Clinical trial • Phase III • Endocrinology
TIRZEPATIDE for Obesity
Phase III trial of TIRZEPATIDE for Obesity.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Obesity
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 27-05-2024
- First CTIS Authorization Date
- 05-09-2024
Trial design
Randomised, placebo to match ly3298176 injection (placebo injection matching tirzepatide once-weekly schedule as stated in the title)-controlled Phase III trial in France, Germany, Spain.
- Randomised
- Yes
- Comparator
- Placebo to match LY3298176 injection (placebo injection matching tirzepatide once-weekly schedule as stated in the title)
- Target Sample Size
- 164
Eligibility
Recruits 164 paediatric patients.
- Vulnerable Population
- Participants are adolescents (minors) aged 12-17; age-appropriate assent and consent documents are provided (Assent 12-17, Main ICF for 16-17 yrs, Parent ICFs). Subject information and ICF templates, addenda (prescreening, sub-study), and study partner/OLE ICFs are available, indicating parental/guardian consent plus participant assent processes. Translated ICF/assent versions (e.g. DE, ES, TC and other redacted translations) and addenda are provided.
Inclusion criteria
- {"criterion_text":"- Be 12 to 17 years"}
- {"criterion_text":"- Have a BMI equal to or above the 95th percentile for age and sex on CDC-NCHS 2022"}
Exclusion criteria
- {"criterion_text":"- Have Type 1 Diabetes"}
- {"criterion_text":"- Have Type 2 Diabetes"}
- {"criterion_text":"- Have had or plan to have a surgical treatment for obesity"}
- {"criterion_text":"- Have history of an inflamed pancreas (pancreatitis)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percent Change from Baseline in Body Mass Index (BMI)","definition_or_measurement_approach":"Percent change from baseline in BMI"}
- {"endpoint_text":"- A Composite Endpoint of Normalization or Clinically Significant Improvement in At Least 2 Predefined Weight-Related Comorbidities Present at Screening Without Development of a New Predefined Comorbidity Or Worsening of an Existing Predefined Comorbidity","definition_or_measurement_approach":"Composite of normalization or clinically significant improvement in at least 2 predefined weight-related comorbidities present at screening, without development of a new predefined comorbidity or worsening of an existing predefined comorbidity"}
Recruitment
- Planned Sample Size
- 164
- Recruitment Window Months
- 31
- Consent Approach
- Parental/guardian consent and participant assent processes are used for minors: dedicated Assent form for 12-17, Parent ICF(s), Main ICF for 16-17 yrs and for 18 yrs, addenda for prescreening and sub-studies, study partner and OLE ICFs. Documents include translated versions (e.g. DE, ES, TC) and redacted/public versions.
Methods
- Recruitment materials and arrangements: posters, brochures/clinical-trial brochures (including CYP-specific brochure), school note, visit card, certificate of participation, thank you (screening/participation/dropout/end of study) materials, study guide, ancillary supplies and appreciation items (K2 materials), and recruitment arrangements document (K1).
- Use of patient cards and retention/visit cards and participant guides (including WatchPat Participant Guide) as part of subject engagement.
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 47
France
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 614
- Number Of Sites
- 8
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Pediatrie multidisciplinaire -Endocrinologie
- Principal Investigator Name
- Rachel Reynaud
- Principal Investigator Email
- rachel.reynaud@ap-hm.fr
- Contact Person Name
- Rachel Reynaud
- Contact Person Email
- rachel.reynaud@ap-hm.fr
- Site Name
- Hospital Femme Mere Enfant
- Department Name
- Centre d’Investigation Clinique
- Principal Investigator Name
- Marc Nicolino
- Principal Investigator Email
- marc.nicolino@chu-lyon.fr
- Contact Person Name
- Marc Nicolino
- Contact Person Email
- marc.nicolino@chu-lyon.fr
- Site Name
- Hopital Des Enfants
- Department Name
- endocrinologie, gynécologie et génétique médicale
- Principal Investigator Name
- Beatrice Jouret
- Principal Investigator Email
- jouret.b@chu-toulouse.fr
- Contact Person Name
- Beatrice Jouret
- Contact Person Email
- jouret.b@chu-toulouse.fr
- Site Name
- Trousseau Hospital
- Department Name
- Nutrition et gastroentérologie pédiatrique
- Principal Investigator Name
- Beatrice Dubern
- Principal Investigator Email
- beatrice.dubern@aphp.fr
- Contact Person Name
- Beatrice Dubern
- Contact Person Email
- beatrice.dubern@aphp.fr
- Site Name
- Robert Debre University Hospital
- Department Name
- Centre d'Investigations Cliniques
- Principal Investigator Name
- Jean-Claude Carel
- Principal Investigator Email
- jean-claude.carel@aphp.fr
- Contact Person Name
- Jean-Claude Carel
- Contact Person Email
- jean-claude.carel@aphp.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Pediatrie
- Principal Investigator Name
- Regis Coutant
- Principal Investigator Email
- recoutant@chu-angers.fr
- Contact Person Name
- Regis Coutant
- Contact Person Email
- recoutant@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Centre d'investigation clinique - Antenne Pédiatrique
- Principal Investigator Name
- Iva Gueorguieva
- Principal Investigator Email
- iva.hubert@chu-lille.fr
- Contact Person Name
- Iva Gueorguieva
- Contact Person Email
- iva.hubert@chu-lille.fr
- Site Name
- Centre Hospitalier Regional De Marseille (duplicate entry if present)
