A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
NCT ID: NCT06439277
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2024-06-03
2030-12-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tirzepatide
Participants will receive tirzepatide subcutaneously (SC).
Tirzepatide
Administered SC
Placebo
Participants will receive placebo SC.
Placebo
Administered SC
Interventions
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Tirzepatide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Central Research Associates
Birmingham, Alabama, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, United States
Nemours Children's Health - Delaware
Wilmington, Delaware, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
Medical Research Partners
Ammon, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
UBMD Pediatrics
Buffalo, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Epic Medical Research - DeSoto
DeSoto, Texas, United States
Valley Institute of Research - Fort Worth
Fort Worth, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Texas Valley Clinical Research
Weslaco, Texas, United States
Alliance for Multispecialty Research, LLC
Layton, Utah, United States
Investigaciones Medicas Imoba Srl
Buenos Aires, , Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, , Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, , Argentina
Fundación Respirar
Buenos Aires, , Argentina
DIM Clínica Privada
Ramos Mejía, , Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, , Argentina
Nightingale Research
Adelaide, , Australia
Cornerstone Dermatology
Coorparoo, , Australia
Hunter Medical Research Institute
Newcastle, , Australia
Perth Children's Hospital
Perth, , Australia
University of Sydney - Charles Perkins Centre
Sydney, , Australia
The Children's Hospital at Westmead
Westmead, , Australia
Kids Clinic
Ajax, , Canada
Alberta Children's Hospital
Calgary, , Canada
Winterberry Research Inc.
Hamilton, , Canada
Premier Clinical Trial Network
Hamilton, , Canada
London Health Sciences Centre - Verspeeten Family Cancer Centre
London, , Canada
Bluewater Clinical Research Group Inc.
Sarnia, , Canada
Centre Hospitalier Universitaire d'Angers
Angers, , France
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, , France
Hôpital Jeanne de Flandre
Lille, , France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, , France
Hôpital Armand Trousseau
Paris, , France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
Paris, , France
CHU de Toulouse - Hôpital des Enfants
Toulouse, , France
Universitaetsklinikum Koeln
Cologne, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Emek Medical Center
Afula, , Israel
Yitzhak Shamir Medical Center
Beer Yaacov, , Israel
Soroka Medical Center
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Carmel Hospital
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Centro de Atención e Investigación Clínica
Aguascalientes, , Mexico
Centro de Investigacion Medica de Occidente, S.C.
Guadalajara, , Mexico
Christus - Latam Hub Center of Excellence and Innovation S.C.
Monterrey, , Mexico
Clínica García Flores SC
Monterrey, , Mexico
Consultorio Médico de Endocrinología y Pediatría
Puebla City, , Mexico
University Pediatric Hospital
San Juan, , Puerto Rico
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
H.R.U Málaga - Hospital General
Málaga, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Addenbrooke's Hospital
Cambridge, , United Kingdom
Royal Hospital for Children
Glagow, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Alder Hey Children's Hospital
Liverpool, , United Kingdom
Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
Phone: 1-317-615-4559
Email: [email protected]
Physicians interested in becoming principal investigators please contact
Role: CONTACT
Email: [email protected]
Facility Contacts
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Related Links
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A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Other Identifiers
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I8F-MC-GPIX
Identifier Type: OTHER
Identifier Source: secondary_id
18832
Identifier Type: -
Identifier Source: org_study_id