DRUG
Tirzepatide
Administered SC
A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Status
Recruiting
Phase
Phase 3
Enrollment
300
Locations
72
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Administered SC
Timeline
From registration to results.
First posted
Jun 3, 2024
Study start
Jun 3, 2024
Primary completion
Oct 2027
Study completion
Dec 2030
Results posted
Not reported
Registry updated
Jul 20, 2026
Outcomes
What the study measures.
Primary outcomes
Percent Change from Baseline in Body Mass Index (BMI)
Time frame · 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
Secondary outcomes
Percentage of Participants Who Achieve BMI Reduction of ≥ 5%
Time frame · Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 10%
Time frame · Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 15%
Time frame · Week 72
Percentage of Participants Who Achieve BMI Reduction of ≥ 20%
Time frame · Week 72
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame · Baseline, Week 72
Percent Change from Baseline in Triglycerides
Time frame · Baseline, Week 72
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame · Baseline, Week 72
Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)
Time frame · 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
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame · Baseline, Week 72
Eligibility
Who can take part.
- Minimum age
- 12 Years
- Maximum age
- 17 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
72 registered sites.
Argentina · Australia · Canada · France · Germany · Israel · Mexico · Puerto Rico · Spain · Taiwan · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Children's Hospital Los Angeles
Los Angeles, California, United States
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
Sacramento, California, United States
Nemours Children's Health - Delaware
Wilmington, Delaware, United States
Medical Research Partners
Ammon, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
UBMD Pediatrics
Buffalo, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Epic Medical Research - DeSoto
DeSoto, Texas, United States
Valley Institute of Research - Fort Worth
Fort Worth, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Texas Valley Clinical Research
Weslaco, Texas, United States
Alliance for Multispecialty Research, LLC
Layton, Utah, United States
Investigaciones Medicas Imoba Srl
Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina
Fundación Respirar
Buenos Aires, Argentina
DIM Clínica Privada
Ramos Mejía, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Argentina
Nightingale Research
Adelaide, Australia
Cornerstone Dermatology
Coorparoo, Australia
Hunter Medical Research Institute
Newcastle, Australia
Perth Children's Hospital
Perth, Australia
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Tirzepatide.
NCT IDStudyPhase / statusEnrollmentUpdated
Fibrosis Lessens After Metabolic Surgery
The Cleveland Clinic · Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) · Non-Alcoholic Fatty Liver Disease
Phase 4
Recruiting
120
2026-07
Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Obesity & Overweight
Not applicable
Recruiting
24
2026-07
Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity
Shahid Beheshti University of Medical Sciences · Heart Failure and Reduced Ejection Fraction · Obesity & Overweight
Phase 3
Not yet recruiting
60
2026-07
Tirzepatide Impact Assessment Study
Texas Tech University · Obesity & Overweight · Cardiometabolic Health Indicators
Not applicable
Recruiting
27
2026-07
Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion
Alaa Sada · Mild Autonomous Cortisol Secretion (MACS) · Adrenalectomy; Status
Phase 2
Recruiting
34
2026-07
Bariatric Surgery Combined With GLP-1RA: A Multicenter Study.
China-Japan Friendship Hospital · Obesity
Not applicable
Recruiting
400
2026-07
Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial
yifang zhu · Acute Ischemic Stroke (AIS)
Phase 2 / Phase 3
Not yet recruiting
430
2026-07
Tirzepatide for Treatment of CCCA
Johns Hopkins University · Central Centrifugal Cicatricial Alopecia (CCCA)
Phase 2
Not yet recruiting
20
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.