- Department Name
- Pediatrie multidisciplinaire -Endocrinologie
- Principal Investigator Name
- Rachel Reynaud
- Principal Investigator Email
- rachel.reynaud@ap-hm.fr
- Contact Person Name
- Rachel Reynaud
- Contact Person Email
- rachel.reynaud@ap-hm.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 05-09-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 543
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Department of Pediatrics
- Principal Investigator Name
- Antje Körner
- Principal Investigator Email
- antje.koerner@medizin.uni-leipzig.de
- Contact Person Name
- Antje Körner
- Contact Person Email
- antje.koerner@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Kinder- und Jugendmedizin
- Principal Investigator Name
- Martin Wabitsch
- Principal Investigator Email
- martin.wabitsch@uniklinik-ulm.de
- Contact Person Name
- Martin Wabitsch
- Contact Person Email
- martin.wabitsch@uniklinik-ulm.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik und Poliklinik für Kinder- und Jugendmedizin pädiatrische Endokrinologie und Diabetologie
- Principal Investigator Name
- Miriam Jackels
- Principal Investigator Email
- miriam.jackels@uk-koeln.de
- Contact Person Name
- Miriam Jackels
- Contact Person Email
- miriam.jackels@uk-koeln.de
Spain
- Earliest CTIS Part Ii Submission Date
- 29-08-2024
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 552
- Number Of Sites
- 7
- Number Of Participants
- 22
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Endocrinology
- Principal Investigator Name
- Andreea Ciudin
- Principal Investigator Email
- andreea.ciudin@vallhebron.cat
- Contact Person Name
- Andreea Ciudin
- Contact Person Email
- andreea.ciudin@vallhebron.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Pediatric Endocrinology
- Principal Investigator Name
- Maria Francisca Moreno Macian
- Principal Investigator Email
- morenoframac@gmail.com
- Contact Person Name
- Maria Francisca Moreno Macian
- Contact Person Email
- morenoframac@gmail.com
- Site Name
- Hospital Universitario Virgen del Rocio
- Department Name
- Endocrinology
- Principal Investigator Name
- Constanza Navarro Moreno
- Principal Investigator Email
- constanza.navarro.sspa@juntadeandalucia.es
- Contact Person Name
- Constanza Navarro Moreno
- Contact Person Email
- constanza.navarro.sspa@juntadeandalucia.es
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Endocrinology
- Principal Investigator Name
- Gabriel Angel Martos-Moreno
- Principal Investigator Email
- gabrielangel.martos@salud.madrid.org
- Contact Person Name
- Gabriel Angel Martos-Moreno
- Contact Person Email
- gabrielangel.martos@salud.madrid.org
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Pediatric Endocrinology
- Principal Investigator Name
- Isabel Leiva
- Principal Investigator Email
- isabeleivag@gmail.com
- Contact Person Name
- Isabel Leiva
- Contact Person Email
- isabeleivag@gmail.com
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Pediatric Endocrinology
- Principal Investigator Name
- Ana Belen Ariza-Jimenez
- Principal Investigator Email
- micodemas@hotmail.com
- Contact Person Name
- Ana Belen Ariza-Jimenez
- Contact Person Email
- micodemas@hotmail.com
- Site Name
- Hospital Universitario Virgen del Rocio (duplicate/other campus if present)
- Department Name
- Endocrinology
- Principal Investigator Name
- Constanza Navarro Moreno
- Principal Investigator Email
- constanza.navarro.sspa@juntadeandalucia.es
- Contact Person Name
- Constanza Navarro Moreno
- Contact Person Email
- constanza.navarro.sspa@juntadeandalucia.es
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Codes: 1; 15 (Site Readiness); 4
- Name
- Icon Clinical Research Limited
- Responsibilities
- Code: 4
- Name
- Fortrea Inc.
- Responsibilities
- Code: 4
- Name
- Parexel International Corp.
- Responsibilities
- Code: 4
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- Code: 4
- Name
- WCG Clinical Inc.
- Responsibilities
- Code: 15 (Study Training)
Third parties
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Sponsor duties: code 6","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties: code 1; code 15 (Site Readiness); code 4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties: code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Sponsor duties: code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"CQ Fluency","duties_or_roles":"Sponsor duties: code 15 (Standard Translations)","organisation_type":"Health care"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"Sponsor duties: code 6","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"The Hibbert Co.","duties_or_roles":"Sponsor duties: code 15 (Distribution of Recruitment and Retention items)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Sponsor duties: code 15 (Study Training)","organisation_type":"Industry"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Sponsor duties: code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Tier 1 Impact Pbc Inc.","duties_or_roles":"Sponsor duties: code 15 (Study Training)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Sponsor duties: code 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Tirzepatide
- Active Substance
- TIRZEPATIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised
- Frequency
- Once weekly (trial title: once weekly)
- Investigational Product Name
- Placebo to match LY3298176 injection
- Modality
- Other
- Frequency
- Once weekly (placebo matched to active schedule)
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