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

Last updated: May 20, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Placebo

Tirzepatide

Clinical Study ID

NCT06075667
17365
I8F-MC-GPHP
2023-504413-80-00
  • Ages 12-17
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have obesity, as defined by BMI equal to or above the 95th percentile for age andsex, on age- and sex-specific growth chart, OR

  • Have overweight, as defined by BMI equal to or above the 85th percentile but lessthan 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 withmetformin for at least 90 days prior to screening and have a HbA1c<9.0%

Exclusion

Exclusion Criteria:

  • Have a self-reported, or by parent or legal guardian where applicable, decrease inbody weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screeningirrespective of medical records.

  • Have Type 1 Diabetes

  • Have taken within 90 days before screening or intend to start prescribed orover-the-counter medications, or alternative remedies including herbal ornutritional supplements, intended to promote body weight reduction.

  • Are prepubertal (Tanner stage 1).

  • Have a family or personal history of medullary thyroid carcinoma (MTC) or MultipleEndocrine 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, suchas, 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.

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
October 16, 2023
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Alberta Diabetes Institute

    Edmonton, Alberta T6G 2E1
    Canada

    Site Not Available

  • The Wharton Medical Clinic Clinical Trials Inc

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Wharton Medical Clinic

    Hamilton, Ontario L8L 5G8
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • ReFit Clinic

    Olomouc, Olomoucký Kraj 779 00
    Czechia

    Active - Recruiting

  • Nemocnice AGEL Ostrava - Vitkovice a.s.

    Ostrava, Ostrava Město 703 84
    Czechia

    Completed

  • Fakultni nemocnice Motol

    Praha, Praha 5 15006
    Czechia

    Active - Recruiting

  • Fakultni nemocnice v Motole

    Praha, Praha 5 150 06
    Czechia

    Site Not Available

  • Nemocnice Jihlava

    Jihlava, 58633
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva, HaDarom 8410101
    Israel

    Active - Recruiting

  • Yitzhak Shamir Medical Center

    Be'er Ya'aqov, HaMerkaz 70300
    Israel

    Site Not Available

  • Yitzhak Shamir Medical Center

    Beer Yaacov, HaMerkaz 70300
    Israel

    Active - Recruiting

  • Schneider Children's Medical Center

    Petah-Tikva, HaMerkaz 4920235
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, HaMerkaz 5262100
    Israel

    Active - Recruiting

  • Emek Medical Center

    Afula, HaTsafon 1834111
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa, HaTsafon 3109601
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Yerushalayim 9013102
    Israel

    Active - Recruiting

  • IRCCS - AOU di Bologna

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, Emilia-Romagna 40138
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

    Verona, Veneto 37126
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Di Messina G. Martino

    Messina, 98125
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100
    Italy

    Site Not Available

  • Centro de Investigacion Medica de Occidente, S.C.

    Zapopan, Jalisco 44260
    Mexico

    Site Not Available

  • Clínica García Flores SC

    Monterrey, Nuevo León 64610
    Mexico

    Site Not Available

  • Centro de Atención e Investigación Clínica

    Aguascalientes, 20119
    Mexico

    Site Not Available

  • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

    Chihuahua, 31110
    Mexico

    Site Not Available

  • Consultorio Médico de Endocrinología y Pediatría

    Puebla, 72190
    Mexico

    Site Not Available

  • Instytut Diabetologii

    Warsaw, Mazowieckie 02-117
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdańsk, Pomorskie 80-952
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Łódź, Łódzkie 91-738
    Poland

    Active - Recruiting

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Uniwersyteckie Centrum Pediatrii im. M. Konop -T

    Łódź, Łódzkie 91-738
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

    Zabrze, Śląskie 41-800
    Poland

    Site Not Available

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Active - Recruiting

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • Barry J. Reiner, MD, LLC

    Baltimore, Maryland 21229
    United States

    Active - Recruiting

  • M Health Fairview - Delaware Clinical Research Unit (DCRU)

    Minneapolis, Minnesota 55414
    United States

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Aventiv Research Inc

    Columbus, Ohio 43213
    United States

    Active - Recruiting

  • PriMED Clinical Research

    Dayton, Ohio 45429
    United States

    Active - Recruiting

  • Vanderbilt Health One Hundred Oaks

    Nashville, Tennessee 372212
    United States

    Active - Recruiting

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