[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07282340":3,"trial-entities:NCT07282340":209,"trial-summary:NCT07282340":213},{"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":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":49,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":95,"locations":97,"central_contacts":198,"overall_officials":203,"references":207,"see_also_links":208},"NCT07282340","STUDY00161879","Phentermine's Impact on Treatment in Teens","Phentermine's Impact on Treatment in Teens (PhITT): A Randomized Placebo-Controlled Trial of Phentermine for Adolescents With Obesity","RECRUITING","2028-01","2025-11","2026-08-10","2026-06-03","Russell McCulloh, MD","NETWORK",true,"PhITT is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of phentermine (16 mg daily) in adolescents aged 12 to \\\u003C18 years with obesity. Conducted across approximately 10 sites within the IDeA States Pediatric Clinical Trials Network (ISPCTN), the study aims to enroll up to 240 participants and then randomize up to 198 who meet eligibility criteria, randomized in a 2:1 ratio to phentermine or placebo over a 52-week treatment period, followed by a 2-week withdrawal assessment.",null,[19],"Childhood Obesity",[21,22,23,24,25],"Adolescent Obesity","Pediatric Obesity","Weight Loss","BMI Reduction","Phentermine","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},240,"ESTIMATED",[34,39],{"type":35,"name":25,"description":36,"armGroupLabels":37},"DRUG","Phentermine 16 mg administered orally once daily in the morning for 52 weeks. The dose is provided as two 8 mg tablets. Participants also receive lifestyle education handouts at each study visit. The intervention is designed to evaluate the efficacy and safety of phentermine for weight loss in adolescents with obesity.",[38],"Phentermine 16 mg Group",{"type":35,"name":40,"description":41,"armGroupLabels":42},"Placebo","Placebo tablets that are visually identical to phentermine tablets but contain no active pharmaceutical ingredient. Administered orally once daily in the morning for 52 weeks. Participants also receive lifestyle education handouts at each study visit. This control arm is used to evaluate the efficacy and safety of phentermine in adolescents with obesity.",[43],"Placebo Group",[45],{"measure":46,"description":47,"timeFrame":48},"Percent Change in BMI from Baseline at Week 52","Change in body mass index (BMI) expressed as a percentage of baseline BMI at week 52.","52 weeks",[50,53],{"measure":51,"description":52,"timeFrame":48},"Number of Treatment-Emergent Adverse Events (TEAEs)","Count of TEAEs deemed probably or definitely related to study drug, including common side effects",{"measure":54,"description":55,"timeFrame":48},"Number of Treatment-Emergent Adverse Events of Special Interest (TEAESIs)","Count of TEAESIs deemed probably or definitely related to study drug, including tachycardia, hypertension, depression, suicidality, and withdrawal symptoms","ALL","12 Years","17 Years",false,{"inclusion":61,"exclusion":66,"raw_text":94},[62,63,64,65],"Age ≥ 12 years and \\\u003C 18 years at time of consent;","Tanner Staging ≥ 2 at the time of screening;","Obesity (BMI ≥ 95th age- and sex-specific CDC percentile or BMI ≥ 30 kg\u002Fm2);","Biological females must agree to use adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"Contraindications to phentermine in adults such as:","A history of cardiovascular disease (e.g., coronary artery disease, stroke, clinically significant congenital heart disease, clinically significant cardiac arrhythmias, and congestive heart failure);","History of glaucoma;","Current or recent (within 14 days of screening) use of a monoamine oxidase (MAO) inhibitor;","Any previous history of drug dependency or current use of an illicit substance (positive urine drug screen);","Current pregnancy or breastfeeding;","Plans to become pregnant within the study duration;","Known hypersensitivity to sympathomimetic amines;","Current nicotine use or nicotine cessation within 3 months of screening;","Stage 2 hypertension (or greater) or taking any medication to treat hypertension;","Current type 1 or type 2 diabetes mellitus or taking any medication to treat diabetes or prediabetes;","Current or recent (within 3 months of screening) use of prescribed weight loss medication(s)\u002Fmedically prescribed diets (e.g., low calorie, meal replacement\u002Fherbal agents\u002Fdietary supplements or weight loss program);","Current or recent (within 3 months of screening) use of other sympathomimetic amines such as stimulants to treat attention- deficit\u002Fhyperactive disorder;","Use of chronic