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

Last updated: March 22, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Obesity

Treatment

Placebo

Tirzepatide

Clinical Study ID

NCT06439277
18832
I8F-MC-GPIX
  • Ages 12-17
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Have body mass index (BMI) equal to or above the 95th percentile for age and sex (onage and gender-specific growth chart for diagnosis of obesity) with at least 2 ofthe following predefined weight-related comorbidities: hypertension, prediabetes andhypertriglyceridemia.

  • 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 bya study participant (when applicable).

Exclusion

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 inbody weight greater than 5 kg (11 lbs) within 90 days before screening irrespectiveof 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 multipleendocrine neoplasia syndrome type 2

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 03, 2024
Estimated Completion Date:
December 31, 2030

Study 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.

Connect with a study center

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires C1425AGC
    Argentina

    Site Not Available

  • Centro Medico Privado de Reumatologia

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucuman

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Active - Recruiting

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425AGC
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI
    Argentina

    Active - Recruiting

  • Fundación Respirar

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, C1056ABH
    Argentina

    Active - Recruiting

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires 3435910, C1425AGC
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires 3435910, C1056ABI
    Argentina

    Active - Recruiting

  • Fundación Respirar

    Buenos Aires 3435910, C1426ABP
    Argentina

    Active - Recruiting

  • Investigaciones Medicas Imoba Srl

    Buenos Aires 3435910, C1056ABH
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

    Site Not Available

  • DIM Clínica Privada

    Ramos Mejía, B1704ETD
    Argentina

    Active - Recruiting

  • DIM Clínica Privada

    Ramos Mejía 3429617, B1704ETD
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucuman

    SAN M. de Tucuman, T4000AXL
    Argentina

    Active - Recruiting

  • Nightingale Research

    Adelaide, 5000
    Australia

    Active - Recruiting

  • Nightingale Research

    Adelaide 2078025, 5000
    Australia

    Site Not Available

  • Cornerstone Dermatology

    Coorparoo, 4151
    Australia

    Active - Recruiting

  • Cornerstone Dermatology

    Coorparoo 2170435, 4151
    Australia

    Site Not Available

  • Hunter Medical Research Institute

    Newcastle, 2305
    Australia

    Active - Recruiting

  • Hunter Medical Research Institute

    Newcastle 2155472, 2305
    Australia

    Site Not Available

  • Perth Children's Hospital

    Perth, 6009
    Australia

    Active - Recruiting

  • Perth Children's Hospital

    Perth 2063523, 6009
    Australia

    Site Not Available

  • University of Sydney - Charles Perkins Centre

    Sydney, 2006
    Australia

    Active - Recruiting

  • University of Sydney - Charles Perkins Centre

    Sydney 2147714, 2006
    Australia

    Site Not Available

  • The Children's Hospital at Westmead

    Westmead, 2145
    Australia

    Active - Recruiting

  • The Children's Hospital at Westmead

    Westmead 2143973, 2145
    Australia

    Site Not Available

  • Alberta Children's Hospital Loc. 1

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • Kids Clinic

    Ajax, Ontario L1Z 0M1
    Canada

    Site Not Available

  • Dr. Steven V. Zizzo Medicine Professional Corporation

    Hamilton, Ontario L8J 0B6
    Canada

    Active - Recruiting

  • Dr. Steven V. Zizzo Research Professional Corporation

    Hamilton, Ontario L8J 0B6
    Canada

    Active - Recruiting

  • Hamilton Medical Research Group

    Hamilton, Ontario L8M 1K7
    Canada

    Active - Recruiting

  • Maison de Santé Prévention

    Montreal, Quebec H2J 1K1
    Canada

    Site Not Available

  • McGill University Health Centre

    Montréal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Kids Clinic

    Ajax 5882873, L1Z 0M1
    Canada

    Site Not Available

  • Alberta Children's Hospital

    Calgary, T3B 6A8
    Canada

    Active - Recruiting

  • Alberta Children's Hospital

    Calgary 5913490, T3B 6A8
    Canada

    Site Not Available

  • Premier Clinical Trial Network

    Hamilton, L8L5G4
    Canada

    Active - Recruiting

  • Winterberry Research Inc.

    Hamilton, L8J 0B6
    Canada

    Active - Recruiting

  • Premier Clinical Trial Network

    Hamilton 5969782, L8L5G4
    Canada

    Site Not Available

  • Winterberry Research Inc.

    Hamilton 5969782, L8J 0B6
    Canada

    Active - Recruiting

  • London Health Sciences Centre - Verspeeten Family Cancer Centre

    London 6058560, N6A 5W9
    Canada

    Site Not Available

  • Bluewater Clinical Research Group Inc.

