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

NCT06439277 · tracked via the Priya Life Science UK tracker

Sponsor

Eli Lilly and Company

Phase

Phase 3

Started

2024-06-03

Last updated

2026-09-04

Condition(s) studied

ObesityWeight Gain

Investigational drug(s) / intervention(s)

TirzepatidePlacebo

Tirzepatide: Administered SC

Placebo: Administered SC

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

17 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (69)

Facility	City	Region	Status
Children's Hospital Los Angeles	Los Angeles	California	Active Not Recruiting
Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology	Sacramento	California	Active Not Recruiting
Nemours Children's Health - Delaware	Wilmington	Delaware	Active Not Recruiting
Medical Research Partners	Ammon	Idaho	Active Not Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	Active Not Recruiting
Indiana University Health University Hospital	Indianapolis	Indiana	Active Not Recruiting
UBMD Pediatrics	Buffalo	New York	Active Not Recruiting
SUNY Upstate Medical University	Syracuse	New York	Active Not Recruiting
Driscoll Children's Hospital	Corpus Christi	Texas	Active Not Recruiting
Epic Medical Research - DeSoto	DeSoto	Texas	Active Not Recruiting
Valley Institute of Research - Fort Worth	Fort Worth	Texas	Active Not Recruiting
Consano Clinical Research, LLC	Shavano Park	Texas	Active Not Recruiting
Texas Valley Clinical Research	Weslaco	Texas	Active Not Recruiting
Alliance for Multispecialty Research, LLC	Layton	Utah	Completed
Investigaciones Medicas Imoba Srl	Buenos Aires	Argentina	Active Not Recruiting
Centro de Investigaciones Metabólicas (CINME)	Buenos Aires	Argentina	Active Not Recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Buenos Aires	Argentina	Active Not Recruiting
Fundación Respirar	Buenos Aires	Argentina	Completed
DIM Clínica Privada	Ramos Mejía	Argentina	Active Not Recruiting
Centro de Investigaciones Médicas Tucuman	SAN M. de Tucuman	Argentina	Active Not Recruiting
Nightingale Research	Adelaide	Australia	Completed
Cornerstone Dermatology	Coorparoo	Australia	Active Not Recruiting
Perth Children's Hospital	Perth	Australia	Completed
University of Sydney - Charles Perkins Centre	Sydney	Australia	Active Not Recruiting
Winterberry Research Inc.	Hamilton	Canada	Recruiting
Premier Clinical Trial Network	Hamilton	Canada	Not Yet Recruiting
Bluewater Clinical Research Group Inc.	Sarnia	Canada	Completed
Centre Hospitalier Universitaire d'Angers	Angers	France	Active Not Recruiting
Hospices Civils de Lyon - Hopital Louis Pradel	Bron	France	Active Not Recruiting
Hôpital Jeanne de Flandre	Lille	France	Active Not Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone	Marseille	France	Active Not Recruiting
Hôpital Armand Trousseau	Paris	France	Active Not Recruiting
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T	Paris	France	Active Not Recruiting
CHU de Toulouse - Hôpital des Enfants	Toulouse	France	Completed
Universitaetsklinikum Koeln	Cologne	Germany	Active Not Recruiting
Universitätsklinikum Leipzig	Leipzig	Germany	Active Not Recruiting
Universitaetsklinikum Ulm	Ulm	Germany	Active Not Recruiting
Emek Medical Center	Afula	Israel	Active Not Recruiting
Soroka Medical Center	Beersheba	Israel	Active Not Recruiting
Rambam Health Care Campus	Haifa	Israel	Active Not Recruiting

+ 29 more sites — see the full list on the official registry below.

On this site

📄 Mounjaro (tirzepatide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06439277 on ClinicalTrials.gov ↗ ← All trials in the UK