Clinical trial NCT06439277: A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)
Official title: Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Weight Gain
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 300
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 goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. The study will last approximately 76 weeks and may include up to 23 visits.

Detailed description: The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.

Eligibility criteria: Inclusion Criteria:

* Have body mass index (BMI) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia.
* Have history of at least 1 self-reported unsuccessful dietary effort to lose weight.
* Are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable).

Exclusion Criteria:

* Have undergone or plan to undergo a 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.
* Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state
* Have type 2 diabetes or have a HbA1c \> 6.4% at screening
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

Primary outcomes:
measure: Percent Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 72
measure: A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of New Predefined Comorbidity or Worsening of Existing Predefined Comorbidity
timeFrame: Baseline, Week 72
Secondary outcomes:
measure: Percentage of Participants Who Achieve BMI Reduction of ≥ 5%
timeFrame: Week 72
measure: Percentage of Participants Who Achieve BMI Reduction of ≥ 10%
timeFrame: Week 72
measure: Percentage of Participants Who Achieve BMI Reduction of ≥ 15%
timeFrame: Week 72
measure: Percentage of Participants Who Achieve BMI Reduction of ≥ 20%
timeFrame: Week 72
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 72
measure: Percent Change from Baseline in Triglycerides
timeFrame: Baseline, Week 72
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 72
measure: Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI)
timeFrame: Baseline, Week 72
measure: Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA)
timeFrame: Baseline, Week 72
measure: Change from Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 72
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 72
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 72
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Sacramento
country: United States
facility: Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology
state: California
city: Wilmington
country: United States
facility: Nemours Children's Health - Delaware
state: Delaware
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Buffalo
country: United States
facility: UBMD Pediatrics
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Weslaco
country: United States
facility: Texas Valley Clinical Research
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Utah
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigaciones Medicas Imoba Srl
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: SAN M. DE Tucuman
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Newcastle
country: Australia
facility: Hunter Medical Research Institute
state: New South Wales
city: Sydney
country: Australia
facility: University of Sydney - Charles Perkins Centre
state: New South Wales
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Coorparoo
country: Australia
facility: Cornerstone Dermatology
state: Queensland
city: Adelaide
country: Australia
facility: Nightingale Research
state: South Australia
city: Perth
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Ajax
country: Canada
facility: Kids Clinic
state: Ontario
city: Hamilton
country: Canada
facility: Winterberry Research Inc.
state: Ontario
city: Hamilton
country: Canada
facility: Premier Clinical Trial Network
state: Ontario
city: Sarnia
country: Canada
facility: Bluewater Clinical Research Group Inc.
state: Ontario
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
state: Bouches-du-Rhône
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital des Enfants
state: Haute-Garonne
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
state: Maine-et-Loire
city: Lille
country: France
facility: Hôpital Jeanne de Flandre
state: Nord-Pas-de-Calais
city: Bron
country: France
facility: Hospices Civils de Lyon - Hopital Louis Pradel
state: Rhône
city: Paris
country: France
facility: Hôpital Armand Trousseau
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden-Württemberg
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
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: Kfar Saba
country: Israel
facility: Meir 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: Haifa
country: Israel
facility: Carmel Hospital
state: Ḥeifā
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medica de Occidente, S.C.
state: Jalisco
city: Monterrey
country: Mexico
facility: Christus - Latam Hub Center of Excellence and Innovation S.C.
state: Nuevo León
city: Monterrey
country: Mexico
facility: Clínica García Flores SC
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Centro de Atención e Investigación Clínica
city: Puebla
country: Mexico
facility: Consultorio Médico de Endocrinología y Pediatría
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
state: Madrid, Comunidad De
city: Málaga
country: Spain
facility: H.R.U Málaga - Hospital General
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambridgeshire
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: London
country: United Kingdom
facility: Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital
state: London, City Of
city: Glagow
country: United Kingdom
facility: Royal Hospital for Children
state: Scotland
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
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: