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Recruiting Phase 3 NCT06672549

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

Phase 3 – large-scale trial before approval
Conditions: Obesity Overweight

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Orforglipron
DRUG
Placebo
DRUG
Locations 50
Brazil (3)
L2IP - Instituto de Pesquisas Clínicas
Brasília
NOT_YET_RECRUITING
Hospital Universitario de Caxias do Sul
Caxias do Sul
NOT_YET_RECRUITING
CPQuali Pesquisa Clínica Sao Paulo
São Paulo
NOT_YET_RECRUITING
Israel (3)
Yitzhak Shamir Medical Center
Beer Yaacov
NOT_YET_RECRUITING
Shaare Zedek Medical Center
Jerusalem
NOT_YET_RECRUITING
Chaim Sheba Medical Center
Ramat Gan
NOT_YET_RECRUITING
Italy (4)
Azienda Ospedaliero Universitaria Meyer
Florence
NOT_YET_RECRUITING
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara
NOT_YET_RECRUITING
Ospedale Pediatrico Bambino Gesù
Roma
NOT_YET_RECRUITING
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona
NOT_YET_RECRUITING
Japan (9)
Saitama Medical University Hospital
Iruma-Gun
NOT_YET_RECRUITING
Isesaki Municipal Hospital
Isesaki-shi
NOT_YET_RECRUITING
University Hospital,Kyoto Prefectural University of Medicine
Kyoto
NOT_YET_RECRUITING
Tokyo Medical Center
Meguro-Ku
NOT_YET_RECRUITING
Shiga General Hospital
Moriyama
NOT_YET_RECRUITING
Nara Prefecture General Medical Center
Nara
NOT_YET_RECRUITING
Osaka City General Hospital
Osaka
NOT_YET_RECRUITING
Sagaekiminami Clinic
Saga
NOT_YET_RECRUITING
Shikoku Medical Center for Children and Adults
Zentsujichó
NOT_YET_RECRUITING
Mexico (4)
Centro Para el Desarrollo de la Medicina y de Asistencia Especializada SC
Culiacán
NOT_YET_RECRUITING
PanAmerican Clinical Research - Guadalajara
Guadalajara
NOT_YET_RECRUITING
Innovacion y Desarrollo de Estrategias en Salud SA de CV
Mexico City
NOT_YET_RECRUITING
Hospital Angeles Puebla
Puebla City
NOT_YET_RECRUITING
Poland (4)
Krakowskie Centrum Medyczne
Krakow
NOT_YET_RECRUITING
Instytut Diabetologii
Warsaw
NOT_YET_RECRUITING
FutureMeds - Targowek
Warsaw
NOT_YET_RECRUITING
FutureMeds sp. z o. o.
Wroclaw
NOT_YET_RECRUITING
United Kingdom (7)
Barnsley Hospital NHS Foundation Trust
Barnsley
NOT_YET_RECRUITING
Bristol Royal Hospital for Children
Bristol
NOT_YET_RECRUITING
Addenbrookes Hospital
Cambridge
NOT_YET_RECRUITING
Ninewells Hospital
Dundee
NOT_YET_RECRUITING
Northwick Park Hospital
Harrow
NOT_YET_RECRUITING
Hull Royal Infirmary - MAIN
Hull
NOT_YET_RECRUITING
Alder Hey Children's Hospital
Liverpool
NOT_YET_RECRUITING
United States (16)
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta , Georgia
NOT_YET_RECRUITING
Ann and Robert Lurie Children's Hospital of Chicago
Chicago , Illinois
NOT_YET_RECRUITING
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Gulfport , Mississippi
NOT_YET_RECRUITING
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Houston , Texas
NOT_YET_RECRUITING
La Providence Pediatrics Clinic - Chemidox Clinical Trials
Houston , Texas
NOT_YET_RECRUITING
Velocity Clinical Research
Lafayette , Louisiana
NOT_YET_RECRUITING
Lucas Research, Inc
Morehead City , North Carolina
Vanderbilt Health One Hundred Oaks
Nashville , Tennessee
NOT_YET_RECRUITING
Yale School of Medicine - Yale Diabetes Center (YDC)) Trials
New Haven , Connecticut
NOT_YET_RECRUITING
Velocity Clinical Research
Omaha , Nebraska
NOT_YET_RECRUITING
UPMC Children's Hospital of Pittsburgh
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
Sundance Clinical Research
St Louis , Missouri
NOT_YET_RECRUITING
Stamford Therapeutics Consortium
Stamford , Connecticut
NOT_YET_RECRUITING
Martin Diagnostic Clinic
Tomball , Texas
NOT_YET_RECRUITING
Carey Chronis MD Pediatric, Infant and Adolescent Medicine
Ventura , California
NOT_YET_RECRUITING
Velocity Clinical Research, Salt Lake City
West Jordan , Utah
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Years
Maximum age
17 Years
Healthy volunteers
No
Start date
18.11.2024
Completion date
01.03.2027
Registry ID
NCT06672549
Source
clinicaltrials.gov
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