10027",{"lat":100,"lon":101},40.71427,-74.00597,{"facility":103,"city":104,"state":105,"zip":106,"country":75,"geoPoint":107},"The University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27514",{"lat":108,"lon":109},35.9132,-79.05584,{"facility":111,"city":112,"state":113,"zip":114,"country":75,"geoPoint":115},"St. Jude Children's Research Hospital","Memphis","Tennessee","38105",{"lat":116,"lon":117},35.14953,-90.04898,{"facility":119,"city":120,"zip":121,"country":122,"geoPoint":123},"Birmingham Women's and Children's NHS Foundation Trust","Birmingham","B15 2TG","United Kingdom",{"lat":124,"lon":125},52.48142,-1.89983,{"facility":127,"city":128,"zip":129,"country":122,"geoPoint":130},"University of Cambridge","Cambridge","CB2 1TN",{"lat":131,"lon":132},52.2,0.11667,{"facility":134,"city":135,"zip":136,"country":122,"geoPoint":137},"Great Ormond Street Hospital for Children","London","WC1N 3JH",{"lat":138,"lon":139},51.50853,-0.12574,[],[142],{"name":143,"affiliation":13,"role":144},"David Meeker, MD","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":148,"biomarkers":149},[19],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]