RecruitingPhase 3NCT06672549

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

Sponsor

Eli Lilly and Company

Enrollment

125 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity Overweight

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.

Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Orforglipron and a drug called Placebo for people with obesity and overweight. The study is currently recruiting participants at 50 locations. People eligible for this study include aged 6 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOrforglipron

Administered orally. ISA specific interventions will be listed in the ISA.

DRUGPlacebo

Administered orally. ISA specific interventions will be listed in the ISA.

Locations(50)

Carey Chronis MD Pediatric, Infant and Adolescent Medicine

Ventura, California, United States

Yale School of Medicine - Yale Diabetes Center (YDC)) Trials

New Haven, Connecticut, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, United States

Ann and Robert Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Velocity Clinical Research

Lafayette, Louisiana, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Gulfport, Mississippi, United States

Sundance Clinical Research

St Louis, Missouri, United States

Velocity Clinical Research

Omaha, Nebraska, United States

Lucas Research, Inc

Morehead City, North Carolina, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt Health One Hundred Oaks

Nashville, Tennessee, United States

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Houston, Texas, United States

La Providence Pediatrics Clinic - Chemidox Clinical Trials

Houston, Texas, United States

Martin Diagnostic Clinic

Tomball, Texas, United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States

L2IP - Instituto de Pesquisas Clínicas

Brasília, Brazil

Hospital Universitario de Caxias do Sul

Caxias do Sul, Brazil

CPQuali Pesquisa Clínica Sao Paulo

São Paulo, Brazil

Yitzhak Shamir Medical Center

Beer Yaacov, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Azienda Ospedaliero Universitaria Meyer

Florence, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, Italy

Saitama Medical University Hospital

Iruma-Gun, Japan

Isesaki Municipal Hospital

Isesaki-shi, Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Japan

Tokyo Medical Center

Meguro-Ku, Japan

Shiga General Hospital

Moriyama, Japan

Nara Prefecture General Medical Center

Nara, Japan

Osaka City General Hospital

Osaka, Japan

Sagaekiminami Clinic

Saga, Japan

Shikoku Medical Center for Children and Adults

Zentsujichó, Japan

Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC

Culiacán, Mexico

PanAmerican Clinical Research - Guadalajara

Guadalajara, Mexico

Innovacion y Desarrollo de Estrategias en Salud SA de CV

Mexico City, Mexico

Hospital Angeles Puebla

Puebla City, Mexico

Krakowskie Centrum Medyczne

Krakow, Poland

Instytut Diabetologii

Warsaw, Poland

FutureMeds - Targowek

Warsaw, Poland

FutureMeds sp. z o. o.

Wroclaw, Poland

Barnsley Hospital NHS Foundation Trust

Barnsley, United Kingdom

Bristol Royal Hospital for Children

Bristol, United Kingdom

Addenbrookes Hospital

Cambridge, United Kingdom

Ninewells Hospital

Dundee, United Kingdom

Northwick Park Hospital

Harrow, United Kingdom

Hull Royal Infirmary - MAIN

Hull, United Kingdom

Alder Hey Children's Hospital

Liverpool, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06672549

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