A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2)

Obesity Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439277
• Other study ID #: 18832
• Secondary ID: I8F-MC-GPIX
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: June 2027

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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Gain

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	Fundación Respirar	Buenos Aires
Argentina	Investigaciones Medicas Imoba Srl	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	DIM Clínica Privada	Ramos Mejía	Buenos Aires
Argentina	Centro Medico Privado de Reumatologia	SAN M. DE Tucuman	Tucumán
Australia	Nightingale Research	Adelaide	South Australia
Australia	Cornerstone Dermatology	Coorparoo	Queensland
Australia	Perth Children's Hospital	Perth	Western Australia
Australia	University of Sydney - Charles Perkins Centre	Sydney	New South Wales
Canada	Alberta Children's Hospital Loc. 1	Calgary	Alberta
Canada	Hamilton Medical Research Group	Hamilton	Ontario
Canada	McGill University Health Centre	Montréal	Quebec
France	Centre Hospitalier Universitaire d'Angers	Angers	Maine-et-Loire
France	Hospices Civils de Lyon - Hopital Louis Pradel	Bron	Rhône
France	Hôpital Jeanne de Flandre	Lille	Nord-Pas-de-Calais
France	Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone	Marseille	Bouches-du-Rhône
France	Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T	Paris
France	Hôpital Armand Trousseau	Paris
France	CHU de Toulouse - Hôpital des Enfants	Toulouse	Haute-Garonne
Germany	Klinik und Poliklinik für Kinder- und Jugendmedizin pädiatrische Endokrinologie und Diabetologie	Köln	Nordrhein-Westfalen
Germany	Universitätsklinikum Leipzig	Leipzig	Sachsen
Germany	Universitaetsklinikum Ulm	Ulm	Baden-Württemberg
Israel	Emek Medical Center	Afula	HaTsafon
Israel	Soroka Medical Center	Be'er Sheva	HaDarom
Israel	Yitzhak Shamir Medical Center	Beer Yaacov	HaMerkaz
Israel	Pediatrics Endocrinology	Haifa	?eifa
Israel	Rambam Health Care Campus	Haifa	HaTsafon
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Meir Medical Center	Kfar Saba	HaMerkaz
Israel	Schneider Children's Medical Center	Petah-Tikva	HaMerkaz
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Mexico	Centro de Atención e Investigación Clínica	Aguascalientes
Mexico	Christus - Latam Hub Center of Excellence and Innovation S.C.	Monterrey	Nuevo León
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
Puerto Rico	University Pediatric Hospital	San Juan
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitario Reina Sofia	Cordoba	Andalucía
Spain	Hospital Infantil Universitario Niño Jesús	Madrid	Madrid, Comunidad De
Spain	Hospital Regional Universitario	Málaga
Spain	Hospital Universitari i Politecnic La Fe	València
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng-Kung Uni. Hosp.	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
United Kingdom	Women's and Children's Division Research Unit	Bristol	Bristol, City Of
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire
United Kingdom	Alder Hey Children's Hospital	Liverpool
United Kingdom	Paediatric and Adolescent OutpatientsElizabeth Garrett Anderson WingUniversity College Hospital	London	London, City Of
United Kingdom	University Hospital Southampton	Southampton	Hampshire
United States	UBMD Pediatrics	Buffalo	New York
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Indiana University Health University Hospital	Indianapolis	Indiana
United States	Alliance for Multispecialty Research, LLC	Layton	Utah
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Center Of Excellence in Diabetes and Endocrinology	Sacramento	California
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Texas Valley Clinical Research	Weslaco	Texas
United States	Nemours Children's Health - Delaware	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  France,  Germany,  Israel,  Mexico,  Puerto Rico,  Spain,  Taiwan,  United Kingdom, 

Outcome

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