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A Study for Children and Teens with Obesity or Overweight

This study is a platform trial, meaning it's designed to test different treatments for children and teenagers (ages 6 to 17) who have obesity or are overweight. You might receive either Orforglipron, an oral medication, or a placebo (an inactive pill that looks like the study drug). To join, you must have tried to lose weight before through diet and exercise for at least three months without enough success, and meet specific Body Mass Index (BMI) criteria. The main goal is to see how many participants are assigned to each treatment group over 72 weeks. This study aims to create a way to evaluate how safe and effective different medications are for managing weight in young people.

Study design
This is an interventional study planning to enroll 125 participants. It is structured as a platform trial, which means different treatments can be tested within the same overall study framework.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from baseline up to 72 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06672549

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

Recruiting
PHASE3Ages 6–17InterventionalScreening
Eli Lilly and Company
~125 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:OrforglipronPlacebo

At a glance

Recruiting sites
1 of 117 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Allocated to Each ISA
Measured over Baseline to Week 72

Conditions

Obesity
Overweight

Explore related trials

ObesityOverweight

Where it's being run

117 sites across 41 states
Japan9
Poland9
Italy7
United Kingdom7
Texas6
Israel6
Mexico6
Spain6

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants Allocated to Each ISABaseline to Week 72