A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
ADVANCE
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
2 other identifiers
interventional
125
8 countries
50
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started Nov 2024
Typical duration for phase_3 obesity
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedStudy Start
First participant enrolled
November 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 20, 2026
April 1, 2026
2.2 years
November 1, 2024
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Allocated to Each ISA
Baseline to Week 72
Study Arms (1)
Orforglipron (ISA PW01)
EXPERIMENTALParticipants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.
Interventions
Administered orally. ISA specific interventions will be listed in the ISA.
Administered orally. ISA specific interventions will be listed in the ISA.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura, California, 93003-5369, United States
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven, Connecticut, 06519, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, 30329, United States
Ann and Robert Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Velocity Clinical Research
Lafayette, Louisiana, 70508, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Gulfport, Mississippi, 39503-2637, United States
Sundance Clinical Research
St Louis, Missouri, 63141-7068, United States
Velocity Clinical Research
Omaha, Nebraska, 68134, United States
Lucas Research, Inc
Morehead City, North Carolina, 28557, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 37204, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston, Texas, 77065, United States
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston, Texas, 77071-1008, United States
Martin Diagnostic Clinic
Tomball, Texas, 77375-3332, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088, United States
L2IP - Instituto de Pesquisas Clínicas
Brasília, 70200730, Brazil
Hospital Universitario de Caxias do Sul
Caxias do Sul, 95070-560, Brazil
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, 01228-000, Brazil
Yitzhak Shamir Medical Center
Beer Yaacov, 70300, Israel
Shaare Zedek Medical Center
Jerusalem, 9013102, Israel
Chaim Sheba Medical Center
Ramat Gan, 5262100, Israel
Azienda Ospedaliero Universitaria Meyer
Florence, 50139, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100, Italy
Ospedale Pediatrico Bambino Gesù
Roma, 165, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, 37126, Italy
Saitama Medical University Hospital
Iruma-Gun, 350-0495, Japan
Isesaki Municipal Hospital
Isesaki-shi, 372-0817, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Tokyo Medical Center
Meguro-Ku, 152-0021, Japan
Shiga General Hospital
Moriyama, 524-8524, Japan
Nara Prefecture General Medical Center
Nara, 630-8054, Japan
Osaka City General Hospital
Osaka, 534-0021, Japan
Sagaekiminami Clinic
Saga, 840-0801, Japan
Shikoku Medical Center for Children and Adults
Zentsujichó, 765-8507, Japan
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
Culiacán, 80000, Mexico
PanAmerican Clinical Research - Guadalajara
Guadalajara, 44670, Mexico
Innovacion y Desarrollo de Estrategias en Salud SA de CV
Mexico City, 14090, Mexico
Hospital Angeles Puebla
Puebla City, 72190, Mexico
Krakowskie Centrum Medyczne
Krakow, 31-501, Poland
Instytut Diabetologii
Warsaw, 02-117, Poland
FutureMeds - Targowek
Warsaw, 03-291, Poland
FutureMeds sp. z o. o.
Wroclaw, 53-673, Poland
Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP, United Kingdom
Bristol Royal Hospital for Children
Bristol, BS2 8BJ, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Northwick Park Hospital
Harrow, HA1 3UJ, United Kingdom
Hull Royal Infirmary - MAIN
Hull, HU3 2JZ, United Kingdom
Alder Hey Children's Hospital
Liverpool, L14 5AB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2024
First Posted
November 4, 2024
Study Start
November 18, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.