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

Primary Purpose

Obesity, Overweight

Status
Not yet recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CenExel iResearch, LLC
  • Solaris Clinical Research
  • Cotton O'Neil Clinical Research Center
  • Pennington Biomedical Research Center
  • Barry J. Reiner, MD, LLC
  • M Health Fairview - Delaware Clinical Research Unit (DCRU)
  • Aventiv Research Inc
  • PriMED Clinical Research
  • Vanderbilt Health One Hundred Oaks
  • Alberta Diabetes Institute
  • Wharton Medical Clinic
  • The Hospital for Sick Children
  • CIUSSS- saguenay-Lac-Saint-Jean
  • ReFit Clinic
  • Nemocnice AGEL Ostrava - Vitkovice a.s.
  • Nemocnice Jihlava
  • Fakultni nemocnice Kralovske Vinohrady
  • Soroka Medical Center
  • Yitzhak Shamir Medical Center
  • Schneider Children's Medical Center
  • Emek Medical Center
  • Rambam Health Care Campus
  • Shaare Zedek Medical Center
  • IRCCS - AOU di Bologna
  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
  • Azienda Ospedaliera Universitaria Di Messina G. Martino
  • Azienda Ospedaliero Universitaria Maggiore della Carità
  • Centro de Investigacion Medica de Occidente, S.C.
  • Clínica García Flores SC
  • Centro de Atención e Investigación Clínica
  • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
  • Consultorio Médico de Endocrinología y Pediatría
  • Instytut Diabetologii
  • Uniwersyteckie Centrum Kliniczne
  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
  • Samodzielny Publiczny Szpital Kliniczny nr 1 SUM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tirzepatide

Placebo

Arm Description

Participants will receive tirzepatide subcutaneously (SC).

Participants will receive placebo.

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Body Mass Index (BMI)

Secondary Outcome Measures

Percentage of Participants with ≥5% BMI Reduction
Change from Baseline in Body Weight
Change from Baseline in Waist Circumference
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score
Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts
Change from Baseline in Systolic Blood Pressure
Change from Baseline in Diastolic Blood Pressure
Percent Change from Baseline in Total Cholesterol
Change from Baseline in Fasting Glucose
Change from Baseline in Fasting Insulin
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
AUC is presented as a single average measure of AUC across the study duration.

