A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
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)
- Obesity
- Weight Gain
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Eli Lilly and Company
- Enrolment target
- 300
- Started
- 3 June 2024
- Main results due
- October 2027
- Study sites
- 69
- Registry updated
- 24 September 2026
Can you take part?
- Ages 12 years to 17 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(69)
Children's Hospital Los Angeles
Los Angeles, California, United States
Active, not recruiting
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, United States
Active, not recruiting
Nemours Children's Health - Delaware
Wilmington, Delaware, United States
Active, not recruiting
Medical Research Partners
Ammon, Idaho, United States
Active, not recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Active, not recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Active, not recruiting
UBMD Pediatrics
Buffalo, New York, United States
Active, not recruiting
SUNY Upstate Medical University
Syracuse, New York, United States
Active, not recruiting
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Active, not recruiting
Epic Medical Research - DeSoto
DeSoto, Texas, United States
Active, not recruiting
Valley Institute of Research - Fort Worth
Fort Worth, Texas, United States
Active, not recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Active, not recruiting
Texas Valley Clinical Research
Weslaco, Texas, United States
Active, not recruiting
Alliance for Multispecialty Research, LLC
Layton, Utah, United States
Completed
Investigaciones Medicas Imoba Srl
Buenos Aires, Argentina
Active, not recruiting
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina
Active, not recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina
Active, not recruiting
Fundación Respirar
Buenos Aires, Argentina
Completed
DIM Clínica Privada
Ramos Mejía, Argentina
Active, not recruiting
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Argentina
Active, not recruiting
Nightingale Research
Adelaide, Australia
Completed
Cornerstone Dermatology
Coorparoo, Australia
Active, not recruiting
Perth Children's Hospital
Perth, Australia
Completed
University of Sydney - Charles Perkins Centre
Sydney, Australia
Active, not recruiting
Winterberry Research Inc.
Hamilton, Canada
Recruiting
Premier Clinical Trial Network
Hamilton, Canada
Not yet recruiting
Bluewater Clinical Research Group Inc.
Sarnia, Canada
Completed
Centre Hospitalier Universitaire d'Angers
Angers, France
Active, not recruiting
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, France
Active, not recruiting
Hôpital Jeanne de Flandre
Lille, France
Active, not recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, France
Active, not recruiting
Hôpital Armand Trousseau
Paris, France
Active, not recruiting
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
Paris, France
Active, not recruiting
CHU de Toulouse - Hôpital des Enfants
Toulouse, France
Completed
Universitaetsklinikum Koeln
Cologne, Germany
Active, not recruiting
Universitätsklinikum Leipzig
Leipzig, Germany
Active, not recruiting
Universitaetsklinikum Ulm
Ulm, Germany
Active, not recruiting
Emek Medical Center
Afula, Israel
Completed
Soroka Medical Center
Beersheba, Israel
Active, not recruiting
Rambam Health Care Campus
Haifa, Israel
Active, not recruiting
Carmel Hospital
Haifa, Israel
Active, not recruiting
Shaare Zedek Medical Center
Jerusalem, Israel
Completed
Meir Medical Center
Kfar Saba, Israel
Active, not recruiting
Schneider Children's Medical Center
Petah Tikva, Israel
Active, not recruiting
Sheba Medical Center
Ramat Gan, Israel
Active, not recruiting
Centro de Atención e Investigación Clínica
Aguascalientes, Mexico
Active, not recruiting
Centro de Investigacion Medica de Occidente, S.C.
Guadalajara, Mexico
Active, not recruiting
Christus - Latam Hub Center of Excellence and Innovation S.C.
Monterrey, Mexico
Active, not recruiting
Clínica García Flores SC
Monterrey, Mexico
Active, not recruiting
Consultorio Médico de Endocrinología y Pediatría
Puebla City, Mexico
Active, not recruiting
University Pediatric Hospital
San Juan, Puerto Rico
Completed
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Active, not recruiting
Hospital Universitario Reina Sofia
Córdoba, Spain
Active, not recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Active, not recruiting
H.R.U Málaga - Hospital General
Málaga, Spain
Active, not recruiting
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Active, not recruiting
China Medical University Hospital
Taichung, Taiwan
Active, not recruiting
National Cheng Kung University Hospital
Tainan, Taiwan
Active, not recruiting
National Taiwan University Hospital
Taipei, Taiwan
Completed
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan
Active, not recruiting
Showing 60 of 69 sites — filter to narrow it down. 1 of the 69 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06439277. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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