RecruitingObesityOverweight

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

Eligible age

6–17 yrs

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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.

Sponsor: Eli Lilly and Company

You may qualify if…

✓ 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

You may not qualify if…

✕ 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.