[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07733947":3,"trial-entities:NCT07733947":87,"trial-summary:NCT07733947":90},{"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":44,"sex":54,"minimum_age":55,"maximum_age":15,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":61,"locations":64,"central_contacts":74,"overall_officials":81,"references":85,"see_also_links":86},"NCT07733947","CBL-0303 (Stage 1)","A Study to Evaluate the Maintenance of Efficacy and Long-term Safety of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)","A Phase 3b, Multicenter, Two Stage, Double-blind, Long Term Follow up and Open Label Extension Study of Participants Who Have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)","NOT_YET_RECRUITING","2028-09","2026-07","2026-07-30","2026-12","Caliway Biopharmaceuticals Co., Ltd.","INDUSTRY",null,"A Phase 3b, Multicenter, Two stage, Double-blind, Long term Follow up and Open-label Extension Study of Participants Who have Completed the CBL-0301 or CBL-0302 Study for Reducing Abdominal Subcutaneous Fat (Stage 1)","A total of approximately 300 adult participants that has received at least one study drug treatment and completed one follow-up visit in the parent studies will be enrolled. Each participant will undergo three follow-up visits, scheduled every three months in Stage 1.",[19],"Subcutaneous Fat",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},300,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","CBL-514 Injection","Provided as a ready for use injectable CBL-514 solution",[34],"CBL-514 injection",{"type":30,"name":36,"description":37,"armGroupLabels":38},"0.9 % sodium chloride","Injectable 0.9% Sodium Chloride solution as placebo",[39],"Injectable 0.9% Sodium Chloride solution",[41],{"measure":42,"timeFrame":43},"Percentage of participants with at least 1 TEAE","6,9, and 12 months after last treatment of parent studies",[45,47,51],{"measure":46,"timeFrame":43},"Percentage of participants with at least 1 AESI",{"measure":48,"description":49,"timeFrame":50},"Percentage of participants who maintain at least a 1-grade improvement on both Participant Reported Abdominal Fat Rating Scale (PR-AFRS) and Clinician Reported Abdominal Fat Rating Scale (CR-AFRS)","Measured by 5-point ordinal scales from Grade 1 to Grade 5 for assessing the severity of abdominal fat. The higher the grade, the more the abdominal fat.","From baseline to 6,9, and 12 months after last treatment in parent studies",{"measure":52,"description":53,"timeFrame":50},"Percentage change from baseline in abdominal fat","Measured by MRI","ALL","18 Years",false,{"inclusion":58,"exclusion":59,"raw_text":60},[],[],"Inclusion Criteria:\n\n1. Participant must have received at least 1 treatment of CBL 514 or Placebo and completed the FU1 visit of the parent study.\n2. Participant is willing to maintain a stable lifestyle.\n3. Participant voluntarily signs the Informed Consent Form (ICF) for Stage 1 and, in the opinion of the Investigator or delegate, is physically and mentally capable of participating in the study, and willing to adhere to the study procedures.\n\nExclusion Criteria:\n\n1. Participant has had or will be undergoing treatment that may affect the evaluation of the treated area.\n2. Participant is taking prescription or over the counter (OTC) weight reduction medication or is in a weight reduction program.\n3. Participant has an unstable condition or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.\n4. Female participant of childbearing potential who is not willing to commit to an acceptable contraceptive method or who is currently pregnant or lactating. Male participant who is not committed to using condoms consistently throughout the study. Ova and sperm donation are to occur after a certain washout period post IP treatment.",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"Investigational site 1","Encinitas","California","92024","United States",{"lat":72,"lon":73},33.03699,-117.29198,[75],{"name":76,"role":77,"phone":78,"phoneExt":79,"email":80},"NT Tan","CONTACT","+886-2-26971355","1319","CR@caliwaybiopharma.com",[82],{"name":83,"affiliation":13,"role":84},"Anne Sheu","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":88,"biomarkers":89},[19],[],{"nct_id":4,"found":91,"summary":92,"prompt_version":102},true,{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is a Phase 3b, double-blind (meaning neither you nor your doctor will know if you received CBL-514 or placebo), long-term follow-up and open-label extension study involving about 300 participants.","completed","CBL-514 for Long-Term Fat Reduction","This study is looking at the long-term effects of CBL-514 Injection for reducing subcutaneous fat (fat under the skin). It's also comparing CBL-514 to a placebo (0.9% sodium chloride, a salt water solution). You may be able to join if you've already received CBL-514 or placebo in a previous study and completed a follow-up visit. The main goal is to see how many participants experience side effects over 6, 9, and 12 months after their last treatment in the earlier studies. The study aims to enroll about 300 adults, but its current status is unclear.","Participants will be followed for 6, 9, and 12 months after their last treatment in the parent studies to check for side effects.",95,"You would have three follow-up visits, scheduled every three months, after completing a previous study.","Not stated in the trial record.",[31],"v2"]