Full Information

First Posted
October 4, 2023
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT06075667
Brief Title
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
February 14, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide subcutaneously (SC).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percent Change from Baseline in Body Mass Index (BMI)
Time Frame
Baseline, Week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants with ≥5% BMI Reduction
Time Frame
Baseline, Week 72
Title
Change from Baseline in Body Weight
Time Frame
Baseline, Week 72
Title
Change from Baseline in Waist Circumference
Time Frame
Baseline, Week 72
Title
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score
Time Frame
Baseline, Week 72
Title
Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts
Time Frame
Baseline, Week 72
Title
Change from Baseline in Systolic Blood Pressure
Time Frame
Baseline, Week 72
Title
Change from Baseline in Diastolic Blood Pressure
Time Frame
Baseline, Week 72
Title
Percent Change from Baseline in Total Cholesterol
Time Frame
Baseline, Week 72
Title
Change from Baseline in Fasting Glucose
Time Frame
Baseline, Week 72
Title
Change from Baseline in Fasting Insulin
Time Frame
Baseline, Week 72
Title
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
Description
AUC is presented as a single average measure of AUC across the study duration.
Time Frame
Baseline through Week 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
CenExel iResearch, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Contact:
Phone
404-537-1281
First Name & Middle Initial & Last Name & Degree
Kimball A. Johnson
Facility Name
Solaris Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Contact:
Phone
208-288-0123
First Name & Middle Initial & Last Name & Degree
David J. Butuk
Facility Name
Cotton O'Neil Clinical Research Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Glenn Wynne
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Contact:
Phone
225-763-2831
First Name & Middle Initial & Last Name & Degree
Daniel Hsia
Facility Name
Barry J. Reiner, MD, LLC
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Contact:
Phone
410-646-4009
First Name & Middle Initial & Last Name & Degree
Barry J Reiner
Facility Name
M Health Fairview - Delaware Clinical Research Unit (DCRU)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Contact:
Phone
612-626-6616
First Name & Middle Initial & Last Name & Degree
Claudia K. Fox
Facility Name
Aventiv Research Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Contact:
Phone
614-501-6164
First Name & Middle Initial & Last Name & Degree
Sridhar Guduri
Facility Name
PriMED Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Contact:
Phone
937-534-4201
First Name & Middle Initial & Last Name & Degree
Rogelio Amisola
Facility Name
Vanderbilt Health One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Facility Contact:
Phone
225-226-5662
First Name & Middle Initial & Last Name & Degree
Gitanjali Srivastava
Facility Name
Alberta Diabetes Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Maria HAQQ
Facility Name
Wharton Medical Clinic
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Contact:
Phone
19055238134
First Name & Middle Initial & Last Name & Degree
Sean Wharton
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Hamilton
Facility Name
CIUSSS- saguenay-Lac-Saint-Jean
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcel Milot
Facility Name
ReFit Clinic
City
Olomouc
State/Province
Olomoucký Kraj
ZIP/Postal Code
779 00
Country
Czechia
Facility Contact:
Phone
420734423510
First Name & Middle Initial & Last Name & Degree
Dalibor Pastucha
Facility Name
Nemocnice AGEL Ostrava - Vitkovice a.s.
City
Ostrava
State/Province
Ostrava Město
ZIP/Postal Code
703 84
Country
Czechia
Facility Contact:
Phone
420724649902
First Name & Middle Initial & Last Name & Degree
Jan Bozensky
Facility Name
Nemocnice Jihlava
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Contact:
Phone
420567157736
First Name & Middle Initial & Last Name & Degree
Pavel Vlachy
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Contact:
Phone
00420267162561
First Name & Middle Initial & Last Name & Degree
Irena Aldhoon Hainerova
Facility Name
Soroka Medical Center
City
Be'er Sheva
State/Province
HaDarom
ZIP/Postal Code
8410101
Country
Israel
Facility Contact:
Phone
97286244150
First Name & Middle Initial & Last Name & Degree
Alon Haim
Facility Name
Yitzhak Shamir Medical Center
City
Beer Yaacov
State/Province
HaMerkaz
ZIP/Postal Code
70300
Country
Israel
Facility Contact:
Phone
972537346636
First Name & Middle Initial & Last Name & Degree
Marianna Rachmiel
Facility Name
Schneider Children's Medical Center
City
Petah-Tikva
State/Province
HaMerkaz
ZIP/Postal Code
4920235
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip
Facility Name
Emek Medical Center
City
Afula
State/Province
HaTsafon
ZIP/Postal Code
1834111
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alina German
Facility Name
Rambam Health Care Campus
City
Haifa
State/Province
HaTsafon
ZIP/Postal Code
3109601
Country
Israel
Facility Contact:
Phone
97247774807
First Name & Middle Initial & Last Name & Degree
Nehama Zuckerman-Levin
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9013102
Country
Israel
Facility Contact:
Phone
97226666062
First Name & Middle Initial & Last Name & Degree
Floris Levy-Khademi
Facility Name
IRCCS - AOU di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulio Maltoni
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Facility Contact:
Phone
0458127662
First Name & Middle Initial & Last Name & Degree
Claudio Maffeis
Facility Name
Azienda Ospedaliera Universitaria Di Messina G. Martino
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Contact:
Phone
390902212121
First Name & Middle Initial & Last Name & Degree
Malgorzata Gabriela Wasniewska
Facility Name
Azienda Ospedaliero Universitaria Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Contact:
Phone
3903213733350
First Name & Middle Initial & Last Name & Degree
Ivana Rabbone
Facility Name
Centro de Investigacion Medica de Occidente, S.C.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
44260
Country
Mexico
Facility Contact:
Phone
523312044280
First Name & Middle Initial & Last Name & Degree
Emilia Susana Pelayo Orozco
Facility Name
Clínica García Flores SC
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64610
Country
Mexico
Facility Contact:
Phone
528183482015
First Name & Middle Initial & Last Name & Degree
Pedro Alberto Garcia
Facility Name
Centro de Atención e Investigación Clínica
City
Aguascalientes
ZIP/Postal Code
20129
Country
Mexico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Choza Romero
Facility Name
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
City
Chihuahua
ZIP/Postal Code
31110
Country
Mexico
Facility Contact:
Phone
526144398618
First Name & Middle Initial & Last Name & Degree
Luis Alejandro Nevarez
Facility Name
Consultorio Médico de Endocrinología y Pediatría
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Facility Contact:
Phone
522222657319
First Name & Middle Initial & Last Name & Degree
Margarita Barrientos
Facility Name
Instytut Diabetologii
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-117
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Ewa Pankowska
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malgorzata Szmigiero-Kawko
Facility Name
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
91-738
Country
Poland
Facility Contact:
Phone
48607145644
First Name & Middle Initial & Last Name & Degree
Agnieszka Szadkowska
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
City
Zabrze
State/Province
Śląskie
ZIP/Postal Code
41-800
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Zachurzok

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/427361
Description
A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities

Learn more about this trial

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

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