[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07446439":3,"trial-entities:NCT07446439":176,"trial-summary:NCT07446439":180},{"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":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":47,"secondary_outcomes":52,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":72,"locations":75,"central_contacts":167,"overall_officials":170,"references":174,"see_also_links":175},"NCT07446439","VP-VLY-686-3601","A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use","The Thetis Study: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tradipitant on Nausea and Vomiting After GLP-1R Agonist Administration in Healthy Overweight or Obese Volunteers","RECRUITING","2026-12-01","2026-02","2026-04-20","2026-03-27","Vanda Pharmaceuticals","INDUSTRY",true,"The goal of this study is to measure the effects of using Tradipitant to treat nausea and vomiting induced by GLP-1R agonist use in adults with class I or class II obesity, or adults who are overweight with at least one weight-related condition. The study is placebo-controlled with two treatment arms.",null,[19,20],"Nausea and Vomiting","Obesity",[22,23,24,25],"GLP-1R agonist","Semaglutide","Nausea","Vomiting","INTERVENTIONAL","TREATMENT",[29],"PHASE3",{"count":31,"type":32},280,"ESTIMATED",[34,43],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":40},"DRUG","Tradipitant","Oral Capsule",[39],"Tradipitant Group",[41,42],"Nereus","VLY-686",{"type":35,"name":44,"description":37,"armGroupLabels":45},"Placebo",[46],"Placebo Group",[48],{"measure":49,"description":50,"timeFrame":51},"Proportion of participants with at least 1 vomiting episode per week in the tradipitant group compared to the placebo group as measured by a daily symptom diary.","A questionnaire called the Nausea Vomiting Daily Diary (NV-DD) will be completed once a day, which will be used to collect data for this endpoint. The NV-DD asks participants to record their vomiting frequency in a 24-hour period.","1 week",[53,56],{"measure":54,"description":55,"timeFrame":51},"Proportion of participants with worst nausea severity score ≥ 3 and at least one vomiting episode over 1 week.","Nausea and vomiting symptoms will be assessed using the NV-DD. The NV-DD asks participants to rate their nausea symptoms on a Likert scale from 0-5 (0=none, 5= very severe) as well as their vomiting frequency in a 24-hour period.",{"measure":57,"description":58,"timeFrame":51},"To evaluate the effect of tradipitant relative to placebo on the worst of 7 daily nausea severity scores over 1 week.","Nausea symptoms will be assessed using the NV-DD. The NV-DD asks participants to rate their nausea symptoms on a Likert scale from 0-5 (0=none, 5= very severe).","ALL","18 Years","65 Years",{"inclusion":63,"exclusion":66,"raw_text":71},[64,65],"Body Mass Index ≥ 25 and \\\u003C 40 kg\u002Fm\\^2","No serious medical problems or chronic diseases, specifically no type I or type II diabetes",[67,68,69,70],"Another disorder that contributes to gastrointestinal symptoms","History of intolerance and\u002For hypersensitivity to NK-1 receptor antagonists","History of intolerance and\u002For hypersensitivity to GLP-1 receptor agonists","Exposure to any investigational medication within the past 60 days","Inclusion Criteria:\n\n* Body Mass Index ≥ 25 and \\\u003C 40 kg\u002Fm\\^2\n* No serious medical problems or chronic diseases, specifically no type I or type II diabetes\n\nExclusion Criteria:\n\n* Another disorder that contributes to gastrointestinal symptoms\n* History of intolerance and\u002For hypersensitivity to NK-1 receptor antagonists\n* History of intolerance and\u002For hypersensitivity to GLP-1 receptor agonists\n* Exposure to any investigational medication within the