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A trial for treating obesity in children and adolescents

A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

PHASE3 · Eli Lilly and Company · NCT06672549

This study is testing different medications to see if they can help kids and teens aged 12 to 17 who struggle with obesity and have tried to lose weight before.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment125 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorEli Lilly and Company (industry)
Locations50 sites (Ventura, California and 49 other locations)
Trial IDNCT06672549 on ClinicalTrials.gov

What this trial studies

This Phase 3 platform trial aims to evaluate the safety and efficacy of pharmacologic agents for managing obesity and overweight in pediatric participants. It establishes entry criteria for new participants and allows for independent testing of various interventions as they become available. The trial will report results once all interventions have been completed, focusing on children aged 12 to under 18 years with a history of unsuccessful weight loss efforts and related health issues.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 12 to under 18 years with obesity or overweight and at least one weight-related comorbidity.

Not a fit: Patients who have undergone or plan to undergo weight reduction procedures during the study will not benefit from this trial.

Why it matters

Potential benefit: If successful, this trial could provide effective pharmacologic treatments for managing obesity in pediatric patients, improving their overall health and quality of life.

How similar studies have performed: Other studies have shown promise in pharmacologic interventions for obesity, making this approach both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Ventura, California and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Obesity, Overweight

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.