    Sarnia, N7T 4X3
    Canada

    Completed

  • Bluewater Clinical Research Group Inc.

    Sarnia 6141190, N7T 4X3
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933
    France

    Site Not Available

  • Centre Hospitalier Universitaire d'Angers

    Angers 3037656, 49933
    France

    Site Not Available

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Bron 3029931, 69677
    France

    Site Not Available

  • Hôpital Jeanne de Flandre

    Lille, 59000
    France

    Site Not Available

  • Hôpital Jeanne de Flandre

    Lille 2998324, 59000
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, 13385
    France

    Site Not Available

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille 2995469, 13385
    France

    Site Not Available

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

    Paris, 75019
    France

    Site Not Available

  • Hôpital Armand Trousseau

    Paris, 75012
    France

    Site Not Available

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

    Paris 2988507, 75019
    France

    Site Not Available

  • Hôpital Armand Trousseau

    Paris 2988507, 75012
    France

    Site Not Available

  • CHU de Toulouse - Hôpital des Enfants

    Toulouse, 31059
    France

    Completed

  • CHU de Toulouse - Hôpital des Enfants

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Klinik und Poliklinik für Kinder- und Jugendmedizin pädiatrische Endokrinologie und Diabetologie

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Köln, Nordrhein-Westfalen 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Cologne, 50937
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln

    Cologne 2886242, 50937
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig 2879139, 04103
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, 89075
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm 2820256, 89075
    Germany

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva, HaDarom 8410101
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah-Tikva, HaMerkaz 4920235
    Israel

    Site Not Available

  • Pediatrics Endocrinology

    Haifa, Ḥeifā 3436212
    Israel

    Site Not Available

  • Emek Medical Center

    Afula, 1834111
    Israel

    Site Not Available

  • Emek Medical Center

    Afula 295740, 1834111
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Beer Yaacov, 70300
    Israel

    Completed

  • Soroka Medical Center

    Beersheba, 8410101
    Israel

    Site Not Available

  • Soroka Medical Center

    Beersheba 295530, 8410101
    Israel

    Site Not Available

  • Carmel Hospital

    Haifa, 3436212
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Site Not Available

  • Carmel Hospital

    Haifa 294801, 3436212
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9013102
    Israel

    Completed

  • Shaare Zedek Medical Center

    Jerusalem 281184, 9013102
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba, 4428164
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar Saba 294514, 4428164
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah Tikva, 4920235
    Israel

    Site Not Available

  • Schneider Children's Medical Center

    Petah Tikva 293918, 4920235
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 5262100
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan 293788, 5262100
    Israel

    Site Not Available

  • Centro de Investigacion Medica de Occidente, S.C.

    Zapopan, Jalisco 45116
    Mexico

    Site Not Available

  • Centro de Atención e Investigación Clínica

    Aguascalientes, 20129
    Mexico

    Active - Recruiting

  • Centro de Atención e Investigación Clínica

    Aguascalientes 4019233, 20129
    Mexico

    Site Not Available

  • Centro de Investigacion Medica de Occidente, S.C.

    Guadalajara, 44260
    Mexico

    Active - Recruiting

  • Centro de Investigacion Medica de Occidente, S.C.

    Guadalajara 4005539, 44260
    Mexico

    Site Not Available

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

    Monterrey, 64060
    Mexico

    Active - Recruiting

  • Clínica García Flores SC

    Monterrey, 64610
    Mexico

    Active - Recruiting

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

    Monterrey 3995465, 64060
    Mexico

    Active - Recruiting

  • Clínica García Flores SC

    Monterrey 3995465, 64610
    Mexico

    Site Not Available

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla, 72190
    Mexico

    Site Not Available

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla City, 72190
    Mexico

    Active - Recruiting

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla City 3521081, 72190
    Mexico

    Site Not Available

  • University Pediatric Hospital

    San Juan, 00935
    Puerto Rico

    Completed

  • University Pediatric Hospital

    San Juan 4568127, 00935
    Puerto Rico

    Site Not Available

  • Hospital Universitario Reina Sofia

    Cordoba, Andalucía 14004
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Hospital Infantil Universitario Niño Jesús

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Infantil Universitario Niño Jesús

    Madrid 3117735, 28009
    Spain

    Site Not Available

  • H.R.U Málaga - Hospital General

    Málaga, 29011
    Spain

    Site Not Available

  • Hospital Regional Universitario

    Málaga, 29011
    Spain

    Site Not Available

  • H.R.U Málaga - Hospital General

    Málaga 2514256, 29011
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

  • China Medical University Hospital

    Taichung, 404332
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung 1668399, 404332
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan 1668355, 704
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan City 1668355, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Completed

