Actively Recruiting

Phase 3
Age: 12Years - 17Years
All Genders
NCT06439277

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Led by Eli Lilly and Company · Updated on 2026-05-12

300

Participants Needed

73

Research Sites

338 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have body mass index (BMI) equal to or above the 95th percentile for age and sex with at least 2 of the following weight-related comorbidities: hypertension, prediabetes, and hypertriglyceridemia
  • Have a 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 the participant (when applicable)
Not Eligible

You will not qualify if you...

  • Have undergone or plan to undergo weight reduction surgery during the study, such as gastric bypass, sleeve gastrectomy, or restrictive bariatric surgery like Lap-Band
  • Have lost more than 5 kg (11 lbs) in the 90 days before screening
  • Have type 1 diabetes or 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

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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

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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