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

August 6, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1056ABI
        • Active, not recruiting
        • Centro de Investigaciones Metabólicas (CINME)
      • Buenos Aires, Argentina, C1425AGC
        • Active, not recruiting
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Buenos Aires, Argentina, C1056ABH
        • Active, not recruiting
        • Investigaciones Medicas Imoba Srl
      • Buenos Aires, Argentina, C1426ABP
        • Completed
        • Fundación Respirar
      • Ramos Mejía, Argentina, B1704ETD
        • Active, not recruiting
        • DIM Clinica Privada
      • SAN M. de Tucuman, Argentina, T4000AXL
        • Active, not recruiting
        • Centro de Investigaciones Medicas Tucuman
  • Australia
      • Adelaide, Australia, 5000
        • Completed
        • Nightingale Research
      • Coorparoo, Australia, 4151
        • Active, not recruiting
        • Cornerstone Dermatology
      • Newcastle, Australia, 2305
        • Recruiting
        • Hunter Medical Research Institute
        • Principal Investigator:
          • Shamasunder Acharya
        • Contact:
          • Phone Number: 61466575934
      • Perth, Australia, 6009
        • Completed
        • Perth Children's Hospital
      • Sydney, Australia, 2006
        • Active, not recruiting
        • University of Sydney - Charles Perkins Centre
  • Canada
      • Hamilton, Canada, L8J 0B6
        • Recruiting
        • Winterberry Research Inc.
        • Principal Investigator:
          • Steven Zizzo
        • Contact:
          • Phone Number: 365-366-6267
      • Hamilton, Canada, L8L5G4
        • Not yet recruiting
        • Premier Clinical Trial Network
        • Principal Investigator:
          • Richard Tytus
        • Contact:
          • Phone Number: 905 407 8945
      • Sarnia, Canada, N7T 4X3
        • Completed
        • Bluewater Clinical Research Group Inc.
  • France
      • Angers, France, 49933
        • Active, not recruiting
        • Centre Hospitalier Universitaire d'Angers
      • Bron, France, 69677
        • Active, not recruiting
        • Hospices Civils de Lyon - Hôpital Louis Pradel
      • Lille, France, 59000
        • Active, not recruiting
        • Hôpital Jeanne de Flandre
      • Marseille, France, 13385
        • Active, not recruiting
        • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
      • Paris, France, 75012
        • Active, not recruiting
        • Hopital Armand Trousseau
      • Paris, France, 75019
        • Active, not recruiting
        • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
      • Toulouse, France, 31059
        • Completed
        • CHU de Toulouse - Hôpital des Enfants
  • Germany
      • Cologne, Germany, 50937
        • Active, not recruiting
        • Universitaetsklinikum Koeln
      • Leipzig, Germany, 04103
        • Active, not recruiting
        • Universitätsklinikum Leipzig
      • Ulm, Germany, 89075
        • Active, not recruiting
        • Universitaetsklinikum Ulm
  • Israel
      • Afula, Israel, 1834111
        • Active, not recruiting
        • Emek Medical Center
      • Beersheba, Israel, 8410101
        • Active, not recruiting
        • Soroka Medical Center
      • Haifa, Israel, 3109601
        • Active, not recruiting
        • Rambam Health Care Campus
      • Haifa, Israel, 3436212
        • Active, not recruiting
        • Carmel Hospital
      • Jerusalem, Israel, 9013102
        • Completed
        • Shaare Zedek Medical Center
      • Kfar Saba, Israel, 4428164
        • Active, not recruiting
        • Meir Medical Center
      • Petah Tikva, Israel, 4920235
        • Active, not recruiting
        • Schneider Children's Medical Center
      • Ramat Gan, Israel, 5262100
        • Active, not recruiting
        • Sheba Medical Center
  • Mexico
      • Aguascalientes, Mexico, 20129
        • Active, not recruiting
        • Centro de Atención e Investigación Clínica
      • Guadalajara, Mexico, 44260
        • Active, not recruiting
        • Centro de Investigacion Medica de Occidente, S.C.
