NCT07817875尚未招募3 期
Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 84
- 主要终点
- Percent Change from Baseline in Body Mass Index (BMI)
研究概览
简要总结
The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks.
Participants who have completed the primary 104-week PW02 study (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •J4M-MC-PW02
- •Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive)
- •a body weight of ≥ 40 kilograms (kg) (88 pounds), and
- •been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart
- •J4M-MC-PWMP
- •Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.
- •Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart [CDC-NCHS, 2022])
排除标准
- •J4M-MC-PW02
- •Have a history of
- •proliferative diabetic retinopathy
- •diabetic macular edema, or
- •nonproliferative diabetic retinopathy that requires acute treatment
- •J4M-MC-PWMP
- •Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:
- •gastric bypass
- •sleeve gastrectomy
- •restrictive bariatric surgery, such as Lap-Band® gastric banding, or
- •any other procedure intended to result in weight reduction.
- •Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.
- •Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.
- •Have HbA1c >9.0% (75 mmol/mol) as measured by central laboratory at screening.
- •Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.
研究组 & 干预措施
Tirzepatide
Experimental
Participants will receive tirzepatide subcutaneously (SC)
干预措施: Tirzepatide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Mass Index (BMI)
时间窗: Baseline, Week 84
次要结局
- Change from Baseline in Fasting Glucose(Baseline, Week 84)
- Percent Change from Baseline in Fasting Insulin(Baseline, Week 84)
- Change from Baseline in Waist Circumference(Baseline, Week 84)
- Change from Baseline in Blood Pressure(Baseline, Week 84)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 84)
- Change from Baseline in Body Weight(Baseline, Week 84)
- Change from Baseline in Pediatric Quality of Life Inventory (PedsQL) Score(Baseline, Week 84)
- Change from Baseline in Child Three-Factor Eating Questionnaire (CTFEQr17) Score(Baseline, Week 84)
- Change from Baseline in Height(Baseline, Week 84)
- Change from Baseline in Alanine Aminotransferase (ALT)(Baseline, Week 84)
- Change from Baseline in Aspartate Aminotransferase (AST)(Baseline, Week 84)
- Treatment-Emergent Suicidality from Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline, Week 84)
- Pharmacokinetics (PK): Average Tirzepatide Concentration at Steady State (Css)(Baseline through Week 84)
研究者
研究点 (84)
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