Last updated 8 days ago
A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities
125 patients around the world
Available in Brazil, United States, Mexico
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
- J4M-MC-PWMPHave 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]).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).
- Prepubertal (Tanner stage 1).Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kilograms (kg) (11 pounds) within 90 days before screening.Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to, gastric bypass.gastric bypassHave undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to, sleeve gastrectomy.Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to, restrictive bariatric surgery, such as Lap-Band® gastric banding.Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to, 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 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
L2IP Instituto de Pesquisas Clínicas
Instituto de Pesquisas em Saúde - Fundação Universidade de Caxias do Sul (IPS/FUCS)
Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada, S.C. - SINACOR
Panamerican Clinical Research S.A. de C.V
Innovación y Desarrollo en Ciencias de la Salud - IDeCSa
Hospital Ángeles Puebla
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Obesity
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06672939
