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

May 18, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The PWMP establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. PWMP results will be reported when all the ISA's complete.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Brazil
      • Brasília, Brazil, 70200730
        • Not yet recruiting
        • L2IP - Instituto de Pesquisas Clínicas
        • Contact:
          • Phone Number: 556134454300
        • Principal Investigator:
          • Eduardo Vasconcellos
      • Caxias do Sul, Brazil, 95070-560
        • Not yet recruiting
        • Hospital Universitario de Caxias do Sul
        • Principal Investigator:
          • Marcia Inês Boff Rissotto
        • Contact:
          • Phone Number: (555) 432-1827 x37
      • São Paulo, Brazil, 01228-000
        • Not yet recruiting
        • CPQuali Pesquisa Clínica Sao Paulo
        • Principal Investigator:
          • Francisco Samuel Magalhaes Lima
        • Contact:
          • Phone Number: 551127766801
  • Israel
      • Beer Yaacov, Israel, 70300
        • Not yet recruiting
        • Yitzhak Shamir Medical Center
        • Contact:
          • Phone Number: 972537346636
        • Principal Investigator:
          • Marianna Rachmiel
      • Jerusalem, Israel, 9013102
        • Not yet recruiting
        • Shaare Zedek Medical Center
        • Principal Investigator:
          • Floris Levy-Khademi
        • Contact:
          • Phone Number: 972504021504
      • Ramat Gan, Israel, 5262100
        • Not yet recruiting
        • Chaim Sheba Medical Center
        • Contact:
          • Phone Number: 97235305015
        • Principal Investigator:
          • Noah Gruber
  • Italy
      • Florence, Italy, 50139
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Meyer
        • Principal Investigator:
          • Stefano Stagi
      • Novara, Italy, 28100
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Maggiore Della Carità
        • Principal Investigator:
          • Ivana Rabbone
      • Roma, Italy, 165
        • Not yet recruiting
        • Ospedale Pediatrico Bambino Gesu
        • Principal Investigator:
          • Marco Cappa
      • Verona, Italy, 37126
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
        • Principal Investigator:
          • Claudio Maffeis
  • Japan
      • Iruma-Gun, Japan, 350-0495
        • Not yet recruiting
        • Saitama Medical University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Toru Kikuchi
      • Isesaki-shi, Japan, 372-0817
        • Not yet recruiting
        • Isesaki Municipal Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yoko Takano
      • Kyoto, Japan, 602-8566
        • Not yet recruiting
        • University Hospital,Kyoto Prefectural University of Medicine
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Satoru Sugimoto
      • Meguro-Ku, Japan, 152-0021
        • Not yet recruiting
        • Tokyo Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masashi Miharu
      • Moriyama, Japan, 524-8524
        • Not yet recruiting
        • Shiga General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Katsuyuki Matsui
      • Nara, Japan, 630-8054
        • Not yet recruiting
        • Nara Prefecture General Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Sayaka Yoshida
      • Osaka, Japan, 534-0021
        • Not yet recruiting
        • Osaka City General Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Jun Mori
      • Saga, Japan, 840-0801
        • Not yet recruiting
        • Sagaekiminami Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Tateo Kuno
      • Zentsujichó, Japan, 765-8507
        • Not yet recruiting
        • Shikoku Medical Center for Children and Adults
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takafumi Okada
  • Mexico
      • Culiacán, Mexico, 80000
        • Not yet recruiting
        • Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
        • Principal Investigator:
          • Angeles Rodriguez Sanchez
        • Contact:
          • Phone Number: (+52) 55 5402 9474
      • Guadalajara, Mexico, 44670
        • Not yet recruiting
        • PanAmerican Clinical Research - Guadalajara
        • Principal Investigator:
          • Ana Lopez Beltran
        • Contact:
          • Phone Number: 33 16 05 20 31
      • Mexico City, Mexico, 14090
        • Not yet recruiting
        • Innovacion y Desarrollo de Estrategias en Salud SA de CV
        • Contact:
          • Phone Number: 5536558005
        • Principal Investigator:
          • Veronica Garcia Samano
      • Puebla City, Mexico, 72190
        • Not yet recruiting
        • Hospital Angeles Puebla
        • Principal Investigator:
          • Margarita Barrientos
        • Contact:
          • Phone Number: 22 22 65 73 19
  • Poland
      • Krakow, Poland, 31-501
        • Not yet recruiting
        • Krakowskie Centrum Medyczne
        • Principal Investigator:
          • Ewelina Malec
      • Warsaw, Poland, 02-117
        • Not yet recruiting
        • Instytut Diabetologii
        • Principal Investigator:
          • Ewa Pankowska
      • Warsaw, Poland, 03-291
        • Not yet recruiting
        • FutureMeds - Targówek
        • Principal Investigator:
          • Anna Liber
      • Wroclaw, Poland, 53-673
        • Not yet recruiting
        • FutureMeds sp. z o. o.
