A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

Launched by ELI LILLY AND COMPANY · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called orforglipron (LY3502970) to see if it can help adolescents who are overweight or obese, especially those with related health issues like high blood pressure or diabetes. The study will compare how well this medication works when taken daily compared to a placebo, which is a pill that looks like the medication but has no active ingredients. The trial lasts about 18 months, and it is currently open for participants to join.

To be eligible for this study, participants need to be between the ages of 12 and 17 and have a history of struggling to lose weight despite trying a structured weight loss program. They must also have a body mass index (BMI) that is considered obese or overweight based on their age and gender. Participants will be closely monitored throughout the study, and they can expect regular check-ins to track their health and progress. It's important to note that this study is not open to everyone; for instance, individuals with certain medical conditions or who have recently lost significant weight may not qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • J4M-MC-PWMP
• • 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
• • 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:
• • J4M-MC-PW01
• • Prepubertal (Tanner stage 1)
• • Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening
• • J4M-MC-PWMP
• * 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 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.