Clinical trial NCT05260021: A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With an Open-Label Extension Assessing the Efficacy, Safety, and Pharmacokinetics/Pharmacodynamics of Tirzepatide in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, or Basal Insulin, or Both
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type2 Diabetes
Diabetes Mellitus
Diabetes Mellitus, Type 2
T2D
T2DM (Type 2 Diabetes Mellitus)
Glucose Metabolism Disorders
Endocrine System Diseases
Metabolic Disease
Keywords: GLP-1 RA
Glucose-dependent insulinotropic polypeptide (GIP)
glucagon-like peptide-1 (GLP-1)
GIP/GLP-1 dual receptor agonist
Incretins
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 99
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both.

The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 10 to below 18 years at screening visit
* Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening.
* Have HbA1c \>6.5% to ≤11% at screening
* Have body weight ≥50 kilogram (kg) 110 pounds and BMI of \>85th percentile of the general age and gender-matched population for that country or region.

Exclusion Criteria:

* Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
* After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
* Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
* Had chronic or acute pancreatitis any time prior to study entry
* Female participants who are pregnant or breast feeding or intending to become pregnant.
* Using prescription or over the counter medications for weight loss within 90 days of the screening visit.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 30
Secondary outcomes:
measure: Change from Baseline in HbA1c (Individual Doses)
timeFrame: Baseline, Week 30
measure: Percent Change from Baseline in BMI
timeFrame: Baseline, Week 30
measure: Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (age and sex-matched)
timeFrame: Baseline, Week 30
measure: Change From Baseline in Fasting Serum Glucose (FSG)
timeFrame: Baseline, Week 30
measure: Percentage of Participants Who Achieve ≤6.5% of HbA1c
timeFrame: Week 30
measure: Percentage of Participants Who Achieve <7.0% of HbA1c
timeFrame: Week 30
measure: Percentage of Participants Who Achieve <5.7% of HbA1c
timeFrame: Week 30
measure: Change From Baseline for Serum Lipid Levels
timeFrame: Baseline, Week 30
measure: Change From Baseline in Height Standard Deviation Score (SDS)
timeFrame: Baseline, Week 30
measure: Change From Baseline in Weight SDS
timeFrame: Baseline, Week 30
measure: Pharmacokinetics (PK): Area Under the Concentration Curve (AUC), Steady State (ss) of Tirzepatide
timeFrame: Baseline to Week 30
measure: Change From Baseline in PedsQL Generic Core Scale
timeFrame: Baseline, Week 52
measure: Change From Baseline PedsQL (3.2) Diabetic Module
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Sacramento
country: United States
facility: Center Of Excellence in Diabetes and Endocrinology
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Vallejo
country: United States
facility: Touro University California
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Wilmington
country: United States
facility: Nemours Children's Health - Delaware
state: Delaware
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: Flint
country: United States
facility: AA Medical Research Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia (CHOP)
state: Pennsylvania
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Brisbane
country: Australia
facility: Centre for Children's Health Research
state: Queensland
city: Perth
country: Australia
facility: Perth Children's Hospital
state: Western Australia
city: Vitória
country: Brazil
facility: CEDOES
state: Espírito Santo
city: Curitiba
country: Brazil
facility: Centro de Diabetes Curitiba
state: Paraná
city: Passo Fundo
country: Brazil
facility: Instituto Méderi de Pesquisa e Saúde
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Instituto da Crianca com Diabetes
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Campinas
country: Brazil
facility: Instituto de Pesquisa clinica de Campinas
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto de Pesquisa Clinica
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto da Crianca do Hospital das Clinicas da FMUSP
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
state: Maine-et-Loire
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universitaire (C -T
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
city: Ahmedabad
country: India
facility: Gujarat Endocrin Pvt Ltd
state: Gujarat
city: Bangalore
country: India
facility: M S Ramaiah Medical College and Hospitals
state: Karnataka
city: Thane
country: India
facility: Bhakti Vedanta Hospital and Research Institute
state: Maharashtra
city: Coimbatore
country: India
facility: Kovai Diabetes Speciality Center and Hospital
state: Tamil Nadu
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education & Research
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
state: HaDarom
city: Be'er Ya'aqov
country: Israel
facility: Yitzhak Shamir Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: HaTsafon
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Yerushalayim
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" Piazza Luigi Miraglia, 2 Napoli Campa -T
state: Campania
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
state: Veneto
city: Ancona
country: Italy
facility: Ospedale Pediatrico Salesi
city: San Nicolás de los Garza
country: Mexico
facility: Unidad Médica para la Salud Integral
state: Nuevo León
city: Tampico
country: Mexico
facility: Clínica Cemain
state: Tamaulipas
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo Sc
city: Puebla
country: Mexico
facility: Consultorio Médico de Endocrinología y Pediatría
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: Kingston Upon Hull
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
state: Leicestershire
Study officials:
affiliation: Eli Lilly and Company
name: 1-877-CTLilly (1877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: