NCT06075667进行中（未招募）3 期
Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 59
- 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 is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.
Participants who have completed the primary 72-week GPHP study and have been off treatment for no more than 12 weeks (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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
- •Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.
- •dyslipidemia
- •pre-hypertension
- •hypertension
- •nonalcoholic fatty liver disease
- •obstructive sleep apnea
- •prediabetes
- •documented preexisting condition of Type 2 Diabetes
- •Participants with Type 2 Diabetes Mellitus (T2DM)
- •Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c<9.0%
排除标准
- •Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
- •Have Type 1 Diabetes
- •Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
- •Are prepubertal (Tanner stage 1).
- •Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
- •Have a history of chronic or acute pancreatitis.
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (Drug)
Tirzepatide
Experimental
Participants will receive tirzepatide subcutaneously (SC).
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Mass Index (BMI)
时间窗: Baseline, Week 72
次要结局
- Percentage of Participants with ≥5% BMI Reduction(Baseline, Week 72)
- Change from Baseline in Body Weight(Baseline, Week 72)
- Change from Baseline in Waist Circumference(Baseline, Week 72)
- Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score(Baseline, Week 72)
- Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts(Baseline, Week 72)
- Change from Baseline in Systolic Blood Pressure(Baseline, Week 72)
- Change from Baseline in Diastolic Blood Pressure(Baseline, Week 72)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 72)
- Change from Baseline in Fasting Glucose(Baseline, Week 72)
- Change from Baseline in Fasting Insulin(Baseline, Week 72)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide(Baseline through Week 72)
研究者
研究点 (59)
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