Clinical trial NCT06075667: A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or 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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percent Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 72
Secondary outcomes:
measure: Percentage of Participants with ≥5% BMI Reduction
timeFrame: Baseline, Week 72
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 72
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 72
measure: Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score
timeFrame: Baseline, Week 72
measure: Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts
timeFrame: Baseline, Week 72
measure: Change from Baseline in Systolic Blood Pressure
timeFrame: Baseline, Week 72
measure: Change from Baseline in Diastolic Blood Pressure
timeFrame: Baseline, Week 72
measure: Percent Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 72
measure: Change from Baseline in Fasting Glucose
timeFrame: Baseline, Week 72
measure: Change from Baseline in Fasting Insulin
timeFrame: Baseline, Week 72
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide
timeFrame: Baseline through Week 72
Other outcomes:
Locations:
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology
state: Kansas
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Baltimore
country: United States
facility: Barry J. Reiner, MD, LLC
state: Maryland
city: Minneapolis
country: United States
facility: M Health Fairview - Delaware Clinical Research Unit (DCRU)
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Dayton
country: United States
facility: PriMED Clinical Research
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Health One Hundred Oaks
state: Tennessee
city: Edmonton
country: Canada
facility: Alberta Diabetes Institute
state: Alberta
city: Hamilton
country: Canada
facility: The Wharton Medical Clinic Clinical Trials Inc
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS- saguenay-Lac-Saint-Jean
state: Quebec
city: Olomouc
country: Czechia
facility: ReFit Clinic
state: Olomoucký Kraj
city: Ostrava
country: Czechia
facility: Nemocnice AGEL Ostrava - Vitkovice a.s.
state: Ostrava Město
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole
state: Praha 5
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: HaDarom
city: Beer Yaacov
country: Israel
facility: Yitzhak Shamir Medical Center
state: HaMerkaz
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Afula
country: Israel
facility: Emek Medical Center
state: HaTsafon
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: HaTsafon
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
state: Emilia-Romagna
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
state: Veneto
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria Di Messina G. Martino
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità
city: Warsaw
country: Poland
facility: Instytut Diabetologii
state: Mazowieckie
city: Łódź
country: Poland
facility: Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Uniwersyteckie Centrum Pediatrii im. M. Konop -T
state: Łódzkie
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
state: Śląskie
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: