Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
211
Countries
3
Sites
16
Obesity
1. To demonstrate that tirzepatide MTD is superior to placebo for achieving BMI reduction. 2. To demonstrate that tirzepatide MTD is superior to placebo for improvement in weight-related comorbidities.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 27 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507655-30-00
- WHO UTN
- U1111-1307-8914
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Therapy, Safety
1. To demonstrate that tirzepatide MTD is superior to placebo for achieving BMI reduction.
2. To demonstrate that tirzepatide MTD is superior to placebo for improvement in weight-related comorbidities.
Conditions and MedDRA coding
Obesity
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Be 12 to 17 years
- Have a BMI equal to or above the 95th percentile for age and sex on CDC-NCHS 2022
Exclusion criteria 4
- Have Type 1 Diabetes
- Have Type 2 Diabetes
- Have had or plan to have a surgical treatment for obesity
- Have history of an inflamed pancreas (pancreatitis)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percent Change from Baseline in Body Mass Index (BMI)
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD7107375 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107378 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107376 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107377 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107379 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107380 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo to match LY3298176 injection
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Yprime LLC ORG-100042888
|
Malvern, United States | Data management |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Other, Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Fortrea Inc. ORG-100012602
|
Durham, United States | Laboratory analysis |
| CQ Fluency ORL-000007633
|
Hackensack, NJ, United States | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
| WCG Clinical Inc. ORL-000007439
|
Indianapolis, United States | Other |
| Parexel International Corp. ORG-100007310
|
Durham, United States | Laboratory analysis |
| Tier 1 Impact Pbc Inc. ORG-100050163
|
Covington, United States | Other |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Laboratory analysis |
Locations
3 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 10 | 7 |
| Germany | Ongoing, recruitment ended | 15 | 3 |
| Spain | Ongoing, recruitment ended | 22 | 6 |
| Rest of world
Israel, United Kingdom, Taiwan, Mexico, Australia, Argentina, United States, Canada
|
— | 164 | — |
Investigational sites
Centre Hospitalier Universitaire D'Angers
Pediatrie, 4 Rue Larrey, 49100, Angers
Hopital Des Enfants
endocrinologie, gynécologie et génétique médicale, 330 Avenue De Grande Bretagne, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Lille
Centre d'investigation clinique - Antenne Pédiatrique, Avenue Eugene Avinee, 59037, Lille Cedex
Centre Hospitalier Regional De Marseille
Pediatrie multidisciplinaire -Endocrinologie, 264 Rue Saint Pierre, 13005, Marseille
Hospital Femme Mere Enfant
Centre d’Investigation Clinique, 52 Boulevard Pinel, 69500, Bron
Robert Debre University Hospital
Centre d'Investigations Cliniques, 48 Boulevard Serurier, 75019, Paris
Trousseau Hospital
Nutrition et gastroentérologie pédiatrique, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
Universitaetsklinikum Ulm AöR
Klinik für Kinder- und Jugendmedizin, Eythstrasse 24, Mitte, Ulm
Universitaetsklinikum Leipzig AöR
Department of Pediatrics, Liebigstrasse 20, Zentrum-Suedost, Leipzig
University Hospital Cologne AöR
Klinik und Poliklinik für Kinder- und Jugendmedizin pädiatrische Endokrinologie und Diabetologie, Kerpener Strasse 62, Lindenthal, Cologne
Hospital Infantil Universitario Nino Jesus
Endocrinology, Avenida Menendez Pelayo 65, 28009, Madrid
Hospital Universitario Y Politecnico La Fe
Pediatric Endocrinology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Vall D Hebron
Endocrinology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Regional De Malaga
Pediatric Endocrinology, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Virgen del Rocio
Endocrinology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Reina Sofia
Pediatric Endocrinology, Avenida Menendez Pidal S/n, 14004, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-10-07 | 2024-12-18 | 2026-01-05 | ||
| Germany | 2024-10-29 | 2024-11-05 | 2026-01-05 | ||
| Spain | 2024-09-27 | 2024-10-08 | 2026-01-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 88 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-507655-30-00_Redacted | e |
| Protocol (for publication) | D4_Patient Document Copyright Template | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_v1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Ancillary Supplies | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Certificate Participation | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material School Note | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Study Guide | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Thank You Dropout | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Thank You End Of Study | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Thank You Participation | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Thank You Screening | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Visit Card | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Appreciation items | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Certificate-Participation_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Certificate-Participation_Master_v1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical-Trial-Brochure_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical-Trial-Brochure-CYP_Master_v1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_v1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_School-Note_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_School-Note_Master_v1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study-Guide_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-Dropout_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-Dropout_Master_v1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-End_Of_Study_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-End_Of_Study_Master_v1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-Participation_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-Participation_Master_v1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-Screening_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank-You-Screening_Master_v1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Visit-Card_Master_ES | 1.0 |
| Subject information and informed consent form (for publication) | L1_ ICF_Assent Form_DE_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Addendum Future Research_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Addendum Prescreening TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Addendum Prescreening_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Addendum Sub Study_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adults_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent 12-17 TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent 12-17_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Assent OLE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF OLE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Parents TC_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Parents_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Study Partner_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum prescreening_Assent | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum prescreening_Parent | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum sub-study_Assent_b_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum sub-study_Assent_Redacted | c |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum sub-study_Parent_b_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum sub-study_Parent_redacted | c |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum sub-study_Parent_Redacted | C |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum sub-study_Patient_b_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Addendum sub-study_Patient_redacted | c |
| Subject information and informed consent form (for publication) | L1_ICF_Assent form_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Adult_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_Parent_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_16-17 yrs old_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_18 yrs old_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Parent_DE_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_OLE Assent Form_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_OLE Main ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_Pre-screening ICF addendum | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE_adults_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE_Assent_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE_parents_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study partner | 1.0 |
| Subject information and informed consent form (for publication) | L1_Study Partner ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2 Patient cards | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material Subject Instructions for Use | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material WatchPat Participant Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Ancillary list_v1 | 1 |
| Subject information and informed consent form (for publication) | L2_Direction for Use IFU_v1_05Feb2024 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_WatchPat app_DE | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_WatchPat Participant Guide_v1 | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Card Template_v1 | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Study-Guide_Master_v1 | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Visit-Card_Master_v1_19Apr2024_DE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-507655-30-00_DE_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-507655-30-00_ENG_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-507655-30-00_ES_redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-507655-30-00_ES_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507655-30-00_FR_Redacted | e |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-27 | Germany | Acceptable 2024-09-03
|
2024-09-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-13 | Acceptable | 2024-10-10 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-18 | Germany | Acceptable | 2024-09-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-10 | Acceptable | 2024-11-15 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-15 | Germany | 2024-11-15 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-14 | Acceptable | 2025-03-28 | |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-18 | Germany | Acceptable | 2025-06-18 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-07-15 | Germany | Acceptable 2025-08-27
|
2025-08-28 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-17 | Germany | Acceptable | 2025-11-07 |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-01-19 | Germany | Acceptable 2026-02-27
|
2026-03-02 |