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

Obesity Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075667
• Other study ID #: 17365
• Secondary ID: I8F-MC-GPHP2023-
• Status: Recruiting
• Phase: Phase 3
• Start date: October 16, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Canada	CIUSSS- saguenay-Lac-Saint-Jean	Chicoutimi	Quebec
Canada	Alberta Diabetes Institute	Edmonton	Alberta
Canada	Wharton Medical Clinic	Hamilton	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Czechia	Nemocnice Jihlava	Jihlava
Czechia	ReFit Clinic	Olomouc	Olomoucký Kraj
Czechia	Nemocnice AGEL Ostrava - Vitkovice a.s.	Ostrava	Ostrava Mesto
Czechia	Fakultni nemocnice Motol	Praha	Praha 5
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Israel	Emek Medical Center	Afula	HaTsafon
Israel	Soroka Medical Center	Be'er Sheva	HaDarom
Israel	Yitzhak Shamir Medical Center	Beer Yaacov	HaMerkaz
Israel	Rambam Health Care Campus	Haifa	HaTsafon
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Schneider Children's Medical Center	Petah-Tikva	HaMerkaz
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Italy	IRCCS - AOU di Bologna	Bologna	Emilia-Romagna
Italy	Azienda Ospedaliera Universitaria Di Messina G. Martino	Messina
Italy	Azienda Ospedaliero Universitaria Maggiore della Carità	Novara
Italy	Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento	Verona	Veneto
Mexico	Centro de Atención e Investigación Clínica	Aguascalientes
Mexico	Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos	Chihuahua
Mexico	Clínica García Flores SC	Monterrey	Nuevo León
Mexico	Consultorio Médico de Endocrinología y Pediatría	Puebla
Mexico	Centro de Investigacion Medica de Occidente, S.C.	Zapopan	Jalisco
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk	Pomorskie
Poland	Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Lódz	Lódzkie
Poland	Instytut Diabetologii	Warsaw	Mazowieckie
Poland	Samodzielny Publiczny Szpital Kliniczny nr 1 SUM	Zabrze	Slaskie
United States	Barry J. Reiner, MD, LLC	Baltimore	Maryland
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Aventiv Research Inc	Columbus	Ohio
United States	PriMED Clinical Research	Dayton	Ohio
United States	CenExel iResearch, LLC	Decatur	Georgia
United States	Solaris Clinical Research	Meridian	Idaho
United States	M Health Fairview - Delaware Clinical Research Unit (DCRU)	Minneapolis	Minnesota
United States	Vanderbilt Health One Hundred Oaks	Nashville	Tennessee
United States	Washington University	Saint Louis	Missouri
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Israel,  Italy,  Mexico,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Body Mass Index (BMI)		Baseline, Week 72
Secondary	Percentage of Participants with =5% BMI Reduction		Baseline, Week 72
Secondary	Change from Baseline in Body Weight		Baseline, Week 72
Secondary	Change from Baseline in Waist Circumference		Baseline, Week 72
Secondary	Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score		Baseline, Week 72
Secondary	Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts		Baseline, Week 72
Secondary	Change from Baseline in Systolic Blood Pressure		Baseline, Week 72
Secondary	Change from Baseline in Diastolic Blood Pressure		Baseline, Week 72
Secondary	Percent Change from Baseline in Total Cholesterol		Baseline, Week 72
Secondary	Change from Baseline in Fasting Glucose		Baseline, Week 72
Secondary	Change from Baseline in Fasting Insulin		Baseline, Week 72
Secondary	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.	Baseline through Week 72

External Links

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