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Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)

150 patients around the world

Available in Mexico, United States

Eli Lilly and Company

4Research sites

150Patients around the world

This study is for people with

Obesity

To 11 Years

All Gender

: J4M-MC-PW02.
Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive).
Have.
A body weight of ≥ 40 kilograms (kg) (88 pounds), and.
Been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart.
J4M-MC-PWMP.
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]).

: J4M-MC-PW02.
Have a history of.
Proliferative diabetic retinopathy.
Diabetic macular edema, or.
Nonproliferative diabetic retinopathy that requires acute treatment.
J4M-MC-PWMP.
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 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.

Panamerican Clinical Research S.A. de C.V - Guadalajara

Guadalajara, 44670

Centro de Investigación Farmacológica del Bajío, S.C.

Av Paseo del Moral 419, Jardines del Moral, 37160 León, Guanajuato, México

CHRISTUS Centro de Excelencia en Investigación - CEI (Obispado)

Miguel Hidalgo y Costilla 2525, Obispado, 64060 Monterrey, N.L.

PanAmerican Clinical Research - Querétaro

Av. Antea 1032, Jurica, 76100 Santiago de Querétaro, Qro., Mexico

SponsorEli Lilly and Company

Study typeInterventional

Conditions

Obesity

Requirements

To 11 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT07817875