        • Principal Investigator:
          • Paulina Ludziak
  • United Kingdom
      • Barnsley, United Kingdom, S75 2EP
        • Not yet recruiting
        • Barnsley Hospital NHS Foundation Trust
        • Principal Investigator:
          • Rajeev Gupta
        • Contact:
          • Phone Number: 01226 432860
      • Bristol, United Kingdom, BS2 8BJ
        • Not yet recruiting
        • Bristol Royal Hospital for Children
        • Principal Investigator:
          • Dinesh Giri
        • Contact:
          • Phone Number: 0117 342 0183
      • Cambridge, United Kingdom, CB2 0QQ
        • Not yet recruiting
        • Addenbrookes Hospital
        • Principal Investigator:
          • Ken Ong
        • Contact:
          • Phone Number: 07824 302285
      • Dundee, United Kingdom, DD1 9SY
        • Not yet recruiting
        • Ninewells Hospital
        • Principal Investigator:
          • Nicholas Conway
        • Contact:
          • Phone Number: (44138) 238-8385
      • Harrow, United Kingdom, HA1 3UJ
        • Not yet recruiting
        • Northwick Park Hospital
        • Principal Investigator:
          • Nilanjana Ray
        • Contact:
          • Phone Number: 020 8864 3232
      • Hull, United Kingdom, HU3 2JZ
        • Not yet recruiting
        • Hull Royal Infirmary - MAIN
        • Contact:
          • Phone Number: 01482 875875
        • Principal Investigator:
          • Sanjay Gupta
      • Liverpool, United Kingdom, L14 5AB
        • Not yet recruiting
        • Alder Hey Children's Hospital
        • Principal Investigator:
          • Senthil Senniappan
        • Contact:
          • Phone Number: (447) 971-6250
  • United States
    • California
      • Ventura, California, United States, 93003-5369
        • Not yet recruiting
        • Carey Chronis MD Pediatric, Infant and Adolescent Medicine
        • Principal Investigator:
          • Carey Chronis
        • Contact:
          • Phone Number: 805-642-4704
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Not yet recruiting
        • Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
        • Principal Investigator:
          • Ania Jastreboff
        • Contact:
          • Phone Number: ania.jastreboff@yale.edu
      • Stamford, Connecticut, United States, 06905
        • Not yet recruiting
        • Stamford Therapeutics Consortium
        • Principal Investigator:
          • David Radin
        • Contact:
          • Phone Number: 727-544-4842
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Not yet recruiting
        • Children's Healthcare of Atlanta - Center for Advanced Pediatrics
        • Principal Investigator:
          • Daniel Hsia
        • Contact:
          • Phone Number: 404-712-4731
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Ann and Robert Lurie Children's Hospital of Chicago
        • Principal Investigator:
          • Justin Ryder
        • Contact:
          • Phone Number: 312-503-1499
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Not yet recruiting
        • Velocity Clinical Research
        • Principal Investigator:
          • Jibran Atwi
        • Contact:
          • Phone Number: 337-519-4742
    • Mississippi
      • Gulfport, Mississippi, United States, 39503-2637
        • Not yet recruiting
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
        • Principal Investigator:
          • Paul Matherne
        • Contact:
          • Phone Number: 228-206-1283
    • Missouri
      • St Louis, Missouri, United States, 63141-7068
        • Not yet recruiting
        • Sundance Clinical Research
        • Contact:
          • Phone Number: 314-567-3377
        • Principal Investigator:
          • Delores Chantal Dotson
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Not yet recruiting
        • Velocity Clinical Research
        • Contact:
          • Phone Number: 402-933-6500
        • Principal Investigator:
          • Brandon Essink
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Lucas Research, Inc
        • Principal Investigator:
          • Kathryn Lucas
        • Contact:
          • Phone Number: 252-222-5700
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Not yet recruiting
        • UPMC Children's Hospital of Pittsburgh
        • Principal Investigator:
          • Silva Arslanian
        • Contact:
          • Phone Number: 412-692-6935
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Not yet recruiting
        • Vanderbilt Health One Hundred Oaks
        • Principal Investigator:
          • Gitanjali Srivastava
        • Contact:
          • Phone Number: 615-322-6000
    • Texas
      • Houston, Texas, United States, 77065
        • Not yet recruiting
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
        • Principal Investigator:
          • Kashif Ali
        • Contact:
          • Phone Number: 281-517-0550
      • Houston, Texas, United States, 77071-1008
        • Not yet recruiting
        • La Providence Pediatrics Clinic - Chemidox Clinical Trials
        • Contact:
          • Phone Number: 833-324-3643
        • Principal Investigator:
          • Ifeyinwa Onwudiwe
      • Tomball, Texas, United States, 77375-3332
        • Not yet recruiting
        • Martin Diagnostic Clinic
        • Contact:
          • Phone Number: 281-517-0550
        • Principal Investigator:
          • Vicki Miller
    • Utah
      • West Jordan, Utah, United States, 84088
        • Not yet recruiting
        • Velocity Clinical Research, Salt Lake City
        • Contact:
          • Phone Number: 801-542-8190
        • Principal Investigator:
          • Barbara Rizzardi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orforglipron (ISA PW01)
Participants will receive orforglipron or placebo orally. Each ISA will detail the intervention specific.
Drug: Orforglipron
Administered orally. ISA specific interventions will be listed in the ISA.
Other Names:
  • LY3502970
Drug: Placebo
Administered orally. ISA specific interventions will be listed in the ISA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Allocated to Each ISA
Time Frame: Baseline to Week 72
Baseline to Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

November 1, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18865
  • J4M-MC-PWMP (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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