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)
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, Canada, Czechia, Israel, Italy, Mexico, Poland,
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 |
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