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A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Sponsor: Eli Lilly and Company
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.
Official title: Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-10-16
Completion Date
2029-07
Last Updated
2025-06-25
Healthy Volunteers
No
Conditions
Interventions
Tirzepatide
Administered SC
Placebo
Administered SC
Locations (33)
CenExel iResearch, LLC
Decatur, Georgia, United States
Solaris Clinical Research
Meridian, Idaho, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Barry J. Reiner, MD, LLC
Baltimore, Maryland, United States
M Health Fairview - Delaware Clinical Research Unit (DCRU)
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Aventiv Research Inc
Columbus, Ohio, United States
PriMED Clinical Research
Dayton, Ohio, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, United States
Alberta Diabetes Institute
Edmonton, Alberta, Canada
The Wharton Medical Clinic Clinical Trials Inc
Hamilton, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
ReFit Clinic
Olomouc, Olomoucký kraj, Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, Ostrava Město, Czechia
Fakultni nemocnice v Motole
Prague, Praha 5, Czechia
Nemocnice Jihlava
Jihlava, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
Yitzhak Shamir Medical Center
Beer Yaacov, Central District, Israel
Schneider Children's Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Emek Medical Center
Afula, Northern District, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Soroka Medical Center
Beersheba, Southern District, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Veneto, Italy
Azienda Ospedaliera Universitaria Di Messina G. Martino
Messina, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, Italy
Instytut Diabetologii
Warsaw, Masovian Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Zabrze, Silesian Voivodeship, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Uniwersyteckie Centrum Pediatrii im. M. Konop -T
Lodz, Łódź Voivodeship, Poland