[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07728383":3,"trial-entities:NCT07728383":108,"trial-summary:NCT07728383":111},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":47,"secondary_outcomes":52,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":15,"eligibility_criteria":69,"std_ages":77,"locations":80,"central_contacts":101,"overall_officials":102,"references":106,"see_also_links":107},"NCT07728383","GT-G-C-102","A Proof-of-Concept Study to Evaluate Topical-Lingual Semaglutide in Adults With Obesity","A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Topical-Lingual Semaglutide (T-L Semaglutide) in Adults With Obesity","RECRUITING","2027-05","2026-07","2026-07-27","2026-06-17","Gila Therapeutics, Inc.","INDUSTRY",false,"This study investigates the Topical-Lingual (T-L) delivery of semaglutide, a GLP-1 receptor agonist (GLP-1RA), via an oral liquid emulsion formulation as a Proof-of-Concept for the T-L delivery of metabolic hormones in general. GLP-1 is a gut-derived hormone that induces satiation through hypothalamic pathways.","This study investigates the Topical-Lingual (T-L) delivery of semaglutide, a GLP-1 receptor agonist (GLP-1RA), via an oral liquid emulsion formulation as a Proof-of-Concept for the T-L delivery of metabolic hormones in general. GLP-1 is a gut-derived hormone that induces satiation through hypothalamic pathways. This study will compare the efficacy (weight loss), safety and tolerability of oral versus topical-lingual semaglutide versus placebo. Pharmacokinetic data (semaglutide Cmax) will be compared across the 3 arms.",[19],"Obesity & Overweight",[21],"Obesity","INTERVENTIONAL","TREATMENT",[25],"PHASE4",{"count":27,"type":28},40,"ESTIMATED",[30,36,43],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Semaglutide 6 mg liquid emulsion formulation","Semaglutide 6 mg liquid emulsion formulation daily",[35],"Semaglutide liquid emulsion formulation",{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"Wegovy® (semaglutide) Tablet","Wegovy® (semaglutide) Tablet 25 mg daily",[40],"Wegovy Tablet",[42],"Wegovy® (semaglutide) Tablet 25 mg",{"type":31,"name":44,"description":45,"armGroupLabels":46},"Placebo liquid emulsion formulation","Placebo liquid emulsion formulation daily",[44],[48],{"measure":49,"description":50,"timeFrame":51},"Percent body weight change from baseline","Percentage change in body weight at 24 weeks from baseline by calibrated scale.","24 weeks",[53,56,60,63],{"measure":54,"description":55,"timeFrame":51},"Change in hemoglobin A1c","Percentage and absolute change in hemoglobin A1c from baseline to 24 weeks.",{"measure":57,"description":58,"timeFrame":59},"Comparison of plasma semaglutide levels (Cmax) in 3 arms of study","Maximum Plasma Concentration (Cmax) of semaglutide measured with verified analytic method across the 3 arms of the study","16 weeks",{"measure":61,"description":62,"timeFrame":51},"Proportion of subjects with 5% and 10% body weight loss","Proportion of subjects with 5% and 10% body weight loss at 24 weeks versus baseline on a calibrated scale",{"measure":64,"description":65,"timeFrame":51},"Nausea Severity Scale","NSS measures chronic nausea severity and ranges from 0 - 4 (mean of all 4 items). Higher scores mean a worse outcome.","ALL","18 Years","65 Years",{"inclusion":70,"exclusion":72,"raw_text":76},[71],"Body Mass Index 30 to 45",[73,74,75],"Type 2 Diabetes Mellitus","Multiple Endocrine Neoplasia Type 2","Medullary thyroid cancer","Inclusion Criteria:\n\n* Body Mass Index 30 to 45\n\nExclusion Criteria:\n\n* Type 2 Diabetes Mellitus\n* Multiple Endocrine Neoplasia Type 2\n* Medullary thyroid cancer",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":98},"Clinical Research Institute of Minnesota","Minneapolis","Minnesota","55402","United States",[88,93,96],{"name":89,"role":90,"phone":91,"email":92},"Gary D Berman, M.D.","CONTACT","612-333-2200","gdb@allergy-asthma-docs.com",{"name":94,"role":90,"phone":91,"email":95},"Kristin Weber, FNP-C","KW@allergy-asthma-docs.com",{"name":89,"role":97},"PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},44.97997,-93.26384,[],[103],{"name":104,"affiliation":13,"role":105},"Thomas Vasicek, Ph.D.","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":109,"biomarkers":110},[21],[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This is an interventional study comparing three different treatments: semaglutide liquid emulsion, Wegovy® tablets, and a placebo liquid emulsion. It plans to enroll 40 adult participants.","completed","Study of Topical-Lingual Semaglutide for Obesity","This study is looking at a new way to deliver semaglutide, a medicine often used for weight management. We are testing a liquid form of semaglutide that you would apply to your tongue, comparing it to the standard Wegovy® (semaglutide) Tablet and a placebo (an inactive substance). The main goal is to see how much body weight changes over 24 weeks. You might be able to join if you are an adult between 18 and 65 years old with a Body Mass Index (BMI) between 30 and 45. You cannot join if you have Type 2 Diabetes Mellitus, Multiple Endocrine Neoplasia Type 2, or Medullary thyroid cancer. This study is currently recruiting 40 participants.","The primary outcome of body weight change is measured at 24 weeks.",114,"Not specified in the trial record.","Not stated in the trial record.",[37],"v2"]