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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06075667
Collaborator
(none)
150
Enrollment
36
Locations
2
Arms
37.6
Anticipated Duration (Months)
4.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Oct 15, 2023
Anticipated Primary Completion Date :
Feb 14, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

Participants will receive tirzepatide subcutaneously (SC).

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change from Baseline in Body Mass Index (BMI) [Baseline, Week 72]

    Secondary Outcome Measures

    1. Percentage of Participants with ≥5% BMI Reduction [Baseline, Week 72]

    2. Change from Baseline in Body Weight [Baseline, Week 72]

    3. Change from Baseline in Waist Circumference [Baseline, Week 72]

    4. Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score [Baseline, Week 72]

    5. Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts [Baseline, Week 72]

    6. Change from Baseline in Systolic Blood Pressure [Baseline, Week 72]

    7. Change from Baseline in Diastolic Blood Pressure [Baseline, Week 72]

    8. Percent Change from Baseline in Total Cholesterol [Baseline, Week 72]

    9. Change from Baseline in Fasting Glucose [Baseline, Week 72]

    10. Change from Baseline in Fasting Insulin [Baseline, Week 72]

    11. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide [Baseline through Week 72]

      AUC is presented as a single average measure of AUC across the study duration.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CenExel iResearch, LLC Decatur Georgia United States 30030
    2 Solaris Clinical Research Meridian Idaho United States 83646
    3 Cotton O'Neil Clinical Research Center Topeka Kansas United States 66606
    4 Pennington Biomedical Research Center Baton Rouge Louisiana United States 70808
    5 Barry J. Reiner, MD, LLC Baltimore Maryland United States 21229
    6 M Health Fairview - Delaware Clinical Research Unit (DCRU) Minneapolis Minnesota United States 55414
    7 Aventiv Research Inc Columbus Ohio United States 43213
    8 PriMED Clinical Research Dayton Ohio United States 45429
    9 Vanderbilt Health One Hundred Oaks Nashville Tennessee United States 37204
    10 Alberta Diabetes Institute Edmonton Alberta Canada T6G 2E1
    11 Wharton Medical Clinic Hamilton Ontario Canada L8L 5G8
    12 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    13 CIUSSS- saguenay-Lac-Saint-Jean Chicoutimi Quebec Canada G7H 5H6
    14 ReFit Clinic Olomouc Olomoucký Kraj Czechia 779 00
    15 Nemocnice AGEL Ostrava - Vitkovice a.s. Ostrava Ostrava Město Czechia 703 84
    16 Nemocnice Jihlava Jihlava Czechia 58633
    17 Fakultni nemocnice Kralovske Vinohrady Praha 10 Czechia 100 34
    18 Soroka Medical Center Be'er Sheva HaDarom Israel 8410101
    19 Yitzhak Shamir Medical Center Be'er Ya'aqov HaMerkaz Israel 70300
    20 Schneider Children's Medical Center Petah-Tikva HaMerkaz Israel 4920235
    21 Emek Medical Center Afula HaTsafon Israel 1834111
    22 Rambam Health Care Campus Haifa HaTsafon Israel 3109601
    23 Shaare Zedek Medical Center Jerusalem Yerushalayim Israel 9013102
    24 IRCCS - AOU di Bologna Bologna Emilia-Romagna Italy 40138
    25 Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento Verona Veneto Italy 37126
    26 Azienda Ospedaliera Universitaria Di Messina G. Martino Messina Italy 98125
    27 Azienda Ospedaliero Universitaria Maggiore della Carità Novara Italy 28100
    28 Centro de Investigacion Medica de Occidente, S.C. Zapopan Jalisco Mexico 44260
    29 Clínica García Flores SC Monterrey Nuevo León Mexico 64610
    30 Centro de Atención e Investigación Clínica Aguascalientes Mexico 20129
    31 Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos Chihuahua Mexico 31110
    32 Consultorio Médico de Endocrinología y Pediatría Puebla Mexico 72190
    33 Instytut Diabetologii Warsaw Mazowieckie Poland 02-117
    34 Uniwersyteckie Centrum Kliniczne Gdańsk Pomorskie Poland 80-952
    35 Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Łódź Łódzkie Poland 91-738
    36 Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze Śląskie Poland 41-800

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT06075667
    Other Study ID Numbers:
    • 17365
    • I8F-MC-GPHP
    • 2023-504413-80-00
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Obesity
    Overweight
    Tirzepatide

    Study Results

    No Results Posted as of Oct 12, 2023