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

Launched by ELI LILLY AND COMPANY · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial, called LY900040, is looking for children and teenagers who are struggling with obesity or being overweight. The main goal is to test new medications that could help them manage their weight safely and effectively. To be eligible for this study, participants need to be between the ages of 12 and 18, have tried to lose weight through diet and exercise without success, and meet specific weight criteria based on their age and sex. For example, they must have a body mass index (BMI) that is at or above the 95th percentile for obesity, or at least the 85th percentile for overweight, along with a related health issue like high blood pressure or type 2 diabetes.

If your child joins the trial, they will be part of a research team that monitors their health closely while they receive the study medication. Throughout the trial, they will have regular check-ins to assess their progress and any side effects. It's important to note that children who are planning to have weight loss surgery or have certain medical conditions related to their weight may not be eligible for this study. This trial is currently recruiting participants, and it's a chance to contribute to important research that could help other kids facing similar challenges in the future.

Gender

ALL

Eligibility criteria

• 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.