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)
2 other identifiers
interventional
300
12 countries
75
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Jun 2024
Longer than P75 for phase_3 obesity
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 3, 2024
CompletedStudy Start
First participant enrolled
June 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
April 20, 2026
April 1, 2026
3.3 years
May 28, 2024
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (12)
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
- +7 more secondary outcomes
Study Arms (2)
Tirzepatide
EXPERIMENTALParticipants will receive tirzepatide subcutaneously (SC).
Placebo
PLACEBO COMPARATORParticipants will receive placebo SC.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, 95821, United States
Nemours Children's Health - Delaware
Wilmington, Delaware, 19803, United States
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
Medical Research Partners
Ammon, Idaho, 83406, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
UBMD Pediatrics
Buffalo, New York, 14203, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Epic Medical Research - DeSoto
DeSoto, Texas, 75115, United States
Valley Institute of Research - Fort Worth
Fort Worth, Texas, 76164, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041, United States
Investigaciones Medicas Imoba Srl
Buenos Aires, C1056ABH, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC, Argentina
Fundación Respirar
Buenos Aires, C1426ABP, Argentina
DIM Clínica Privada
Ramos Mejía, B1704ETD, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, T4000AXL, Argentina
Nightingale Research
Adelaide, 5000, Australia
Cornerstone Dermatology
Coorparoo, 4151, Australia
Hunter Medical Research Institute
Newcastle, 2305, Australia
Perth Children's Hospital
Perth, 6009, Australia
University of Sydney - Charles Perkins Centre
Sydney, 2006, Australia
The Children's Hospital at Westmead
Westmead, 2145, Australia
Alberta Children's Hospital
Calgary, T3B 6A8, Canada
Winterberry Research Inc.
Hamilton, L8J 0B6, Canada
Premier Clinical Trial Network
Hamilton, L8L5G4, Canada
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3, Canada
Centre Hospitalier Universitaire d'Angers
Angers, 49933, France
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69677, France
Hôpital Jeanne de Flandre
Lille, 59000, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, 13385, France
Hôpital Armand Trousseau
Paris, 75012, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
Paris, 75019, France
CHU de Toulouse - Hôpital des Enfants
Toulouse, 31059, France
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Universitaetsklinikum Ulm
Ulm, 89075, Germany
Emek Medical Center
Afula, 1834111, Israel
Yitzhak Shamir Medical Center
Beer Yaacov, 70300, Israel
Soroka Medical Center
Beersheba, 8410101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Carmel Hospital
Haifa, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, 9013102, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Schneider Children's Medical Center
Petah Tikva, 4920235, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Centro de Atención e Investigación Clínica
Aguascalientes, 20129, Mexico
Centro de Investigacion Medica de Occidente, S.C.
Guadalajara, 44260, Mexico
Christus - Latam Hub Center of Excellence and Innovation S.C.
Monterrey, 64060, Mexico
Clínica García Flores SC
Monterrey, 64610, Mexico
Consultorio Médico de Endocrinología y Pediatría
Puebla City, 72190, Mexico
University Pediatric Hospital
San Juan, 00935, Puerto Rico
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, 28009, Spain
H.R.U Málaga - Hospital General
Málaga, 29011, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
China Medical University Hospital
Taichung, 404332, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, 333, Taiwan
Addenbrooke's Hospital
Cambridge, CB2 0SL, United Kingdom
Royal Hospital for Children
Glagow, G51 4TF, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
Alder Hey Children's Hospital
Liverpool, L14 5AB, United Kingdom
Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital
London, WC1E 6DB, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4PL, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 3, 2024
Study Start
June 3, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
December 1, 2030
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.