Actively Recruiting
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
Led by Eli Lilly and Company · Updated on 2026-05-19
125
Participants Needed
50
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for obesity or overweight in children and teenagers aged 6 to 17. This phase 3 pediatric chronic weight management study aims to create a framework to evaluate the safety and effectiveness of medicines for managing weight in this young population. The study is designed as a master protocol, allowing multiple interventions to be tested independently as they become available. Participants will be randomly assigned to receive either the drug Orforglipron or a placebo, both given by mouth. Each intervention will follow specific details within the study arms. The study periods include enrollment under the master protocol and independent substudies for each intervention. Results will be reported when all intervention substudies are completed. Throughout the study, participants will have regular assessments to monitor their weight and health. Researchers will track the number of participants assigned to each intervention from the start through week 72. The study includes evaluations of safety and effect on body weight, with ongoing monitoring to understand the impact of the treatments. Total participation may last up to about 72 weeks, with periodic visits and evaluations.
CONDITIONS
Brief Title
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a history of at least 1 unsuccessful effort to lose weight after a structured lifestyle program of diet and exercise counseling for at least 3 months before screening.
- Obesity defined as BMI equal to or above the 95th percentile for age and sex on the CDC-NCHS 2022 growth chart.
- For participants aged 12 to under 18 years, overweight defined as BMI between the 85th and 95th percentile for age and sex with at least one weight-related condition such as hypertension, type 2 diabetes, prediabetes, dyslipidemia, obstructive sleep apnea, or metabolic dysfunction-associated liver disease.
You will not qualify if you...
- Have had or plan to have weight reduction surgery during the study, including gastric bypass, sleeve gastrectomy, Lap-Band gastric banding, or other weight loss procedures.
- Have a diagnosis of a secondary cause of obesity or abrupt onset of obesity suggesting such causes like hypothalamic, monogenetic, syndromic, or endocrine disorders.
- Have lost more than 5 kg (11 lbs) in the 90 days before screening.
- Have type 1 diabetes or history of ketoacidosis or hyperosmolar state.
- Have HbA1c greater than 9.0% as measured at screening.
- Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 weeks
Participants receive orforglipron or placebo orally as part of the intervention detailed in the specific study arms.
Visits scheduled as per the intervention protocol
Trial Site Locations
Total: 50 locations
1
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California, United States, 93003-5369
Not Yet Recruiting
2
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, United States, 06519
Not Yet Recruiting
3
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
Not Yet Recruiting
4
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, United States, 30329
Not Yet Recruiting
5
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Not Yet Recruiting
6
Velocity Clinical Research
Lafayette, Louisiana, United States, 70508
Not Yet Recruiting
7
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Gulfport, Mississippi, United States, 39503-2637
Not Yet Recruiting
8
Sundance Clinical Research
St Louis, Missouri, United States, 63141-7068
Not Yet Recruiting
9
Velocity Clinical Research
Omaha, Nebraska, United States, 68134
Not Yet Recruiting
10
Lucas Research, Inc
Morehead City, North Carolina, United States, 28557
Actively Recruiting
11
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
12
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, United States, 37204
Not Yet Recruiting
13
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston, Texas, United States, 77065
Not Yet Recruiting
14
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston, Texas, United States, 77071-1008
Not Yet Recruiting
15
Martin Diagnostic Clinic
Tomball, Texas, United States, 77375-3332
Not Yet Recruiting
16
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States, 84088
Not Yet Recruiting
17
L2IP - Instituto de Pesquisas Clínicas
Brasília, Brazil, 70200730
Not Yet Recruiting
18
Hospital Universitario de Caxias do Sul
Caxias do Sul, Brazil, 95070-560
Not Yet Recruiting
19
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, Brazil, 01228-000
Not Yet Recruiting
20
Yitzhak Shamir Medical Center
Beer Yaacov, Israel, 70300
Not Yet Recruiting
21
Shaare Zedek Medical Center
Jerusalem, Israel, 9013102
Not Yet Recruiting
22
Chaim Sheba Medical Center
Ramat Gan, Israel, 5262100
Not Yet Recruiting
23
Azienda Ospedaliero Universitaria Meyer
Florence, Italy, 50139
Not Yet Recruiting
24
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy, 28100
Not Yet Recruiting
25
Ospedale Pediatrico Bambino Gesù
Roma, Italy, 165
Not Yet Recruiting
26
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Italy, 37126
Not Yet Recruiting
27
Saitama Medical University Hospital
Iruma-Gun, Japan, 350-0495
Not Yet Recruiting
28
Isesaki Municipal Hospital
Isesaki-shi, Japan, 372-0817
Not Yet Recruiting
29
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Not Yet Recruiting
30
Tokyo Medical Center
Meguro-Ku, Japan, 152-0021
Not Yet Recruiting
31
Shiga General Hospital
Moriyama, Japan, 524-8524
Not Yet Recruiting
32
Nara Prefecture General Medical Center
Nara, Japan, 630-8054
Not Yet Recruiting
33
Osaka City General Hospital
Osaka, Japan, 534-0021
Not Yet Recruiting
34
Sagaekiminami Clinic
Saga, Japan, 840-0801
Not Yet Recruiting
35
Shikoku Medical Center for Children and Adults
Zentsujichó, Japan, 765-8507
Not Yet Recruiting
36
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
Culiacán, Mexico, 80000
Not Yet Recruiting
37
PanAmerican Clinical Research - Guadalajara
Guadalajara, Mexico, 44670
Not Yet Recruiting
38
Innovacion y Desarrollo de Estrategias en Salud SA de CV
Mexico City, Mexico, 14090
Not Yet Recruiting
39
Hospital Angeles Puebla
Puebla City, Mexico, 72190
Not Yet Recruiting
40
Krakowskie Centrum Medyczne
Krakow, Poland, 31-501
Not Yet Recruiting
41
Instytut Diabetologii
Warsaw, Poland, 02-117
Not Yet Recruiting
42
FutureMeds - Targowek
Warsaw, Poland, 03-291
Not Yet Recruiting
43
FutureMeds sp. z o. o.
Wroclaw, Poland, 53-673
Not Yet Recruiting
44
Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom, S75 2EP
Not Yet Recruiting
45
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Not Yet Recruiting
46
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Not Yet Recruiting
47
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Not Yet Recruiting
48
Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ
Not Yet Recruiting
49
Hull Royal Infirmary - MAIN
Hull, United Kingdom, HU3 2JZ
Not Yet Recruiting
50
Alder Hey Children's Hospital
Liverpool, United Kingdom, L14 5AB
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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