Phentermine's Impact on Treatment in Teens (PhITT): A Randomized Placebo-Controlled Trial of Phentermine for Adolescents With Obesity
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 6
- 主要终点
- Percent Change in BMI from Baseline at Week 52
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study. Participants, care providers, investigators, and outcomes assessors are blinded to treatment assignment. Only the site pharmacist is unblinded to facilitate dispensing of phentermine or placebo. Randomization is centralized and stratified by sex using a permuted block design. Blinding is maintained throughout the study unless unblinding is required for safety reasons.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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.
排除标准
- •* 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.
研究组 & 干预措施
Placebo Group
Participants in this arm will receive placebo tablets that are visually identical to the phentermine tablets but contain no active pharmaceutical ingredient. The placebo will be taken orally once daily in the morning for 52 weeks. All participants will also receive lifestyle education handouts at each study visit. This arm serves as the control group for evaluating the efficacy and safety of phentermine in adolescents with obesity.
干预措施: Placebo (Drug)
Phentermine 16 mg Group
Participants in this arm will receive phentermine 16 mg daily, administered as two 8 mg tablets taken orally once
干预措施: Phentermine (Drug)
结局指标
主要结局
Percent Change in BMI from Baseline at Week 52
时间窗: 52 weeks
Change in body mass index (BMI) expressed as a percentage of baseline BMI at week 52.
Percent Change in BMI from Baseline at Week 52
时间窗: 52 weeks
Change in body mass index (BMI) expressed as a percentage of baseline BMI at week 52.
次要结局
- Number of Treatment-Emergent Adverse Events (TEAEs)(52 weeks)
- Number of Treatment-Emergent Adverse Events of Special Interest (TEAESIs)(52 weeks)
- Number of Treatment-Emergent Adverse Events (TEAEs)(52 weeks)
- Number of Treatment-Emergent Adverse Events of Special Interest (TEAESIs)(52 weeks)
研究者
Russell McCulloh, MD
Associate Vice chancellor for Clinical Research, UNMC
Heartland DCOC