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)

Overview

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. Participants who have completed the primary 72-week GPIX study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

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.

Interventions

• Drug Tirzepatide
  Administered SC
• Drug Placebo
  Administered SC

Primary outcome measures

• Percent Change from Baseline in Body Mass Index (BMI) [Time frame: Baseline, Week 72]
• 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 [Time frame: Baseline, Week 72]

Secondary outcome measures (12)

• Percentage of Participants Who Achieve BMI Reduction of ≥ 5% [Time frame: Week 72]
• Percentage of Participants Who Achieve BMI Reduction of ≥ 10% [Time frame: Week 72]
• Percentage of Participants Who Achieve BMI Reduction of ≥ 15% [Time frame: Week 72]
• Percentage of Participants Who Achieve BMI Reduction of ≥ 20% [Time frame: Week 72]
• Change from Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Week 72]
• Percent Change from Baseline in Triglycerides [Time frame: Baseline, Week 72]
• Change from Baseline in Systolic Blood Pressure (SBP) [Time frame: Baseline, Week 72]
• Change from Baseline in Peripheral Apnea-Hypopnea Index (pAHI) [Time frame: Baseline, Week 72]
• Percent Change from Baseline in Total Body Fat Mass as Determined by Dual energy X-ray Absorptiometry (DXA) [Time frame: Baseline, Week 72]
• Change from Baseline in Diastolic Blood Pressure (DBP) [Time frame: Baseline, Week 72]
• Percent Change from Baseline in Body Weight [Time frame: Baseline, Week 72]
• Change from Baseline in Waist Circumference [Time frame: Baseline, Week 72]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 14 centers

• Children's Hospital Los Angeles — Los Angeles
• Sutter Valley Medical Foundation (SVMF) Pediatric Endocrinology — Sacramento
• Nemours Children's Health - Delaware — Wilmington
• Medical Research Partners — Ammon
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
• Indiana University Health University Hospital — Indianapolis
• UBMD Pediatrics — Buffalo
• SUNY Upstate Medical University — Syracuse
• … and 6 more centers

United Kingdom · 9 centers

• Addenbrooke's Hospital — Cambridge
• Royal Hospital for Children — Glagow
• Leeds General Infirmary — Leeds
• Leicester Royal Infirmary — Leicester
• Alder Hey Children's Hospital — Liverpool
• Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hos — London
• Royal Victoria Infirmary — Newcastle upon Tyne
• Sheffield Children's Hospital — Sheffield
• … and 1 more center

Israel · 8 centers

• Emek Medical Center — Afula
• Soroka Medical Center — Beersheba
• Rambam Health Care Campus — Haifa
• Carmel Hospital — Haifa
• Shaare Zedek Medical Center — Jerusalem
• Meir Medical Center — Kfar Saba
• Schneider Children's Medical Center — Petah Tikva
• Sheba Medical Center — Ramat Gan

France · 7 centers

• Centre Hospitalier Universitaire d'Angers — Angers
• Hospices Civils de Lyon - Hopital Louis Pradel — Bron
• Hôpital Jeanne de Flandre — Lille
• Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone — Marseille
• Hôpital Armand Trousseau — Paris
• Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo — Paris
• CHU de Toulouse - Hôpital des Enfants — Toulouse

Argentina · 6 centers

• Investigaciones Medicas Imoba Srl — Buenos Aires
• Centro de Investigaciones Metabólicas (CINME) — Buenos Aires
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires
• Fundación Respirar — Buenos Aires
• DIM Clínica Privada — Ramos Mejía
• Centro de Investigaciones Médicas Tucuman — SAN M. de Tucuman

Australia · 5 centers

• Nightingale Research — Adelaide
• Cornerstone Dermatology — Coorparoo
• Hunter Medical Research Institute — Newcastle
• Perth Children's Hospital — Perth
• University of Sydney - Charles Perkins Centre — Sydney

Mexico · 5 centers

• Centro de Atención e Investigación Clínica — Aguascalientes
• Centro de Investigacion Medica de Occidente, S.C. — Guadalajara
• Christus - Latam Hub Center of Excellence and Innovation S.C. — Monterrey
• Clínica García Flores SC — Monterrey
• Consultorio Médico de Endocrinología y Pediatría — Puebla City

Spain · 5 centers

• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Universitario Reina Sofia — Córdoba
• Hospital Infantil Universitario Niño Jesús — Madrid
• H.R.U Málaga - Hospital General — Málaga
• Hospital Universitari i Politecnic La Fe — Valencia

Taiwan · 4 centers

• China Medical University Hospital — Taichung
• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Chang Gung Medical Foundation-Linkou Branch — Taoyuan

Canada · 3 centers

• Winterberry Research Inc. — Hamilton
• Premier Clinical Trial Network — Hamilton
• Bluewater Clinical Research Group Inc. — Sarnia

Germany · 3 centers

• Universitaetsklinikum Koeln — Cologne
• Universitätsklinikum Leipzig — Leipzig
• Universitaetsklinikum Ulm — Ulm

Puerto Rico · 1 center

• University Pediatric Hospital — San Juan

Identifiers

NCT: NCT06439277 · 18832 · I8F-MC-GPIX

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