Actively Recruiting
Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind Trial
Led by Eli Lilly and Company · Updated on 2026-06-03
300
Participants Needed
73
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of tirzepatide in adolescents aged 12 to 17 years who have obesity with multiple weight-related health problems, such as hypertension, prediabetes, and high triglycerides. This Phase 3 randomized, double-blind study aims to understand how tirzepatide, combined with healthy eating and physical activity, affects body weight and cardiovascular risk factors in this population. Participants are those who have completed a prior 72-week study and may continue treatment for an additional 156 weeks. Participants will be randomly assigned to receive either tirzepatide or a placebo, both administered by weekly injections under the skin. The study lasts about 76 weeks with up to 23 visits, including lifestyle intervention support throughout. Those who finish the initial 72-week part and meet criteria can enroll in an extended treatment period lasting up to 156 weeks while continuing healthy nutrition and physical activity. During the study, participants will undergo various assessments including measurements of body mass index (BMI), body weight, blood pressure, blood sugar control (HbA1c), triglycerides, body fat by DXA scans, waist circumference, and sleep apnea index. These measures will be taken at the start and at week 72 to evaluate treatment impact. Safety and adherence will be closely monitored, and participants will have regular visits to support lifestyle changes and track health outcomes over the study duration.
CONDITIONS
Brief Title
A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a body mass index (BMI) at or above the 95th percentile for age and sex with at least 2 of these weight-related health problems: hypertension, prediabetes, or high triglycerides
- Have a history of at least 1 unsuccessful attempt to lose weight through diet
- Are able to give signed informed consent or assent as applicable
You will not qualify if you...
- Have had or plan to have weight loss surgery such as gastric bypass, sleeve gastrectomy, or gastric banding during the study
- Have lost more than 5 kg (11 lbs) in the 90 days before screening
- Have type 1 diabetes, history of ketoacidosis or hyperosmolar state
- Have type 2 diabetes or HbA1c greater than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 weeks
Participants receive tirzepatide or placebo once weekly by subcutaneous injection to evaluate the safety and efficacy for obesity and weight-related comorbidities.
Weekly visits for up to 72 weeks
Trial Site Locations
Total: 73 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Active, Not Recruiting
2
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, United States, 95821
Active, Not Recruiting
3
Nemours Children's Health - Delaware
Wilmington, Delaware, United States, 19803
Active, Not Recruiting
4
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
5
Medical Research Partners
Ammon, Idaho, United States, 83406
Active, Not Recruiting
6
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Active, Not Recruiting
7
Indiana University Health University Hospital
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
8
UBMD Pediatrics
Buffalo, New York, United States, 14203
Active, Not Recruiting
9
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Active, Not Recruiting
10
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78411
Active, Not Recruiting
11
Epic Medical Research - DeSoto
DeSoto, Texas, United States, 75115
Active, Not Recruiting
12
Valley Institute of Research - Fort Worth
Fort Worth, Texas, United States, 76164
Active, Not Recruiting
13
Consano Clinical Research, LLC
Shavano Park, Texas, United States, 78231
Active, Not Recruiting
14
Texas Valley Clinical Research
Weslaco, Texas, United States, 78596
Active, Not Recruiting
15
Alliance for Multispecialty Research, LLC
Layton, Utah, United States, 84041
Completed
16
Investigaciones Medicas Imoba Srl
Buenos Aires, Argentina, C1056ABH
Actively Recruiting
17
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina, C1056ABI
Actively Recruiting
18
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina, C1425AGC
Actively Recruiting
19
Fundación Respirar
Buenos Aires, Argentina, C1426ABP
Not Yet Recruiting
20
DIM Clínica Privada
Ramos Mejía, Argentina, B1704ETD
Actively Recruiting
21
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Argentina, T4000AXL
Actively Recruiting
22
Nightingale Research
Adelaide, Australia, 5000
Actively Recruiting
23
Cornerstone Dermatology
Coorparoo, Australia, 4151
Actively Recruiting
24
Hunter Medical Research Institute
Newcastle, Australia, 2305
Actively Recruiting
25
Perth Children's Hospital
Perth, Australia, 6009
Actively Recruiting
26
University of Sydney - Charles Perkins Centre
Sydney, Australia, 2006
Actively Recruiting
27
Alberta Children's Hospital
Calgary, Canada, T3B 6A8
Actively Recruiting
28
Winterberry Research Inc.