  • National Taiwan University Hospital

    Taipei 1668341, 10002
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan District, 333
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Bristol Royal Hospital for Children

    Bristol, Bristol, City Of BS2 8AE
    United Kingdom

    Site Not Available

  • Women's and Children's Division Research Unit

    Bristol, Bristol, City Of BS2 8AE
    United Kingdom

    Site Not Available

  • University Hospital Southampton

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, CB2 0SL
    United Kingdom

    Active - Recruiting

  • Addenbrooke's Hospital

    Cambridge 2653941, CB2 0SL
    United Kingdom

    Site Not Available

  • Royal Hospital for Children

    Glagow, G51 4TF
    United Kingdom

    Active - Recruiting

  • Leeds General Infirmary

    Leeds, LS1 3EX
    United Kingdom

    Active - Recruiting

  • Leeds General Infirmary

    Leeds 2644688, LS1 3EX
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary

    Leicester, LE1 5WW
    United Kingdom

    Active - Recruiting

  • Leicester Royal Infirmary

    Leicester 2644668, LE1 5WW
    United Kingdom

    Site Not Available

  • Alder Hey Children's Hospital

    Liverpool, L14 5AB
    United Kingdom

    Active - Recruiting

  • Alder Hey Children's Hospital

    Liverpool 2644210, L14 5AB
    United Kingdom

    Site Not Available

  • Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital

    London, WC1E 6DB
    United Kingdom

    Active - Recruiting

  • Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital

    London 2643743, WC1E 6DB
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4PL
    United Kingdom

    Active - Recruiting

  • Royal Victoria Infirmary

    Newcastle upon Tyne 2641673, NE1 4PL
    United Kingdom

    Site Not Available

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Sheffield 2638077, S10 2TH
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton 2637487, SO16 6YD
    United Kingdom

    Site Not Available

  • Central Research Associates

    Birmingham 4049979, Alabama 4829764 35205
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • Center Of Excellence in Diabetes and Endocrinology

    Sacramento, California 95821
    United States

    Active - Recruiting

  • Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology

    Sacramento, California 95821
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles 5368361, California 5332921 90027
    United States

    Site Not Available

  • Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology

    Sacramento 5389489, California 5332921 95821
    United States

    Site Not Available

  • Nemours Children's Health - Delaware

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Nemours Children's Health - Delaware

    Wilmington 4145381, Delaware 4142224 19803
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Completed

  • CenExel iResearch, LLC

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Medical Research Partners

    Ammon, Idaho 83406
    United States

    Site Not Available

  • Medical Research Partners

    Ammon 5583997, Idaho 5596512 83406
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Site Not Available

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

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Indiana University Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University Health University Hospital

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • UBMD Pediatrics

    Buffalo, New York 14203
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • UBMD Pediatrics

    Buffalo 5110629, New York 5128638 14203
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse 5140405, New York 5128638 13210
    United States

    Site Not Available

  • Frontier Clinical Research, LLC

    Smithfield 4561301, Pennsylvania 6254927 15478
    United States

    Site Not Available

  • Tribe Clinical Research, LLC- Greenville

    Greenville 4580543, South Carolina 4597040 29607
    United States

    Site Not Available

  • Driscoll Children's Hospital

    Corpus Christi, Texas 78411
    United States

    Site Not Available

  • Epic Medical Research - DeSoto

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Valley Institute of Research - Fort Worth

    Fort Worth, Texas 76164
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Texas Valley Clinical Research

    Weslaco, Texas 78596
    United States

    Site Not Available

  • JCCT - Juno Bellaire Site

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • Driscoll Children's Hospital

    Corpus Christi 4683416, Texas 4736286 78411
    United States

    Site Not Available

  • Epic Medical Research - DeSoto

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Valley Institute of Research - Fort Worth

    Fort Worth 4691930, Texas 4736286 76164
    United States

    Site Not Available

  • Biopharma Informatic, LLC

    Houston 4699066, Texas 4736286 77084
    United States

    Site Not Available

  • JCCT - Juno Bellaire Site

    Houston 4699066, Texas 4736286 77054
    United States

    Site Not Available

  • Texas Valley Clinical Research (TVCR) - Mission

    Mission 4711725, Texas 4736286 78572
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park 4728147, Texas 4736286 78231
    United States

    Site Not Available

  • Texas Valley Clinical Research

    Weslaco 4740629, Texas 4736286 78596
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Layton, Utah 84041
    United States

    Completed

  • Alliance for Multispecialty Research, LLC

    Layton 5777107, Utah 5549030 84041
    United States

    Site Not Available

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