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