RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT06439277

Registry updated: 2026-09-24

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Description

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.

Interventions

Tirzepatide (Drug)
Administered SC
Placebo (Drug)
Administered SC

Eligibility criteria

Inclusion Criteria: * 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). 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 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

Conditions

Obesity Weight Gain

Locations

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
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
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
Perth Children's Hospital — Perth, Australia
University of Sydney - Charles Perkins Centre — Sydney, Australia
Winterberry Research Inc. — Hamilton, Canada
Premier Clinical Trial Network — Hamilton, 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
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 Universitari i Politecnic La Fe — Valencia, Spain
China Medical University Hospital — Taichung, Taiwan
National Cheng Kung University Hospital — Tainan, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch — Taoyuan, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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