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 (J4M-MC-PWMP)

Eli Lilly Japan K.K.0 个研究点目标入组 125 人开始时间: 2025年1月21日最近更新: 2025年1月24日

试验速览

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•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)

•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-BandR 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.

Number of Participants Allocated to Each ISA [ Time Frame: Baseline to Week 72

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