      • Monterrey, Mexico, 64610
        • Active, not recruiting
        • Clínica García Flores SC
      • Monterrey, Mexico, 64060
        • Active, not recruiting
        • Christus - Latam Hub Center of Excellence and Innovation S.C.
      • Puebla City, Mexico, 72190
        • Active, not recruiting
        • Consultorio Médico de Endocrinología y Pediatría
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Completed
        • University Pediatric Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Active, not recruiting
        • Hospital Universitari Vall d'Hebron
      • Córdoba, Spain, 14004
        • Active, not recruiting
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28009
        • Active, not recruiting
        • Hospital Infantil Universitario Nino Jesus
      • Málaga, Spain, 29011
        • Active, not recruiting
        • H.R.U Málaga - Hospital General
      • Valencia, Spain, 46026
        • Active, not recruiting
        • Hospital Universitari i Politecnic La Fe
  • Taiwan
      • Taichung, Taiwan, 404332
        • Active, not recruiting
        • China Medical University Hospital
      • Tainan, Taiwan, 704
        • Active, not recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • Completed
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Active, not recruiting
        • Chang Gung Medical Foundation-Linkou Branch
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0SL
        • Active, not recruiting
        • Addenbrooke's Hospital
      • Glagow, United Kingdom, G51 4TF
        • Active, not recruiting
        • Royal Hospital for Children
      • Leeds, United Kingdom, LS1 3EX
        • Active, not recruiting
        • Leeds General Infirmary
      • Leicester, United Kingdom, LE1 5WW
        • Completed
        • Leicester Royal Infirmary
      • Liverpool, United Kingdom, L14 5AB
        • Completed
        • Alder Hey Children's Hospital
      • London, United Kingdom, WC1E 6DB
        • Completed
        • Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4PL
        • Active, not recruiting
        • Royal Victoria Infirmary
      • Sheffield, United Kingdom, S10 2TH
        • Active, not recruiting
        • Sheffield Children's Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Completed
        • Southampton General Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Active, not recruiting
        • Children's Hospital Los Angeles
      • Sacramento, California, United States, 95821
        • Active, not recruiting
        • Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Active, not recruiting
        • Nemours Children's Health - Delaware
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Active, not recruiting
        • Medical Research Partners
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Active, not recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Active, not recruiting
        • Indiana University Health University Hospital
    • New York
      • Buffalo, New York, United States, 14203
        • Active, not recruiting
        • UBMD Pediatrics
      • Syracuse, New York, United States, 13210
        • Active, not recruiting
        • SUNY Upstate Medical University
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Active, not recruiting
        • Driscoll Children's Hospital
      • DeSoto, Texas, United States, 75115
        • Active, not recruiting
        • Epic Medical Research - DeSoto
      • Fort Worth, Texas, United States, 76164
        • Active, not recruiting
        • Valley Institute of Research - Fort Worth
      • Shavano Park, Texas, United States, 78231
        • Active, not recruiting
        • Consano Clinical Research, LLC
      • Weslaco, Texas, United States, 78596
        • Active, not recruiting
        • Texas Valley Clinical Research
    • Utah
      • Layton, Utah, United States, 84041
        • Completed
        • Alliance for Multispecialty Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC).
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Placebo Comparator: Placebo
Participants will receive placebo SC.
Drug: Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 72
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
Time Frame: Baseline, Week 72
Baseline, Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 72
Baseline, Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 5%
Time Frame: Week 72
Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 10%
Time Frame: Week 72
Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 15%
Time Frame: Week 72
Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 20%
Time Frame: Week 72
Week 72
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 72
Baseline, Week 72
Percent Change from Baseline in Triglycerides
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)
Time Frame: Baseline, Week 72
Baseline, Week 72
Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 72
Baseline, Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18832
  • I8F-MC-GPIX (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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