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NCT06672549PHASE3Recruiting

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

Eli Lilly and Company

Start Date

11/18/2024

Completion Date

3/1/2027

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.

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.

Eligibility Criteria

Age Range: 6 years to 17 years

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.

Interventions

DRUG

Orforglipron

DRUG

Placebo

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Conditions

ObesityOverweight

Locations

University of Arizona

Tucson, Arizona 85721

United States

Loma Linda University School of Medicine

Loma Linda, California 92354

United States

Childrens Hospital of Los Angeles

Los Angeles, California 90027

United States

UCLA Mattel Children's Hospital

Los Angeles, California 90095

United States

Children's Hospital of Orange County - Orange

Orange, California 92868

United States

Carey Chronis MD Pediatric, Infant and Adolescent Medicine

Ventura, California 93003-5369

United States

Children's Hospital Colorado

Colorado Springs, Colorado 80920-7843

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

William A. Shands Hospital at the University of Florida

Gainesville, Florida 32610-3003

United States

Florida Hospital- Center for Pediatric Research

Orlando, Florida 32803

United States

Nemours Children's Health

Orlando, Florida 32827

United States

All Childrens Hospital

St. Petersburg, Florida 33701

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

University of Illinois at Chicago

Chicago, Illinois 60612

United States

Riley Hospital for Children

Indianapolis, Indiana 46202

United States

Norton Children's Endocrinology

Louisville, Kentucky 40202

United States

Velocity Clinical Research

Lafayette, Louisiana 70508

United States

Johns Hopkins Children's Center

Baltimore, Maryland 21287

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Helen Devos Childrens' Hospital - PIN

Grand Rapids, Michigan 49503-2560

United States

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota 55454

United States

Mayo Clinic - PIN

Rochester, Minnesota 55905-0001

United States

Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center

Saint Paul, Minnesota 55102-3354

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

Omaha Childrens Hospital

Omaha, Nebraska 68114

United States

Velocity Clinical Research

Omaha, Nebraska 68134

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

UBMD Pediatrics

Buffalo, New York 14203

United States

UNC Children's Hospital

Chapel Hill, North Carolina 27514

United States

Duke Children's Primary Care

Durham, North Carolina 27704-2102

United States

Lucas Research, Inc

Morehead City, North Carolina 28557

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15224

United States

Coastal Pediatric Associates

Charleston, South Carolina 29414

United States

Medical University of South Carolina Children Hospital - PIN

Charleston, South Carolina 29425

United States

Vanderbilt Health One Hundred Oaks

Nashville, Tennessee 37204

United States

Dell Children's Medical Center - PIN

Austin, Texas 78723-3079

United States

Driscoll Children's Hospital

Corpus Christi, Texas 78411

United States

McGovern Medical School

Houston, Texas 77030-1521

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

VCU Health - Center for Endocrinology Diabetes and Metabolism

Richmond, Virginia 23229-3156

United States

Seattle Children's Research Institute - Hughes Building - PIN

Seattle, Washington 98101

United States

MultiCare Health System - Mary Bridge Children's Health Center

Tacoma, Washington 98405

United States

UZ Brussel

Brussels, 1090

Belgium

Cliniques Universitaires Saint-Luc - PPDS

Brussels, 1200

Belgium

UZ Leuven

Leuven, 3000

Belgium

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 Ospedaliera Universitaria Policlinico de Modena

Modena, 41124

Italy

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100

Italy

Azienda Ospedaliero Universitaria di Parma

Parma, 43126

Italy

Ospedale Pediatrico Bambino Gesù

Roma, 165

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

Hospital da Luz Lisboa

Lisbon, 1500-650

Portugal

Centro Materno Infantil do Norte

Porto, 4050-651

Portugal

Hospital CUF Porto

Porto, 4100-180

Portugal

Seoul National University Bundang Hospital

Seongnam-si, 13620

South Korea

Hanyang University Seoul Hospital

Seoul, 04763

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Asan Medical Center

Seoul, 5505

South Korea

Hospital Universitario Vall d'Hebron

Barcelona, 08035

Spain

Hospital Infantil Universitario Niño Jesús

Madrid, 28009

Spain

Hospital Regional Universitario de Malaga - Hospital Materno-Infantil

Málaga, 29011

Spain

Corporacio Sanitaria Parc Tauli

Sabadell, 8208

Spain

Instituto Hispalense de Pediatria

Seville, 41014

Spain

Hospital Universitario de Araba (HUA)- Hospital Txagorritxu

Vitoria-Gasteiz, 01009

Spain

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