Evaluating Orforglipron for Adolescents with Obesity or Overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy, safety, and pharmacokinetics of orforglipron, an oral medication, compared to a placebo in adolescents who are obese or overweight with related health issues. Participants will engage in the study for approximately 18 months, during which their weight and health outcomes will be closely monitored. The study is designed to provide insights into how well orforglipron can help manage weight and associated comorbidities in this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Saitama Medical University Hospital
  Iruma-Gun, Japan Recruiting
• Isesaki Municipal Hospital
  Isesaki-shi, Japan Recruiting
• Tokyo Medical Center
  Meguro-Ku, Japan Recruiting
• Shiga General Hospital
  Moriyama, Japan Recruiting
• Nara Prefecture General Medical Center
  Nara, Japan Recruiting
• Osaka City General Hospital
  Osaka, Japan Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.