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NCT06439277RecruitingPhase 3

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)

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
300 (estimated)
First submitted
28 May 2024
Start date
3 Jun 2024
Primary completion date
Oct 2027
Lead sponsor
Eli Lilly and Company
Diseases
Obesity
NCT number
NCT06439277

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 300
  • From 3 Jun 2024 to the primary completion date, Oct 2027
  • 69 sites in 12 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
  • 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

Lab values

  • Have type 2 diabetes or have a HbA1c \> 6.4% at screening

Who the study is looking for

  • 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).

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (69)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Investigaciones Medicas Imoba Srl
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Buenos AiresArgentinaActive, not recruiting
Centro de Investigaciones Metabólicas (CINME)
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Buenos AiresArgentinaActive, not recruiting
Fundacion Respirar
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Buenos AiresArgentinaCompleted
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Buenos AiresArgentinaActive, not recruiting
DIM Clínica Privada
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Ramos MejíaArgentinaActive, not recruiting
Centro de Investigaciones Médicas Tucuman
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SAN M. de TucumanArgentinaActive, not recruiting
Nightingale Research
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AdelaideAustraliaCompleted
Cornerstone Dermatology
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CoorparooAustraliaActive, not recruiting
Perth Children's Hospital
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PerthAustraliaCompleted
University of Sydney - Charles Perkins Centre
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SydneyAustraliaActive, not recruiting
Premier Clinical Trial Network
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HamiltonCanadaNot yet recruiting
Winterberry Research Inc.
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HamiltonCanadaRecruiting
Bluewater Clinical Research Group Inc.
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SarniaCanadaCompleted
Universitaetsklinikum Koeln
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CologneGermanyActive, not recruiting
Universitatsklinikum Leipzig
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LeipzigGermanyActive, not recruiting
Universitaetsklinikum Ulm
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UlmGermanyActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Hospital Infantil Universitario Nino Jesus
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MadridSpainActive, not recruiting
H.R.U Málaga - Hospital General
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MálagaSpainActive, not recruiting
Hospital Universitari i Politécnic La Fe
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ValenciaSpainActive, not recruiting
Centre Hospitalier Universitaire D'Angers
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AngersFranceActive, not recruiting
Hospices Civils de Lyon - Hopital Louis Pradel
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BronFranceActive, not recruiting
Hôpital Jeanne de Flandre
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LilleFranceActive, not recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
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MarseilleFranceActive, not recruiting
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
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ParisFranceActive, not recruiting
Hôpital Armand-Trousseau
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ParisFranceActive, not recruiting
CHU de Toulouse - Hôpital des Enfants
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ToulouseFranceCompleted
Addenbrooke's Hospital
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CambridgeUnited KingdomActive, not recruiting
Royal Hospital for Children
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GlagowUnited KingdomActive, not recruiting
Leeds General Infirmary
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LeedsUnited KingdomActive, not recruiting
Leicester Royal Infirmary
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LeicesterUnited KingdomCompleted
Alder Hey Children's Hospital
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LiverpoolUnited KingdomCompleted
Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital
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LondonUnited KingdomCompleted
Royal Victoria Infirmary
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Newcastle upon TyneUnited KingdomActive, not recruiting
Sheffield Children's Hospital
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SheffieldUnited KingdomActive, not recruiting
Southampton General Hospital
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SouthamptonUnited KingdomCompleted
Emek Medical Center
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AfulaIsraelCompleted
Soroka Medical Center
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BeershebaIsraelActive, not recruiting
Rambam Health Care Campus
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HaifaIsraelActive, not recruiting
Carmel Hospital
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HaifaIsraelActive, not recruiting
Shaare Zedek Medical Center
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JerusalemIsraelCompleted
Meir Medical Center
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Kfar SabaIsraelActive, not recruiting
Schneider Children's Medical Center
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Petah TikvaIsraelActive, not recruiting
Sheba medical center
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Ramat GanIsraelActive, not recruiting
Centro de Atención e Investigación Clínica
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AguascalientesMexicoActive, not recruiting
Centro de Investigacion Medica de Occidente, S.C.
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GuadalajaraMexicoActive, not recruiting
Clínica García Flores SC
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MonterreyMexicoActive, not recruiting
Christus - Latam Hub Center of Excellence and Innovation S.C.
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MonterreyMexicoActive, not recruiting
Consultorio Médico de Endocrinología y Pediatría
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Puebla CityMexicoActive, not recruiting
University Pediatric Hospital
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San JuanPuerto RicoCompleted
China Medical University Hospital
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TaichungTaiwanActive, not recruiting
National Cheng Kung University Hospital
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TainanTaiwanActive, not recruiting
National Taiwan University Hospital
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TaipeiTaiwanCompleted
Chang Gung Medical Foundation-Linkou Branch
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TaoyuanTaiwanActive, not recruiting
Medical Research Partners
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AmmonUnited StatesActive, not recruiting
UBMD Pediatrics
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BuffaloUnited StatesActive, not recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
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ChicagoUnited StatesActive, not recruiting
Driscoll Children's Hospital
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Corpus ChristiUnited StatesActive, not recruiting
Epic Medical Research - DeSoto
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DeSotoUnited StatesActive, not recruiting
Valley Institute of Research - Fort Worth
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Fort WorthUnited StatesActive, not recruiting
Indiana University Health University Hospital
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IndianapolisUnited StatesActive, not recruiting
Alliance for Multispecialty Research, LLC
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LaytonUnited StatesCompleted
Children's Hospital Los Angeles
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Los AngelesUnited StatesActive, not recruiting
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
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SacramentoUnited StatesActive, not recruiting
Consano Clinical Research, LLC
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Shavano ParkUnited StatesActive, not recruiting
SUNY Upstate Medical University
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SyracuseUnited StatesActive, not recruiting
Texas Valley Clinical Research
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WeslacoUnited StatesActive, not recruiting
Nemours Children's Health, Delaware
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WilmingtonUnited StatesActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.