A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
- Registration Number
- NCT06439277
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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).
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo SC. Tirzepatide Tirzepatide Participants will receive tirzepatide subcutaneously (SC).
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Mass Index (BMI) Baseline, Week 72 A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity Baseline, Week 72
- Secondary Outcome Measures
Name Time Method Change from Baseline in Waist Circumference Baseline, Week 72 Percent Change from Baseline in Body Weight Baseline, Week 72 Percentage of Participants Who Achieve BMI Reduction of ≥ 5% Week 72 Percentage of Participants Who Achieve BMI Reduction of ≥ 10% Week 72 Percentage of Participants Who Achieve BMI Reduction of ≥ 15% Week 72 Percentage of Participants Who Achieve BMI Reduction of ≥ 20% Week 72 Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 72 Percent Change from Baseline in Triglycerides Baseline, Week 72 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 72 Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI) Baseline, Week 72 Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA) Baseline, Week 72 Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 72
Trial Locations
- Locations (72)
Fundación Respirar
🇦🇷Buenos Aires, Argentina
Consultorio Médico de Endocrinología y Pediatría
🇲🇽Puebla, Mexico
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
CenExel iResearch, LLC
🇺🇸Decatur, Georgia, 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
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
DIM Clínica Privada
🇦🇷Ramos Mejía, Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Investigaciones Médicas Tucuman
🇦🇷SAN M. DE Tucuman, Tucumán, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Hunter Medical Research Institute
🇦🇺Newcastle, New South Wales, Australia
University of Sydney - Charles Perkins Centre
🇦🇺Sydney, New South Wales, Australia
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Cornerstone Dermatology
🇦🇺Coorparoo, Queensland, Australia
Nightingale Research
🇦🇺Adelaide, South Australia, Australia
Perth Children's Hospital
🇦🇺Perth, Western Australia, Australia
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
Kids Clinic
🇨🇦Ajax, Ontario, Canada
Winterberry Research Inc.
🇨🇦Hamilton, Ontario, Canada
Premier Clinical Trial Network
🇨🇦Hamilton, Ontario, Canada
Bluewater Clinical Research Group Inc.
🇨🇦Sarnia, Ontario, Canada
Maison de Santé Prévention
🇨🇦Montreal, Quebec, Canada
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
🇫🇷Marseille, Bouches-du-Rhône, France
CHU de Toulouse - Hôpital des Enfants
🇫🇷Toulouse, Haute-Garonne, France
Centre Hospitalier Universitaire d'Angers
🇫🇷Angers, Maine-et-Loire, France
Hôpital Jeanne de Flandre
🇫🇷Lille, Nord-Pas-de-Calais, France
Hospices Civils de Lyon - Hopital Louis Pradel
🇫🇷Bron, Rhône, France
Hôpital Armand Trousseau
🇫🇷Paris, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
🇫🇷Paris, France
Universitaetsklinikum Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
Universitaetsklinikum Koeln
🇩🇪Köln, Nordrhein-Westfalen, Germany
Universitätsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Soroka Medical Center
🇮🇱Be'er Sheva, HaDarom, Israel
Yitzhak Shamir Medical Center
🇮🇱Beer Yaacov, HaMerkaz, Israel
Meir Medical Center
🇮🇱Kfar Saba, HaMerkaz, Israel
Schneider Children's Medical Center
🇮🇱Petah-Tikva, HaMerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Emek Medical Center
🇮🇱Afula, HaTsafon, Israel
Rambam Health Care Campus
🇮🇱Haifa, HaTsafon, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Carmel Hospital
🇮🇱Haifa, Ḥeifā, Israel
Centro de Investigacion Medica de Occidente, S.C.
🇲🇽Guadalajara, Jalisco, Mexico
Christus - Latam Hub Center of Excellence and Innovation S.C.
🇲🇽Monterrey, Nuevo León, Mexico
Clínica García Flores SC
🇲🇽Monterrey, Nuevo León, Mexico
Centro de Atención e Investigación Clínica
🇲🇽Aguascalientes, Mexico
University Pediatric Hospital
🇵🇷San Juan, Puerto Rico
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Andalucía, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Hospital Infantil Universitario Niño Jesús
🇪🇸Madrid, Madrid, Comunidad De, Spain
H.R.U Málaga - Hospital General
🇪🇸Málaga, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸València, 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, Cambridgeshire, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, Hampshire, United Kingdom
Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital
🇬🇧London, London, City Of, United Kingdom
Royal Hospital for Children
🇬🇧Glagow, Scotland, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Alder Hey Children's Hospital
🇬🇧Liverpool, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom