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

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Obesity

Treatment

Tirzepatide

Placebo

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.

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: Tirzepatide
Phase: 3
Study Start date:
June 03, 2024
Estimated Completion Date:
June 30, 2027

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

  • DIM Clínica Privada

    Ramos Mejía, Buenos Aires B1704ETD
    Argentina

    Active - Recruiting

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1056ABH
    Argentina

    Active - Recruiting

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

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

    Active - Recruiting

  • 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

  • Fundación Respirar

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

    Active - Recruiting

  • Hunter Medical Research Institute

    Newcastle, New South Wales 2305
    Australia

    Active - Recruiting

  • University of Sydney - Charles Perkins Centre

    Sydney, New South Wales 2006
    Australia

    Active - Recruiting

  • The Children's Hospital at Westmead

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Cornerstone Dermatology

    Coorparoo, Queensland 4151
    Australia

    Active - Recruiting

  • Nightingale Research

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Perth Children's Hospital

    Perth, Western Australia 6009
    Australia

    Active - Recruiting

  • Alberta Children's Hospital

    Calgary, Alberta T3B 6A8
    Canada

    Active - Recruiting

  • Alberta Children's Hospital Loc. 1

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • Kids Clinic

    Ajax, Ontario L1Z 0M1
    Canada

    Active - Recruiting

  • 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

  • Premier Clinical Trial Network

    Hamilton, Ontario L8L5G4
    Canada

    Active - Recruiting

  • Winterberry Research Inc.

    Hamilton, Ontario L8J 0B6
    Canada

    Active - Recruiting

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario N7T 4X3
    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

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, Bouches-du-Rhône 13385
    France

    Active - Recruiting

  • CHU de Toulouse - Hôpital des Enfants

    Toulouse, Haute-Garonne 31059
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire d'Angers

    Angers, Maine-et-Loire 49933
    France

    Active - Recruiting

  • Hôpital Jeanne de Flandre

    Lille, Nord-Pas-de-Calais 59000
    France

    Active - Recruiting

  • Hospices Civils de Lyon - Hopital Louis Pradel

    Bron, Rhône 69677
    France

    Active - Recruiting

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

    Paris, 75019
    France

    Active - Recruiting

  • Hôpital Armand Trousseau

    Paris, 75012
    France

    Active - Recruiting

  • Universitaetsklinikum Ulm

    Ulm, Baden-Württemberg 89075
    Germany

    Active - Recruiting

  • 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

    Active - Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, Sachsen 04103
    Germany

    Active - Recruiting

  • Soroka Medical Center

    Be'er Sheva, HaDarom 8410101
    Israel

    Active - Recruiting

  • Yitzhak Shamir Medical Center

    Beer Yaacov, HaMerkaz 70300
    Israel

    Active - Recruiting

  • Meir Medical Center

    Kfar Saba, HaMerkaz 4428164
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah-Tikva, HaMerkaz 4920235
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Active - Recruiting

  • Emek Medical Center

    Afula, HaTsafon 1834111
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, HaTsafon 3109601
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9013102
    Israel

    Active - Recruiting

  • Carmel Hospital

    Haifa, Ḥeifā 3436212
    Israel

    Active - Recruiting

  • Pediatrics Endocrinology

    Haifa, Ḥeifā 3436212
    Israel

    Site Not Available

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

    Guadalajara, Jalisco 44260
    Mexico

    Active - Recruiting

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

    Zapopan, Jalisco 45116
    Mexico

    Site Not Available

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

    Monterrey, Nuevo León 64060
    Mexico

    Active - Recruiting

  • Clínica García Flores SC

    Monterrey, Nuevo León 64610
    Mexico

    Active - Recruiting

  • Centro de Atención e Investigación Clínica

    Aguascalientes, 20129
    Mexico

    Active - Recruiting

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla, 72190
    Mexico

    Active - Recruiting

  • University Pediatric Hospital

    San Juan, 00935
    Puerto Rico

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Cordoba, Andalucía 14004
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona] 08035
    Spain

    Active - Recruiting

  • Hospital Infantil Universitario Niño Jesús

    Madrid, Madrid, Comunidad De 28009
    Spain

    Active - Recruiting

  • H.R.U Málaga - Hospital General

    Málaga, 29011
    Spain

    Active - Recruiting

  • Hospital Regional Universitario

    Málaga, 29011
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Active - Recruiting

  • China Medical University Hospital

    Taichung, 404332
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Cheng-Kung Uni. Hosp.

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • 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

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire CB2 0SL
    United Kingdom

    Active - Recruiting

  • Leicester Royal Infirmary

    Leicester, England LE1 5WW
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Active - Recruiting

  • University Hospital Southampton

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital

    London, London, City Of WC1E 6DB
    United Kingdom

    Active - Recruiting

  • Royal Hospital for Children

    Glagow, Scotland G51 4TF
    United Kingdom

    Site Not Available

  • Leeds General Infirmary

    Leeds, LS1 3EX
    United Kingdom

    Active - Recruiting

  • Alder Hey Children's Hospital

    Liverpool, L14 5AB
    United Kingdom

    Active - Recruiting

  • Sheffield Children's Hospital

    Sheffield, S10 2TH
    United Kingdom

    Active - Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Nemours Children's Health - Delaware

    Wilmington, Delaware 19803
    United States

    Active - Recruiting

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

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

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Indiana University Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • UBMD Pediatrics

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Driscoll Children's Hospital

    Corpus Christi, Texas 78411
    United States

    Active - Recruiting

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Active - Recruiting

  • Texas Valley Clinical Research

    Weslaco, Texas 78596
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Layton, Utah 84041
    United States

    Active - Recruiting

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