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.

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.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.