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
- University of Arizona · Tucson, AZ 85721 · Study contact · 520-626-8000Sunil Sinha · Principal investigatorMore trials in Tucson
CA
- Loma Linda University School of Medicine · Loma Linda, CA 92354Prashanth Porayette · Principal investigatorMore trials in Loma Linda
- Childrens Hospital of Los Angeles · Los Angeles, CA 90027Alaina Vidmar · Principal investigatorMore trials in Los Angeles
- UCLA Mattel Children's Hospital · Los Angeles, CA 90095Vibha Singhal · Principal investigatorMore trials in Los Angeles
- Children's Hospital of Orange County - Orange · Orange, CA 92868Amruta Thakkar · Principal investigatorMore trials in Orange
- Carey Chronis MD Pediatric, Infant and Adolescent Medicine · Oxnard, CA 93030 · Study contact · 805-483-1185 x.947Carey Chronis · Principal investigatorMore trials in Oxnard
CO
- Children's Hospital Colorado · Colorado Springs, CO 80920-7843Melanie Cree · Principal investigatorMore trials in Colorado Springs
CT
- Yale School of Medicine - Yale Diabetes Center (YDC)) Trials · New Haven, CT 06519 · Study contact · 203-410-8509Michelle Van Name · Principal investigatorMore trials in New Haven
- Stamford Therapeutics Consortium · Stamford, CT 06905 · Study contact · 727-544-4842David Radin · Principal investigatorMore trials in Stamford
FL
- Florida Hospital- Center for Pediatric Research · Orlando, FL 32803 · Study contact · 407-303-9826Konda Reddy · Principal investigatorMore trials in Orlando
- Nemours Children's Health · Orlando, FL 32827Miles Yu · Principal investigatorMore trials in Orlando
- All Childrens Hospital · St. Petersburg, FL 33701 · Study contact · 727-767-2389Raquel Hernandez · Principal investigatorMore trials in St. Petersburg
GA
- Children's Healthcare of Atlanta - Center for Advanced Pediatrics · Atlanta, GA 30329 · Study contact · 404-712-4731; 404-785-5686Daniel Hsia · Principal investigatorMore trials in Atlanta
IL
- Ann and Robert Lurie Children's Hospital of Chicago · Chicago, IL 60611 · Study contact · 312-503-1499Justin Ryder · Principal investigatorMore trials in Chicago
- University of Illinois at Chicago · Chicago, IL 60612 · Study contact · 773-702-2879Shruti Sakhuja · Principal investigatorMore trials in Chicago
IN
- Riley Hospital for Children · Indianapolis, IN 46202Sara Naramore · Principal investigatorMore trials in Indianapolis
KY
- Norton Children's Endocrinology · Louisville, KY 40202 · Study contact · 502-588-2590Sara Watson · Principal investigatorMore trials in Louisville
LA
- Velocity Clinical Research · Lafayette, LA 70508 · Study contact · 337-519-4742Jibran Atwi · Principal investigatorMore trials in Lafayette
MA
- Boston Children's Hospital · Boston, MA 02115Margaret Stefater-Richards · Principal investigatorMore trials in Boston
MD
- Johns Hopkins Children's Center · Baltimore, MD 21287 · Study contact · 410-955-8769Gihan Naguib · Principal investigatorMore trials in Baltimore
MI
- Helen Devos Childrens' Hospital - PIN · Grand Rapids, MI 49503-2560 · Study contact · 616-486-6113Miriam Vos · Principal investigatorMore trials in Grand Rapids
MN
- University of Minnesota Masonic Children's Hospital · Minneapolis, MN 55454 · Study contact · 612-625-3623Claudia Fox · Principal investigatorMore trials in Minneapolis
- Mayo Clinic - PIN · Rochester, MN 55905-0001 · Study contact · 507-538-7804Seema Kumar · Principal investigatorMore trials in Rochester
- Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center · Saint Paul, MN 55102-3354 · Study contact · 651-220-5730Jennifer Abuzzahab · Principal investigatorMore trials in Saint Paul
MO
- Sundance Clinical Research · St Louis, MO 63141-7068 · Study contact · 314-567-3377Delores Chantal Dotson · Principal investigatorMore trials in St Louis
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
- UNC Children's Hospital · Chapel Hill, NC 27514Nina Jain · Principal investigatorMore trials in Chapel Hill
- Duke Children's Primary Care · Durham, NC 27704-2102Sarah Armstrong · Principal investigatorMore trials in Durham
- Lucas Research, Inc · Morehead City, NC 28557 · Study contact · 252-222-5700 ext. 195Kathryn Lucas · Principal investigatorMore trials in Morehead City
NE
- Omaha Childrens Hospital · Omaha, NE 68114Alvaro Flores Lopez · Principal investigatorMore trials in Omaha
- Velocity Clinical Research · Omaha, NE 68134 · Study contact · 402-933-6500Brandon Essink · Principal investigatorMore trials in Omaha
NY
- UBMD Pediatrics · Buffalo, NY 14203Lucy Mastrandrea · Principal investigatorMore trials in Buffalo
OH
- Cleveland Clinic · Cleveland, OH 44195 · Study contact · 216-636-2828Roy Kim · Principal investigatorMore trials in Cleveland
- Nationwide Children's Hospital · Columbus, OH 43205Joan Han · Principal investigatorMore trials in Columbus
OK
- University of Oklahoma Health Sciences Center · Oklahoma City, OK 73104Jeanie Tryggestad · Principal investigatorMore trials in Oklahoma City
PA
- UPMC Children's Hospital of Pittsburgh · Pittsburgh, PA 15224 · Study contact · 412-692-6935Silva Arslanian · Principal investigatorMore trials in Pittsburgh
SC
- Coastal Pediatric Associates · Charleston, SC 29414 · Study contact · 843-518-5646Stephen Stripling · Principal investigatorMore trials in Charleston
- Medical University of South Carolina Children Hospital · Charleston, SC 29425 · Study contact · 843-792-0603Christine San Giovanni · Principal investigatorMore trials in Charleston
TN
- Vanderbilt Health One Hundred Oaks · Nashville, TN 37204 · Study contact · 615-322-6000Jennifer Kelley · Principal investigatorMore trials in Nashville
TX
- Dell Children's Medical Center - PIN · Austin, TX 78723-3079Gunjan Dokania · Principal investigatorMore trials in Austin
- Driscoll Children's Hospital · Corpus Christi, TX 78411 · Study contact · 361-694-4455Ana Paez · Principal investigatorMore trials in Corpus Christi
- McGovern Medical School · Houston, TX 77030-1521 · Study contact · 713-500-7257Mona Eissa · Principal investigatorMore trials in Houston
- Texas Childrens Hospital · Houston, TX 77030 · Study contact · 713-798-0391Stephanie Sisley · Principal investigatorMore trials in Houston
- Dynamed Clinical Research, LP d/b/a DM Clinical Research · Houston, TX 77065 · Study contact · 281-517-0550Kashif Ali · Principal investigatorMore trials in Houston
- La Providence Pediatrics Clinic - Chemidox Clinical Trials · Houston, TX 77071-1008 · Study contact · 833-324-3643Ifeyinwa Onwudiwe · Principal investigatorMore trials in Houston
- Martin Diagnostic Clinic · Tomball, TX 77375-3332 · Study contact · 281-517-0550Helen Shpats · Principal investigatorMore trials in Tomball
UT
- Velocity Clinical Research, Salt Lake City · West Jordan, UT 84088 · Study contact · 801-542-8190Barbara Rizzardi · Principal investigatorMore trials in West Jordan
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