NCT06439277RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 28 May 2024
- Start date
- 3 Jun 2024
- Primary completion date
- Oct 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT06439277
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 300
- From 3 Jun 2024 to the primary completion date, Oct 2027
- 69 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
- 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
Lab values
- Have type 2 diabetes or have a HbA1c \> 6.4% at screening
Who the study is looking for
- 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).
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (69)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Investigaciones Medicas Imoba Srl Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Active, not recruiting |
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Active, not recruiting |
| Fundacion Respirar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Completed |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Active, not recruiting |
| DIM Clínica Privada Coordinator of this site? Confirm its status | Ramos Mejía | Argentina | Active, not recruiting |
| Centro de Investigaciones Médicas Tucuman Coordinator of this site? Confirm its status | SAN M. de Tucuman | Argentina | Active, not recruiting |
| Nightingale Research Coordinator of this site? Confirm its status | Adelaide | Australia | Completed |
| Cornerstone Dermatology Coordinator of this site? Confirm its status | Coorparoo | Australia | Active, not recruiting |
| Perth Children's Hospital Coordinator of this site? Confirm its status | Perth | Australia | Completed |
| University of Sydney - Charles Perkins Centre Coordinator of this site? Confirm its status | Sydney | Australia | Active, not recruiting |
| Premier Clinical Trial Network Coordinator of this site? Confirm its status | Hamilton | Canada | Not yet recruiting |
| Winterberry Research Inc. Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Bluewater Clinical Research Group Inc. Coordinator of this site? Confirm its status | Sarnia | Canada | Completed |
| Universitaetsklinikum Koeln Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Universitatsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| H.R.U Málaga - Hospital General Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire D'Angers Coordinator of this site? Confirm its status | Angers | France | Active, not recruiting |
| Hospices Civils de Lyon - Hopital Louis Pradel Coordinator of this site? Confirm its status | Bron | France | Active, not recruiting |
| Hôpital Jeanne de Flandre Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hôpital Armand-Trousseau Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| CHU de Toulouse - Hôpital des Enfants Coordinator of this site? Confirm its status | Toulouse | France | Completed |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Active, not recruiting |
| Royal Hospital for Children Coordinator of this site? Confirm its status | Glagow | United Kingdom | Active, not recruiting |
| Leeds General Infirmary Coordinator of this site? Confirm its status | Leeds | United Kingdom | Active, not recruiting |
| Leicester Royal Infirmary Coordinator of this site? Confirm its status | Leicester | United Kingdom | Completed |
| Alder Hey Children's Hospital Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Completed |
| Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Completed |
| Royal Victoria Infirmary Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Active, not recruiting |
| Sheffield Children's Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Active, not recruiting |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Completed |
| Emek Medical Center Coordinator of this site? Confirm its status | Afula | Israel | Completed |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Active, not recruiting |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Active, not recruiting |
| Carmel Hospital Coordinator of this site? Confirm its status | Haifa | Israel | Active, not recruiting |
| Shaare Zedek Medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Completed |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Active, not recruiting |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petah Tikva | Israel | Active, not recruiting |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Active, not recruiting |
| Centro de Atención e Investigación Clínica Coordinator of this site? Confirm its status | Aguascalientes | Mexico | Active, not recruiting |
| Centro de Investigacion Medica de Occidente, S.C. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Active, not recruiting |
| Clínica García Flores SC Coordinator of this site? Confirm its status | Monterrey | Mexico | Active, not recruiting |
| Christus - Latam Hub Center of Excellence and Innovation S.C. Coordinator of this site? Confirm its status | Monterrey | Mexico | Active, not recruiting |
| Consultorio Médico de Endocrinología y Pediatría Coordinator of this site? Confirm its status | Puebla City | Mexico | Active, not recruiting |
| University Pediatric Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Completed |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Active, not recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Active, not recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Completed |
| Chang Gung Medical Foundation-Linkou Branch Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Active, not recruiting |
| Medical Research Partners Coordinator of this site? Confirm its status | Ammon | United States | Active, not recruiting |
| UBMD Pediatrics Coordinator of this site? Confirm its status | Buffalo | United States | Active, not recruiting |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Active, not recruiting |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | United States | Active, not recruiting |
| Epic Medical Research - DeSoto Coordinator of this site? Confirm its status | DeSoto | United States | Active, not recruiting |
| Valley Institute of Research - Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Active, not recruiting |
| Indiana University Health University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Active, not recruiting |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Layton | United States | Completed |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Active, not recruiting |
| Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology Coordinator of this site? Confirm its status | Sacramento | United States | Active, not recruiting |
| Consano Clinical Research, LLC Coordinator of this site? Confirm its status | Shavano Park | United States | Active, not recruiting |
| SUNY Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Active, not recruiting |
| Texas Valley Clinical Research Coordinator of this site? Confirm its status | Weslaco | United States | Active, not recruiting |
| Nemours Children's Health, Delaware Coordinator of this site? Confirm its status | Wilmington | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.