A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)

Open to people ages 6-17

• 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-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.