RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe medicines are and how well they work for long-term weight management. It is for children and teens with obesity, or teens with overweight and at least one weight-related health problem.

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Tried at least one diet and exercise counseling program for 3 months or more before screening, but did not lose enough weight.
  • Have obesity: a BMI at or above the 95th percentile for age and sex. BMI is a measure of weight compared with height; this range is higher than about 95 out of 100 peers.
  • Or, be age 12 to under 18 with overweight: a BMI from the 85th to below the 95th percentile for age and sex, plus at least one of the health problems listed below.
  • For teens with overweight, health problems that qualify include high blood pressure, type 2 diabetes, prediabetes (blood sugar above normal), unhealthy blood fat levels, sleep apnea (breathing that stops and starts during sleep), or liver disease linked to fat buildup, with or without liver swelling.

Who can't join

  • Have had or plan to have a weight-loss procedure during the study, such as stomach bypass, sleeve surgery, or a stomach band.
  • Have obesity caused by another condition, such as a hormone, brain, or genetic condition, or sudden obesity that suggests another cause.
  • You or your parent or guardian report that you lost more than 11 pounds in the 90 days before screening.
  • Have type 1 diabetes or a history of ketoacidosis (dangerous acid buildup in the blood) or a hyperosmolar state (very high blood sugar with severe loss of body water).
  • Have an HbA1c above 9.0% at screening. This blood test measures average blood sugar over the past few months.
  • You or a family member have had medullary thyroid cancer or Multiple Endocrine Neoplasia Syndrome Type 2, a condition that can cause tumors in glands.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (50)

AZ

CA

CO

CT

FL

GA

IL

IN

KY

LA

MA

  • Boston Children's Hospital · Boston, MA 02115Margaret Stefater-Richards · Principal investigatorMore trials in Boston

MD

MI

MN

MO

MS

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research · Gulfport, MS 39503-2637 · Study contact · 228-206-1283Paul Matherne · Principal investigatorMore trials in Gulfport

NC

NE

NY

OH

OK

  • University of Oklahoma Health Sciences Center · Oklahoma City, OK 73104Jeanie Tryggestad · Principal investigatorMore trials in Oklahoma City

PA

SC

TN

TX

UT

VA

  • VCU Health - Center for Endocrinology Diabetes and Metabolism · Richmond, VA 23229-3156 · Study contact · 804-628-6674Edmond Wickham · Principal investigatorMore trials in Richmond

WA

  • Seattle Children's Research Institute - Hughes Building - PIN · Seattle, WA 98101 · Study contact · 425-786-3784Kalie Tommerdale · Principal investigatorMore trials in Seattle
  • MultiCare Health System - Mary Bridge Children's Health Center · Tacoma, WA 98405 · Study contact · 253-403-0776Bhuvana Sunil · Principal investigatorMore trials in Tacoma