Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)
Status: Recruiting
Location: See all (75) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:
• 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).
Locations
United States
California
Children's Hospital Los Angeles
ACTIVE_NOT_RECRUITING
Los Angeles
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
ACTIVE_NOT_RECRUITING
Sacramento
Delaware
Nemours Children's Health - Delaware
ACTIVE_NOT_RECRUITING
Wilmington
Georgia
CenExel iResearch, LLC
COMPLETED
Decatur
Idaho
Medical Research Partners
ACTIVE_NOT_RECRUITING
Ammon
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
ACTIVE_NOT_RECRUITING
Chicago
Indiana
Indiana University Health University Hospital
ACTIVE_NOT_RECRUITING
Indianapolis
New York
UBMD Pediatrics
ACTIVE_NOT_RECRUITING
Buffalo
SUNY Upstate Medical University
ACTIVE_NOT_RECRUITING
Syracuse
Texas
Driscoll Children's Hospital
ACTIVE_NOT_RECRUITING
Corpus Christi
Epic Medical Research - DeSoto
ACTIVE_NOT_RECRUITING
Desoto
Valley Institute of Research - Fort Worth
ACTIVE_NOT_RECRUITING
Fort Worth
Consano Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Shavano Park
Texas Valley Clinical Research
ACTIVE_NOT_RECRUITING
Weslaco
Utah
Alliance for Multispecialty Research, LLC
COMPLETED
Layton
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
RECRUITING
Buenos Aires
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
RECRUITING
Buenos Aires
Fundación Respirar
RECRUITING
Buenos Aires
Investigaciones Medicas Imoba Srl
RECRUITING
Buenos Aires
DIM Clínica Privada
RECRUITING
Ramos Mejía
Centro de Investigaciones Médicas Tucuman
RECRUITING
San M. De Tucuman
Australia
Nightingale Research
RECRUITING
Adelaide
Cornerstone Dermatology
RECRUITING
Coorparoo
Hunter Medical Research Institute
RECRUITING
Newcastle
Perth Children's Hospital
RECRUITING
Perth
University of Sydney - Charles Perkins Centre
RECRUITING
Sydney
The Children's Hospital at Westmead
RECRUITING
Westmead
Canada
Alberta Children's Hospital
RECRUITING
Calgary
Premier Clinical Trial Network
RECRUITING
Hamilton
Winterberry Research Inc.
RECRUITING
Hamilton
Bluewater Clinical Research Group Inc.
COMPLETED
Sarnia
France
Centre Hospitalier Universitaire d'Angers
ACTIVE_NOT_RECRUITING
Angers
Hospices Civils de Lyon - Hopital Louis Pradel
ACTIVE_NOT_RECRUITING
Bron
Hôpital Jeanne de Flandre
ACTIVE_NOT_RECRUITING
Lille
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
ACTIVE_NOT_RECRUITING
Marseille
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
ACTIVE_NOT_RECRUITING
Paris
Hôpital Armand Trousseau
ACTIVE_NOT_RECRUITING
Paris
CHU de Toulouse - Hôpital des Enfants
COMPLETED
Toulouse
Germany
Universitaetsklinikum Koeln
ACTIVE_NOT_RECRUITING
Cologne
Universitätsklinikum Leipzig
ACTIVE_NOT_RECRUITING
Leipzig
Universitaetsklinikum Ulm
ACTIVE_NOT_RECRUITING
Ulm
Israel
Emek Medical Center
ACTIVE_NOT_RECRUITING
Afula
Yitzhak Shamir Medical Center
COMPLETED
Beer Yaacov
Soroka Medical Center
ACTIVE_NOT_RECRUITING
Beersheba
Carmel Hospital
ACTIVE_NOT_RECRUITING
Haifa
Rambam Health Care Campus
ACTIVE_NOT_RECRUITING
Haifa
Shaare Zedek Medical Center
COMPLETED
Jerusalem
Meir Medical Center
ACTIVE_NOT_RECRUITING
Kfar Saba
Schneider Children's Medical Center
ACTIVE_NOT_RECRUITING
Petah Tikva
Sheba Medical Center
ACTIVE_NOT_RECRUITING
Ramat Gan
Mexico
Centro de Atención e Investigación Clínica
RECRUITING
Aguascalientes
Centro de Investigacion Medica de Occidente, S.C.
RECRUITING
Guadalajara
Christus - Latam Hub Center of Excellence and Innovation S.C.
RECRUITING
Monterrey
Clínica García Flores SC
RECRUITING
Monterrey
Consultorio Médico de Endocrinología y Pediatría
RECRUITING
Puebla City
Puerto Rico
University Pediatric Hospital
COMPLETED
San Juan
Spain
Hospital Universitari Vall d'Hebron
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario Reina Sofia
ACTIVE_NOT_RECRUITING
Córdoba
Hospital Infantil Universitario Niño Jesús
ACTIVE_NOT_RECRUITING
Madrid
H.R.U Málaga - Hospital General
ACTIVE_NOT_RECRUITING
Málaga
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
ACTIVE_NOT_RECRUITING
Valencia
Taiwan
China Medical University Hospital
ACTIVE_NOT_RECRUITING
Taichung
National Cheng Kung University Hospital
ACTIVE_NOT_RECRUITING
Tainan
National Taiwan University Hospital
COMPLETED
Taipei
Chang Gung Medical Foundation-Linkou Branch
ACTIVE_NOT_RECRUITING
Taoyuan District
United Kingdom
Addenbrooke's Hospital
RECRUITING
Cambridge
Royal Hospital for Children
RECRUITING
Glagow
Leeds General Infirmary
RECRUITING
Leeds
Leicester Royal Infirmary
RECRUITING
Leicester
Alder Hey Children's Hospital
RECRUITING
Liverpool
Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital
RECRUITING
London
Royal Victoria Infirmary
RECRUITING
Newcastle Upon Tyne
Sheffield Children's Hospital
RECRUITING
Sheffield
Southampton General Hospital
RECRUITING
Southampton
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-06-03
Estimated Completion Date: 2030-12
Participants
Target number of participants: 300
Treatments
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC).
Placebo_comparator: Placebo
Participants will receive placebo SC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company