Phentermine's Impact on Treatment in Teens

Официальное название

Phentermine's Impact on Treatment in Teens (PhITT): A Randomized Placebo-Controlled Trial of Phentermine for Adolescents With Obesity

Обзор

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 \<18 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.

Вмешательства

• Препарат Phentermine
  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.
• Препарат 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.

Первичные конечные точки

• Percent Change in BMI from Baseline at Week 52 [Срок оценки: 52 weeks]

Вторичные конечные точки (2)

• Number of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: 52 weeks]
• Number of Treatment-Emergent Adverse Events of Special Interest (TEAESIs) [Срок оценки: 52 weeks]

Критерии участия

Inclusion criteria\* include, but are not limited to:

• Age ≥ 12 years and < 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/m2);
• Biological females must agree to use adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.

Exclusion criteria\* include, but are not limited to:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of New Mexico Health Sciences Center — Albuquerque
• Prisma Health-Midlands Children's Hospital — Columbia

Идентификаторы

NCT: NCT07282340 · STUDY00161879 · U24OD038400

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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