systemic glucocorticoid therapy (consecutive use of 3 months or more) or other steroid hormone therapy other than oral contraceptives;","Use of tricyclic antidepressants, lithium, levodopa, or dopamine receptor agonists;","History of bariatric surgery;","History or current diagnosis of schizophrenia, psychosis, bipolar disorder, or mental illness requiring hospitalization within 12 months of screening;","History of suicide attempt within 2 years or self-harm within 3 months of screening;","Current Patient Health Questionnaire-9 (PHQ-9) score of ≥ 10;","Current suicidal ideation type 4 or 5 on Columbia Suicide Severity Rating Scale (C-SSRS);","Current Eating Attitudes Test-26 (EAT-26) score ≥ 20 or any history of anorexia or bulimia.","Current condition or disease interfering with metabolism, such as untreated hypo- or hyperthyroidism, Cushing's syndrome;","Current clinically significant hepatic aspartate transaminase (AST) or alanine transaminase (ALT) \\> 3x upper limit of age- and sex-specific normal range or renal disease (creatinine clearance \\\u003C 60 mL\u002Fminute); hypertriglyceridemia (triglyceride ≥ 400 mg\u002FdL) or syndromic or monogenic obesity;","Any clinically significant abnormalities on a standard 12-lead electrocardiogram at baseline;","Heart rate \\> 100 bpm at screening;","Current or recent use of any investigational medication or device or participation in an interventional clinical trial within 30 days of screening;","Any clinically significant medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation, investigational product administration, or interpretation of trial results.","Inclusion criteria\\* include, but are not limited to:\n\n* Age ≥ 12 years and \\\u003C 18 years at time of consent;\n* Tanner Staging ≥ 2 at the time of screening;\n* Obesity (BMI ≥ 95th age- and sex-specific CDC percentile or BMI ≥ 30 kg\u002Fm2);\n* Biological females must agree to use adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.\n\nExclusion criteria\\* include, but are not limited to:\n\n* Contraindications to phentermine in adults such as:\n\n  * A history of cardiovascular disease (e.g., coronary artery disease, stroke, clinically significant congenital heart disease, clinically significant cardiac arrhythmias, and congestive heart failure);\n  * History of glaucoma;\n  * Current or recent (within 14 days of screening) use of a monoamine oxidase (MAO) inhibitor;\n  * Any previous history of drug dependency or current use of an illicit substance (positive urine drug screen);\n  * Current pregnancy or breastfeeding;\n  * Plans to become pregnant within the study duration;\n  * Known hypersensitivity to sympathomimetic amines;\n* Current nicotine use or nicotine cessation within 3 months of screening;\n* Stage 2 hypertension (or greater) or taking any medication to treat hypertension;\n* Current type 1 or type 2 diabetes mellitus or taking any medication to treat diabetes or prediabetes;\n* Current or recent (within 3 months of screening) use of prescribed weight loss medication(s)\u002Fmedically prescribed diets (e.g., low calorie, meal replacement\u002Fherbal agents\u002Fdietary supplements or weight loss program);\n* Current or recent (within 3 months of screening) use of other sympathomimetic amines such as stimulants to treat attention- deficit\u002Fhyperactive disorder;\n* Use of chronic systemic glucocorticoid therapy (consecutive use of 3 months or more) or other steroid hormone therapy other than oral contraceptives;\n* Use of tricyclic antidepressants, lithium, levodopa, or dopamine receptor agonists;\n* History of bariatric surgery;\n* History or current diagnosis of schizophrenia, psychosis, bipolar disorder, or mental illness requiring hospitalization within 12 months of screening;\n* History of suicide attempt within 2 years or self-harm within 3 months of screening;\n* Current Patient Health Questionnaire-9 (PHQ-9) score of ≥ 10;\n* Current suicidal ideation type 4 or 5 on Columbia Suicide Severity Rating Scale (C-SSRS);\n* Current Eating Attitudes Test-26 (EAT-26) score ≥ 20 or any history of anorexia or bulimia.