past 60 days",[73,74],"ADULT","OLDER_ADULT",[76,89,97,107,116,125,133,141,150,158],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":86},"Vanda Investigational Site","Los Angeles","California","90025","United States",[83],{"name":13,"role":84,"phone":85},"CONTACT","202-734-3400",{"lat":87,"lon":88},34.05223,-118.24368,{"facility":77,"status":8,"city":90,"state":79,"zip":91,"country":81,"contacts":92,"geoPoint":94},"San Diego","92108",[93],{"name":13,"role":84,"phone":85},{"lat":95,"lon":96},32.71571,-117.16472,{"facility":77,"status":98,"city":99,"state":79,"zip":100,"country":81,"contacts":101,"geoPoint":104},"NOT_YET_RECRUITING","San Jose","95124",[102],{"name":13,"role":84,"phone":103},"(202) 734-3400",{"lat":105,"lon":106},37.33939,-121.89496,{"facility":77,"status":8,"city":108,"state":109,"zip":110,"country":81,"contacts":111,"geoPoint":113},"Tampa","Florida","33613",[112],{"name":13,"role":84,"phone":103},{"lat":114,"lon":115},27.94752,-82.45843,{"facility":77,"status":98,"city":117,"state":118,"zip":119,"country":81,"contacts":120,"geoPoint":122},"Hamilton","New Jersey","08690",[121],{"name":13,"role":84,"phone":103},{"lat":123,"lon":124},40.20706,-74.08125,{"facility":77,"status":98,"city":126,"state":126,"zip":127,"country":81,"contacts":128,"geoPoint":130},"New York","10016",[129],{"name":13,"role":84,"phone":85},{"lat":131,"lon":132},40.71427,-74.00597,{"facility":77,"status":98,"city":134,"state":126,"zip":135,"country":81,"contacts":136,"geoPoint":138},"Syosset","11791",[137],{"name":13,"role":84,"phone":103},{"lat":139,"lon":140},40.82621,-73.50207,{"facility":77,"status":98,"city":142,"state":143,"zip":144,"country":81,"contacts":145,"geoPoint":147},"Plano","Texas","75024",[146],{"name":13,"role":84,"phone":103},{"lat":148,"lon":149},33.01984,-96.69889,{"facility":77,"status":98,"city":151,"state":143,"zip":152,"country":81,"contacts":153,"geoPoint":155},"San Antonio","78215",[154],{"name":13,"role":84,"phone":103},{"lat":156,"lon":157},29.42412,-98.49363,{"facility":77,"status":98,"city":159,"state":160,"zip":161,"country":81,"contacts":162,"geoPoint":164},"Burke","Virginia","22015",[163],{"name":13,"role":84,"phone":103},{"lat":165,"lon":166},38.79345,-77.27165,[168],{"name":13,"role":84,"phone":103,"email":169},"clinicaltrials@vandapharma.com",[171],{"name":172,"affiliation":172,"role":173},"Vanda Pharmaceuticals Inc.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":177,"biomarkers":179},[24,20,178,25],"Overweight",[],{"nct_id":4,"found":15,"summary":181,"prompt_version":191},{"design":182,"status":183,"heading":184,"summary":185,"follow_up":186,"word_count":187,"commitments":188,"compensation":189,"drugs_mentioned":190},"This study is interventional and placebo-controlled, meaning some participants will receive Tradipitant and others will receive a placebo. It involves two treatment groups and plans to enroll 280 participants.","completed","Study of Tradipitant for Nausea and Vomiting from GLP-1R Agonists","This study is looking at whether an oral capsule called Tradipitant can help reduce nausea and vomiting caused by GLP-1R agonist medications. These medications are often used for weight management. You might be able to join if you are between 18 and 65 years old, have a Body Mass Index (BMI) between 25 and 40 kg\u002Fm², and do not have serious medical problems like diabetes. The study will compare Tradipitant to a placebo (an inactive capsule) to see if participants taking Tradipitant have fewer vomiting episodes per week. The study aims to enroll 280 participants, but its current recruitment status is unclear.","The primary outcome, vomiting episodes, will be measured at 1 week.",102,"Not specified in the trial record.","Not stated in the trial record.",[36,44],"v2"]