ObesityPhase 3NCT06439277
A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
A Phase 3 study testing Tirzepatide in people with Obesity and Weight Gain, run by Eli Lilly and Company at 69 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity, Weight Gain
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 69 sitesin 12 countries
- Study dates
- 3 Jun 2024to Dec 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
69 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
69 sites in 12 countries
United States14 sites
- Active, not recruiting
Medical Research Partners
Ammon, Idaho, 83406
- Active, not recruiting
UBMD Pediatrics
Buffalo, New York, 14203
- Active, not recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Active, not recruiting
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
- Active, not recruiting
Epic Medical Research - DeSoto
DeSoto, Texas, 75115
- Active, not recruiting
Valley Institute of Research - Fort Worth
Fort Worth, Texas, 76164
- Active, not recruiting
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
- Completed
Alliance for Multispecialty Research, LLC
Layton, Utah, 84041
- Active, not recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
- Active, not recruiting
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, 95821
- Active, not recruiting
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
- Active, not recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
- Active, not recruiting
Texas Valley Clinical Research
Weslaco, Texas, 78596
- Active, not recruiting
Nemours Children's Health - Delaware
Wilmington, Delaware, 19803
United Kingdom9 sites
- Active, not recruiting
Addenbrooke's Hospital
Cambridge, CB2 0SL
- Active, not recruiting
Royal Hospital for Children
Glagow, G51 4TF
- Active, not recruiting
Leeds General Infirmary
Leeds, LS1 3EX
- Completed
Leicester Royal Infirmary
Leicester, LE1 5WW
- Completed
Alder Hey Children's Hospital
Liverpool, L14 5AB
- Completed
Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital
London, WC1E 6DB
- Active, not recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4PL
- Active, not recruiting
Sheffield Children's Hospital
Sheffield, S10 2TH
- Completed
Southampton General Hospital
Southampton, SO16 6YD
Israel8 sites
- Completed
Emek Medical Center
Afula, 1834111
- Active, not recruiting
Soroka Medical Center
Beersheba, 8410101
- Active, not recruiting
Rambam Health Care Campus
Haifa, 3109601
- Active, not recruiting
Carmel Hospital
Haifa, 3436212
- Completed
Shaare Zedek Medical Center
Jerusalem, 9013102
- Active, not recruiting
Meir Medical Center
Kfar Saba, 4428164
- Active, not recruiting
Schneider Children's Medical Center
Petah Tikva, 4920235
- Active, not recruiting
Sheba Medical Center
Ramat Gan, 5262100
France7 sites
- Active, not recruiting
Centre Hospitalier Universitaire d'Angers
Angers, 49933
- Active, not recruiting
Hospices Civils de Lyon - Hopital Louis Pradel
Bron, 69677
- Active, not recruiting
Hôpital Jeanne de Flandre
Lille, 59000
- Active, not recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, 13385
- Active, not recruiting
Hôpital Armand Trousseau
Paris, 75012
- Active, not recruiting
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
Paris, 75019
- Completed
CHU de Toulouse - Hôpital des Enfants
Toulouse, 31059
Argentina6 sites
- Active, not recruiting
Investigaciones Medicas Imoba Srl
Buenos Aires, C1056ABH
- Active, not recruiting
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI
- Active, not recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC
- Completed
Fundación Respirar
Buenos Aires, C1426ABP
- Active, not recruiting
DIM Clínica Privada
Ramos Mejía, B1704ETD
- Active, not recruiting
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, T4000AXL
Mexico5 sites
- Active, not recruiting
Centro de Atención e Investigación Clínica
Aguascalientes, 20129
- Active, not recruiting
Centro de Investigacion Medica de Occidente, S.C.
Guadalajara, 44260
- Active, not recruiting
Christus - Latam Hub Center of Excellence and Innovation S.C.
Monterrey, 64060
- Active, not recruiting
Clínica García Flores SC
Monterrey, 64610
- Active, not recruiting
Consultorio Médico de Endocrinología y Pediatría
Puebla City, 72190
Spain5 sites
- Active, not recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
- Active, not recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Active, not recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, 28009
- Active, not recruiting
H.R.U Málaga - Hospital General
Málaga, 29011
- Active, not recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Australia4 sites
- Completed
Nightingale Research
Adelaide, 5000
- Active, not recruiting
Cornerstone Dermatology
Coorparoo, 4151
- Completed
Perth Children's Hospital
Perth, 6009
- Active, not recruiting
University of Sydney - Charles Perkins Centre
Sydney, 2006
Taiwan4 sites
- Active, not recruiting
China Medical University Hospital
Taichung, 404332
- Active, not recruiting
National Cheng Kung University Hospital
Tainan, 704
- Completed
National Taiwan University Hospital
Taipei, 10002
- Active, not recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Canada3 sites, 2 recruiting
- Recruiting
Winterberry Research Inc.
Hamilton, L8J 0B6
365-366-6267
Steven Zizzo
- Not yet recruiting
Premier Clinical Trial Network
Hamilton, L8L5G4
905 407 8945
Richard Tytus
- Completed
Bluewater Clinical Research Group Inc.
Sarnia, N7T 4X3
Germany3 sites
- Active, not recruiting
Universitaetsklinikum Koeln
Cologne, 50937
- Active, not recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
- Active, not recruiting
Universitaetsklinikum Ulm
Ulm, 89075
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Obesity, Weight Gain
- Being tested
- Tirzepatide, Placebo
- Medical subject headings
- Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide subcutaneously (SC). Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Participants will receive placebo SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change from Baseline in Body Mass Index (BMI)
Measured: 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
Measured: Baseline, Week 72
Secondary outcomes (12)
Percentage of Participants Who Achieve BMI Reduction of ≥ 5%
Measured: Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 10%
Measured: Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 15%
Measured: Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 20%
Measured: Week 72
Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Baseline, Week 72
Percent Change from Baseline in Triglycerides
Measured: Baseline, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)
Measured: Baseline, Week 72
Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)
Measured: Baseline, Week 72
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)
Measured: Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline, Week 72
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 72
Change from Baseline in Waist Circumference
Measured: Baseline, Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start3 Jun 2024
- Primary completionOct 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439277
- Sponsor's protocol ID
- 18832
- Other IDs
- I8F-MC-GPIX
- Status last verified
- Sep 2026
- First submitted
- 28 May 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.