A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Recruiting · NCT06439277 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboTirzepatide
What this trial is about
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.
Who can take part
Age range
12 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 8 US states.
- 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
- Nightingale Research - Adelaide, Australia
- Emek Medical Center - Afula, Israel
- Centro de Atención e Investigación Clínica - Aguascalientes, Mexico
- Centre Hospitalier Universitaire d'Angers - Angers, France
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Soroka Medical Center - Beersheba, Israel
- Hospices Civils de Lyon - Hopital Louis Pradel - Bron, France
- 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
- Addenbrooke's Hospital - Cambridge, United Kingdom
- Universitaetsklinikum Koeln - Cologne, Germany
- Cornerstone Dermatology - Coorparoo, Australia
- Hospital Universitario Reina Sofia - Córdoba, Spain
- Royal Hospital for Children - Glagow, United Kingdom
- Centro de Investigacion Medica de Occidente, S.C. - Guadalajara, Mexico
- Rambam Health Care Campus - Haifa, Israel
- Carmel Hospital - Haifa, Israel
- Winterberry Research Inc. - Hamilton, Canada
- Premier Clinical Trial Network - Hamilton, Canada
- Shaare Zedek Medical Center - Jerusalem, Israel
- Meir Medical Center - Kfar Saba, Israel
- Leeds General Infirmary - Leeds, United Kingdom
- Leicester Royal Infirmary - Leicester, United Kingdom
- Universitätsklinikum Leipzig - Leipzig, Germany
- Hôpital Jeanne de Flandre - Lille, France
- Alder Hey Children's Hospital - Liverpool, United Kingdom
- Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital - London, United Kingdom
- Hospital Infantil Universitario Niño Jesús - Madrid, Spain
- Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone - Marseille, France
- Christus - Latam Hub Center of Excellence and Innovation S.C. - Monterrey, Mexico
- Clínica García Flores SC - Monterrey, Mexico
- H.R.U Málaga - Hospital General - Málaga, Spain
- Royal Victoria Infirmary - Newcastle upon Tyne, United Kingdom
- Hôpital Armand Trousseau - Paris, France
- Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T - Paris, France
- Perth Children's Hospital - Perth, Australia
- Schneider Children's Medical Center - Petah Tikva, Israel
- Consultorio Médico de Endocrinología y Pediatría - Puebla City, Mexico
- Sheba Medical Center - Ramat Gan, Israel
- DIM Clínica Privada - Ramos Mejía, Argentina
- Centro de Investigaciones Médicas Tucuman - SAN M. de Tucuman, Argentina
- University Pediatric Hospital - San Juan, Puerto Rico
- Bluewater Clinical Research Group Inc. - Sarnia, Canada
- Sheffield Children's Hospital - Sheffield, United Kingdom
Showing 60 of 69 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →