Phentermine's Impact on Treatment in Teens

Exclusion Criteria

• •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)/medically prescribed diets (e.g., low calorie, meal replacement/herbal agents/dietary 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/hyperactive 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 \< 60 mL/minute); hypertriglyceridemia (triglyceride ≥ 400 mg/dL) 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.