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NCT06439277PHASE3Recruiting

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

Eli Lilly and Company

Start Date

6/3/2024

Completion Date

12/1/2030

Summary

The goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

Detailed Description

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.

Eligibility Criteria

Age Range: 12 years to 17 years

Inclusion Criteria: * 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). Exclusion Criteria: * 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

Interventions

DRUG

Tirzepatide

DRUG

Placebo

Interested in This Trial?

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Conditions

ObesityWeight Gain

Locations

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology

Sacramento, California 95821

United States

Nemours Children's Health - Delaware

Wilmington, Delaware 19803

United States

Medical Research Partners

Ammon, Idaho 83406

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

Indiana University Health University Hospital

Indianapolis, Indiana 46202

United States

UBMD Pediatrics

Buffalo, New York 14203

United States

SUNY Upstate Medical University

Syracuse, New York 13210

United States

Driscoll Children's Hospital

Corpus Christi, Texas 78411

United States

Epic Medical Research - DeSoto

DeSoto, Texas 75115

United States

Valley Institute of Research - Fort Worth

Fort Worth, Texas 76164

United States

Consano Clinical Research, LLC

Shavano Park, Texas 78231

United States

Texas Valley Clinical Research

Weslaco, Texas 78596

United States

Alliance for Multispecialty Research, LLC

Layton, Utah 84041

United States

Investigaciones Medicas Imoba Srl

Buenos Aires, C1056ABH

Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI

Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, C1425AGC

Argentina

Fundación Respirar

Buenos Aires, C1426ABP

Argentina

DIM Clínica Privada

Ramos Mejía, B1704ETD

Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, T4000AXL

Argentina

Nightingale Research

Adelaide, 5000

Australia

Cornerstone Dermatology

Coorparoo, 4151

Australia

Hunter Medical Research Institute

Newcastle, 2305

Australia

Perth Children's Hospital

Perth, 6009

Australia

University of Sydney - Charles Perkins Centre

Sydney, 2006

Australia

Alberta Children's Hospital

Calgary, T3B 6A8

Canada

Winterberry Research Inc.

Hamilton, L8J 0B6

Canada

Premier Clinical Trial Network

Hamilton, L8L5G4

Canada

Bluewater Clinical Research Group Inc.

Sarnia, N7T 4X3

Canada

Centre Hospitalier Universitaire d'Angers

Angers, 49933

France

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, 69677

France

Hôpital Jeanne de Flandre

Lille, 59000

France

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, 13385

France

Hôpital Armand Trousseau

Paris, 75012

France

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T

Paris, 75019

France

CHU de Toulouse - Hôpital des Enfants

Toulouse, 31059

France

Universitaetsklinikum Koeln

Cologne, 50937

Germany

Universitätsklinikum Leipzig

Leipzig, 04103

Germany

Universitaetsklinikum Ulm

Ulm, 89075

Germany

Emek Medical Center

Afula, 1834111

Israel

Yitzhak Shamir Medical Center

Beer Yaacov, 70300

Israel

Soroka Medical Center

Beersheba, 8410101

Israel

Rambam Health Care Campus

Haifa, 3109601

Israel

Carmel Hospital

Haifa, 3436212

Israel

Shaare Zedek Medical Center

Jerusalem, 9013102

Israel

Meir Medical Center

Kfar Saba, 4428164

Israel

Schneider Children's Medical Center

Petah Tikva, 4920235

Israel

Sheba Medical Center

Ramat Gan, 5262100

Israel

Centro de Atención e Investigación Clínica

Aguascalientes, 20129

Mexico

Centro de Investigacion Medica de Occidente, S.C.

Guadalajara, 44260

Mexico

Christus - Latam Hub Center of Excellence and Innovation S.C.

Monterrey, 64060

Mexico

Clínica García Flores SC

Monterrey, 64610

Mexico

Consultorio Médico de Endocrinología y Pediatría

Puebla City, 72190

Mexico

University Pediatric Hospital

San Juan, 00935

Puerto Rico

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Hospital Infantil Universitario Niño Jesús

Madrid, 28009

Spain

H.R.U Málaga - Hospital General

Málaga, 29011

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

China Medical University Hospital

Taichung, 404332

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

Addenbrooke's Hospital

Cambridge, CB2 0SL

United Kingdom

Royal Hospital for Children

Glagow, G51 4TF

United Kingdom

Leeds General Infirmary

Leeds, LS1 3EX

United Kingdom

Leicester Royal Infirmary

Leicester, LE1 5WW

United Kingdom

Alder Hey Children's Hospital

Liverpool, L14 5AB

United Kingdom

Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital

London, WC1E 6DB

United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4PL

United Kingdom

Sheffield Children's Hospital

Sheffield, S10 2TH

United Kingdom

Southampton General Hospital

Southampton, SO16 6YD

United Kingdom