Hamilton, Canada, L8J 0B6
Actively Recruiting
29
Premier Clinical Trial Network
Hamilton, Canada, L8L5G4
Not Yet Recruiting
30
Bluewater Clinical Research Group Inc.
Sarnia, Canada, N7T 4X3
Completed
31
Centre Hospitalier Universitaire d'Angers
Angers, France, 49933
Active, Not Recruiting
32
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, France, 69677
Active, Not Recruiting
33
Hôpital Jeanne de Flandre
Lille, France, 59000
Active, Not Recruiting
34
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, France, 13385
Active, Not Recruiting
35
Hôpital Armand Trousseau
Paris, France, 75012
Active, Not Recruiting
36
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
Paris, France, 75019
Active, Not Recruiting
37
CHU de Toulouse - Hôpital des Enfants
Toulouse, France, 31059
Completed
38
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Active, Not Recruiting
39
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Active, Not Recruiting
40
Universitaetsklinikum Ulm
Ulm, Germany, 89075
Active, Not Recruiting
41
Emek Medical Center
Afula, Israel, 1834111
Active, Not Recruiting
42
Yitzhak Shamir Medical Center
Beer Yaacov, Israel, 70300
Completed
43
Soroka Medical Center
Beersheba, Israel, 8410101
Active, Not Recruiting
44
Rambam Health Care Campus
Haifa, Israel, 3109601
Active, Not Recruiting
45
Carmel Hospital
Haifa, Israel, 3436212
Active, Not Recruiting
46
Shaare Zedek Medical Center
Jerusalem, Israel, 9013102
Completed
47
Meir Medical Center
Kfar Saba, Israel, 4428164
Active, Not Recruiting
48
Schneider Children's Medical Center
Petah Tikva, Israel, 4920235
Active, Not Recruiting
49
Sheba Medical Center
Ramat Gan, Israel, 5262100
Active, Not Recruiting
50
Centro de Atención e Investigación Clínica
Aguascalientes, Mexico, 20129
Actively Recruiting
51
Centro de Investigacion Medica de Occidente, S.C.
Guadalajara, Mexico, 44260
Actively Recruiting
52
Christus - Latam Hub Center of Excellence and Innovation S.C.
Monterrey, Mexico, 64060
Actively Recruiting
53
Clínica García Flores SC
Monterrey, Mexico, 64610
Actively Recruiting
54
Consultorio Médico de Endocrinología y Pediatría
Puebla City, Mexico, 72190
Actively Recruiting
55
University Pediatric Hospital
San Juan, Puerto Rico, 00935
Completed
56
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Active, Not Recruiting
57
Hospital Universitario Reina Sofia
Córdoba, Spain, 14004
Active, Not Recruiting
58
Hospital Infantil Universitario Niño Jesús
Madrid, Spain, 28009
Active, Not Recruiting
59
H.R.U Málaga - Hospital General
Málaga, Spain, 29011
Active, Not Recruiting
60
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Active, Not Recruiting
61
China Medical University Hospital
Taichung, Taiwan, 404332
Active, Not Recruiting
62
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Active, Not Recruiting
63
National Taiwan University Hospital
Taipei, Taiwan, 10002
Completed
64
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Active, Not Recruiting
65
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0SL
Actively Recruiting
66
Royal Hospital for Children
Glagow, United Kingdom, G51 4TF
Actively Recruiting
67
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
68
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
69
Alder Hey Children's Hospital
Liverpool, United Kingdom, L14 5AB
Actively Recruiting
70
Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital
London, United Kingdom, WC1E 6DB
Actively Recruiting
71
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4PL
Actively Recruiting
72
Sheffield Children's Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
73
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here