\n* Current condition or disease interfering with metabolism, such as untreated hypo- or hyperthyroidism, Cushing's syndrome;\n* Current clinically significant hepatic aspartate transaminase (AST) or alanine transaminase (ALT) \\> 3x upper limit of age- and sex-specific normal range or renal disease (creatinine clearance \\\u003C 60 mL\u002Fminute); hypertriglyceridemia (triglyceride ≥ 400 mg\u002FdL) or syndromic or monogenic obesity;\n* Any clinically significant abnormalities on a standard 12-lead electrocardiogram at baseline;\n* Heart rate \\> 100 bpm at screening;\n* Current or recent use of any investigational medication or device or participation in an interventional clinical trial within 30 days of screening;\n* Any clinically significant medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation, investigational product administration, or interpretation of trial results.",[96],"CHILD",[98,118,133,148,163,183],{"facility":99,"status":8,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":115},"Pennington Biomedical Research Center","Baton Rouge","Louisiana","70808","United States",[105,110,112],{"name":106,"role":107,"phone":108,"email":109},"Lauren Harrington","CONTACT","225-763-2974","Lauren.Harrington@pbrc.edu",{"name":111,"role":107},"Goff",{"name":113,"role":114},"Stephanie Waldrop, MD, MPH","PRINCIPAL_INVESTIGATOR",{"lat":116,"lon":117},30.44332,-91.18747,{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":103,"contacts":123,"geoPoint":130},"Children's Mercy Hospital","Kansas City","Missouri","64108",[124,128],{"name":125,"role":107,"phone":126,"email":127},"Pete Muenks","816-816-6840","epmuenks@cmh.edu",{"name":129,"role":114},"Helena Laroche, MD",{"lat":131,"lon":132},39.09973,-94.57857,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":103,"contacts":138,"geoPoint":145},"Dartmouth Hitchcock Medical Center","Lebanon","New Hampshire","03756",[139,143],{"name":140,"role":107,"phone":141,"email":142},"Mary M McNally","603-653-6115","Mary.M.McNally@hitchcock.org",{"name":144,"role":114},"Kimberly Dovin, MD",{"lat":146,"lon":147},43.64229,-72.25176,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":103,"contacts":153,"geoPoint":160},"University of New Mexico Health Sciences Center","Albuquerque","New Mexico","87131",[154,158],{"name":155,"role":107,"phone":156,"email":157},"Arielle Padilla, RN","(505) 272-1972","agartn01@salud.unm.edu",{"name":159,"role":114},"Michele Hutchison, MD",{"lat":161,"lon":162},35.08449,-106.65114,{"facility":164,"status":8,"city":165,"state":166,"zip":167,"country":103,"contacts":168,"geoPoint":180},"The University of Oklahoma Health Sciences Children's Hospital","Oklahoma City","Oklahoma","73104",[169,174,178],{"name":170,"role":107,"phone":171,"phoneExt":172,"email":173},"Blair A Hill","405-271-8001","34891","Blair-AppleHill@ou.edu",{"name":175,"role":107,"phone":176,"email":177},"Gina Herbert","405-271-3480","Gina-Herbert@ou.edu",{"name":179,"role":114},"Jeanie Tryggestad, MD",{"lat":181,"lon":182},35.46756,-97.51643,{"facility":184,"status":8,"city":185,"state":186,"zip":187,"country":103,"contacts":188,"geoPoint":195},"Prisma Health-Midlands Children's Hospital","Columbia","South Carolina","29203",[189,193],{"name":190,"role":107,"phone":191,"email":192},"Page Wiggins","803-434-8977","mollie.wiggins@prismahealth.org",{"name":194,"role":114},"Lisa Knight, MD",{"lat":196,"lon":197},34.00071,-81.03481,[199],{"name":200,"role":107,"phone":201,"email":202},"Aubrey VanStory","402-559-4815","aubrey.vanstory@unmc.edu",[204],{"name":13,"affiliation":205,"role":206},"UNMC","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":210,"biomarkers":212},[211],"Obesity",[],{"nct_id":4,"found":15,"summary":214,"prompt_version":224},{"design":215,"status":216,"heading":217,"summary":218,"follow_up":219,"word_count":220,"commitments":221,"compensation":222,"drugs_mentioned":223},"This is a Phase IIb, randomized, double-blind, placebo-controlled study involving up to 240 participants. You would be randomly assigned to receive either phentermine or a placebo.","completed","Phentermine for Childhood Obesity in Teens","This study is looking at how well a medication called phentermine works for weight loss in teenagers with obesity. Phentermine is a drug that helps with weight management. Participants aged 12 to 17 years who have obesity (a Body Mass Index, or BMI, at or above the 95th percentile for their age and sex, or a BMI of 30 kg\u002Fm2 or higher) may be able to join. You would take either phentermine (16 mg daily) or a placebo (an inactive pill that looks the same) for 52 weeks, along with lifestyle education. The main goal is to see how much your BMI changes from the beginning of the study to 52 weeks later. The study plans to enroll up to 240 participants, but the current recruitment status is unclear.","Participants will be followed for 52 weeks during the treatment period, with a 2-week withdrawal assessment afterward.",129,"You would take a pill once daily for 52 weeks and receive lifestyle education handouts at each study visit. There will also be a 2-week period after treatment to assess withdrawal.","Not stated in the trial record.",[25,40],"v2"]