Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 70
- 主要终点
- Percent Change from Baseline in Body Mass Index (BMI)
研究概览
简要总结
The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.
Participants who have completed the primary 72-week GPIX 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.
详细描述
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.
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 body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
- •Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
- •Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).
排除标准
- •Have undergone or plan to undergo a 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 self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
- •Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
- •Have type 2 diabetes or have a HbA1c > 6.4% at screening
- •Have a history of chronic or acute pancreatitis
- •Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
研究组 & 干预措施
Placebo
Participants will receive placebo SC.
干预措施: Placebo (Drug)
Tirzepatide
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
A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity
时间窗: Baseline, Week 72
次要结局
- Percentage of Participants Who Achieve BMI Reduction of ≥ 5%(Week 72)
- Percentage of Participants Who Achieve BMI Reduction of ≥ 10%(Week 72)
- Percentage of Participants Who Achieve BMI Reduction of ≥ 15%(Week 72)
- Percentage of Participants Who Achieve BMI Reduction of ≥ 20%(Week 72)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 72)
- Percent Change from Baseline in Triglycerides(Baseline, Week 72)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 72)
- Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)(Baseline, Week 72)
- Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)(Baseline, Week 72)
- Change from Baseline in Diastolic Blood Pressure (DBP)(Baseline, Week 72)
- Percent Change from Baseline in Body Weight(Baseline, Week 72)
- Change from Baseline in Waist Circumference(Baseline, Week 72)