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Clinical Trials in the USA / NCT06075667
Active, not recruiting Phase 3

A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

NCT06075667 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2023-10-16
Last updated
2026-06-29

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

Tirzepatide →Placebo

Tirzepatide: Administered SC

Placebo: Administered SC

Study summary

The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits.

Participants who have completed the primary 72-week GPHP 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
No
Inclusion Criteria: * Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR * Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity. * dyslipidemia * pre-hypertension * hypertension * nonalcoholic fatty liver disease * obstructive sleep apnea * prediabetes * documented preexisting condition of Type 2 Diabetes Participants with Type 2 Diabetes Mellitus (T2DM) * Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c\<9.0% Exclusion Criteria: * Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records. * Have Type 1 Diabetes * Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction. * Are prepubertal (Tanner stage 1). * Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2 * Have a history of chronic or acute pancreatitis. * Have undergone or plan to undergo 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.

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
CenExel iResearch, LLC Decatur Georgia
Solaris Clinical Research Meridian Idaho
Cotton O'Neil Diabetes & Endocrinology Topeka Kansas
Pennington Biomedical Research Center Baton Rouge Louisiana
Barry J. Reiner, MD, LLC Baltimore Maryland
M Health Fairview - Delaware Clinical Research Unit (DCRU) Minneapolis Minnesota
Washington University School of Medicine St Louis Missouri
Aventiv Research Inc Columbus Ohio
PriMED Clinical Research Dayton Ohio
Vanderbilt Health One Hundred Oaks Nashville Tennessee
Alberta Diabetes Institute Edmonton Alberta
The Wharton Medical Clinic Clinical Trials Inc Hamilton Ontario
The Hospital for Sick Children Toronto Ontario
CIUSSS- saguenay-Lac-Saint-Jean Chicoutimi Quebec
ReFit Clinic Olomouc Olomouc Region
Nemocnice AGEL Ostrava - Vitkovice a.s. Ostrava Ostrava Město
Fakultni nemocnice v Motole Prague Praha 5
Nemocnice Jihlava Jihlava Czechia
Fakultni nemocnice Kralovske Vinohrady Prague Czechia
Yitzhak Shamir Medical Center Beer Yaacov Central District
Schneider Children's Medical Center Petah Tikva Central District
Sheba Medical Center Ramat Gan Central District
Shaare Zedek Medical Center Jerusalem Jerusalem
Emek Medical Center Afula Northern District
Rambam Health Care Campus Haifa Northern District
Soroka Medical Center Beersheba Southern District
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola Bologna Emilia-Romagna
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento Verona Veneto
Azienda Ospedaliera Universitaria Di Messina G. Martino Messina Italy
Azienda Ospedaliero Universitaria Maggiore della Carità Novara Italy
Instytut Diabetologii Warsaw Masovian Voivodeship
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze Silesian Voivodeship
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Uniwersyteckie Centrum Pediatrii im. M. Konop -T Lodz Łódź Voivodeship

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 NCT06075667 on ClinicalTrials.gov ↗ ← All trials in the USA