A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 148
- 主要终点
- Number of Participants Allocated to Each ISA
研究概览
简要总结
The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.
详细描述
The PWMP establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. PWMP results will be reported when all the ISA's complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]); OR
- •Applies to participant age between 12 and <18 years old. 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 (CDC-NCHS, 2022), and at least 1 weight-related comorbidity,
- •hypertension
- •type 2 diabetes (T2D)
- •prediabetes
- •dyslipidemia
- •obstructive sleep apnea
- •metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction-associated steatotic liver disease (MASLD)
排除标准
- •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 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 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
Orforglipron (ISA PW01)
Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.
干预措施: Placebo (Drug)
Orforglipron (ISA PW01)
Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.
干预措施: Orforglipron (Drug)
结局指标
主要结局
Number of Participants Allocated to Each ISA
时间窗: Baseline to Week 72
次要结局
未报告次要终点