Last updated 13 days ago

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

125 patients around the world

Available in Brazil, Mexico

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.

Eli Lilly and Company

7Research sites

125Patients around the world

This study is for people with

Obesity

Requirements for the patient

To 17 Years

All Gender

Medical requirements

: 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])
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).

: 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.
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.

Sites

CPQuali Pesquisa Clínica

Avenida Angélica, 916 Conjunto 506 - São Paulo 01228-000

L2IP Instituto de Pesquisas Clínicas

SGAS 613, Conj. E Bloco A , Sala 06 - Subsolo , Asa Sul - Brasília/DF, CEP: 70.200-730

Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)

R. Francisco Getúlio Vargas, 1130 - 315 - Petrópolis, Caxias do Sul - RS, 95070-560, Brazil

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Campus Universitário S/N, Bloco G Subsolo II, Monte Alegre, Ribeirão Preto, Sao Paulo

Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada, S.C. - SINACOR

Río Choix 922, Antonio Rosales, 80230 Culiacán Rosales, Sin., Mexico

Hospital Ángeles Puebla

Av. Kepler 2143, Reserva Territorial Atlixcáyotl, Puebla

Panamerican Clinical Research S.A. de C.V

Guadalajara, 44670

StudyADVANCE

SponsorEli Lilly and Company

Study typeInterventional

Conditions

Obesity

Requirements

To 17 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06672549