Last updated 26 days ago

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

300 patients around the world

Available in Puerto Rico, Spain, Argentina, United States, Mexico

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.

Eli Lilly and Company

11Research sites

300Patients around the world

This study is for people with

Obesity

Requirements for the patient

To 17 Years

All Gender

Medical requirements

: Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).

: Have undergone or plan to undergo a 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 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 type 2 diabetes or have a HbA1c > 6.4% at screening.
Have a history of chronic or acute pancreatitis.
Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

Sites

CEDIMBA - DIM Clínica Privada - Buenos Aires

Recruiting

Belgrano 136, Ramos Mejia, Buenos Aires.

Centro Médico Maffei - CABA, Buenos Aires

Recruiting

Av. Cerviño 3375, CABA, Buenos Aires

Centro de Investigaciones Médicas Tucumán

Recruiting

Lavalle 506, T4000 San Miguel de Tucumán, Tucumán, Argentina

Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires

Recruiting

Viamonte 2278, C1056ABJ Cdad. Autónoma de Buenos Aires, Argentina

Investigaciones Médicas IMOBA SRL

Recruiting

Viamonte 2168, C1056ABH Cdad. Autónoma de Buenos Aires, Argentina

Fundación Respirar

Recruiting

Av. Cabildo 1548, CABA, Buenos Aires

Investigación Clínica Aplicada S.R.L.

Recruiting

CERVIÑO 3375 1º 12 – Palermo, CABA. CP 1425

Centro de Investigación Médica de Occidente, S.C. - Zapopan

Recruiting

Av. Ludwig Van Beethoven 5612, La Estancia, Zapopan, Jalisco

CHRISTUS Centro de Excelencia en Investigación - CEI (Obispado)

Recruiting

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

Clínica García Flores

Recruiting

1a Avenida 507, Cumbres 1º Sector, 64610 Monterrey, N.L., Mexico

StudySURMOUNT-ADOLESCENTS-2

SponsorEli Lilly and Company

Study typeInterventional

Conditions

Obesity

Requirements

To 17 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06439277