A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040) A Study of Orforglipron (LY3502970) in Adolescent Participants With Obesity, or Overweight With Related Comorbidities

2024-514081-40-00 Protocol JAM-MC-PWMP, -PW01 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 6 Jun 2025 · Status Ongoing, recruitment ended · 2 EU/EEA countries · 8 sites · Protocol JAM-MC-PWMP, -PW01

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 125
Countries 2
Sites 8

Obesity, Overweight

To demonstrate that orforglipron is superior to placebo for achieving BMI (Body Mass Index) reduction

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
6 Jun 2025 → ongoing
Decision date (initial)
2025-03-12
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Eli Lilly & Co.

External identifiers

EU CT number
2024-514081-40-00
WHO UTN
U1111-1312-0179

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Pharmacodynamic

To demonstrate that orforglipron is superior to placebo for achieving BMI (Body Mass Index) reduction

Conditions and MedDRA coding

Obesity, Overweight

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
EMA paediatric investigation plan (PIP)
EMEA-003299-PIP02-22
Plan to share IPD
Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. 1. Have been diagnosed with obesity or overweight with at least one weight-related comorbidity (abnormal lipids, high blood pressure, fatty liver disease, sleep apnea, prediabetes, or type 2 diabetes)
  2. 2. Have not been able to lose weight with healthy diet and physical activity

Exclusion criteria 5

  1. 1. Be prepubertal (have not started puberty)
  2. 2. Have lost more than 5 kg (11 pounds) in the 90 days before screening
  3. 3. Have type 1 diabetes
  4. 4. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2
  5. 5. Have had or plan to have a weight loss surgery during the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Percent Change from Baseline in Body Mass Index (BMI) [Time Frame: Baseline, Week 72]

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Orforglipron

PRD10193663 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193655 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193651 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193676 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193674 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Orforglipron

PRD10193667 · Product

Active substance
Orforglipron Hemicalcium
Substance synonyms
Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form
CAPSULE
Route of administration
ORAL USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
1 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to match LY3502970

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.

137 Total trials 45 Recruiting 84 Ended
Commercial
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 5

OrganisationCity, countryDuties
Bioclinica Inc.
ORG-100033079
 Philadelphia, United States Other
PPD Development LP
ORG-100011560
 Wilmington, United States On site monitoring, Code 11, Code 12, Code 2, Laboratory analysis, Code 5, Data management
Clinical Ink Inc.
ORG-100042433
 Winston Salem, United States Other
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States E-data capture
PPD Global Central Labs
ORG-100046496
 Zaventem, Belgium Laboratory analysis

Locations

2 EU/EEA countries · 8 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ongoing, recruitment ended 6 4
Poland Ongoing, recruiting 5 4
Rest of world
Japan, Israel, United Kingdom, Mexico, China, Brazil, United States
 — 114 —

Investigational sites

Italy

4 sites · Ongoing, recruitment ended
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Pediatria, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ospedaliera Universitaria Meyer IRCCS
SOC Diabetologia e Endocrinologia SS di Auxo-endocrinologia, Viale Gaetano Pieraccini 24, 50139, Florence
Azienda Ospedaliera Universitaria Integrata Verona
Ospedale della Donna e del bambino, Ospedale Borgo Trento - UOC Pediatria B, Piazzale Aristide Stefani 1, 37126, Verona
Ospedale Pediatrico Bambino Gesu
UOC Trials-Sviluppo e implementazione farmaci,vaccini e dispositivi medici per uso pediatrico, Piazza Di Sant'onofrio 4, 00165, Rome

Poland

4 sites · Ongoing, recruiting
Futuremeds Sp. z o.o.
n/a, Ul. Sw. Wincentego 93/7, 03-291, Warsaw
Instytut Diabetologii Sp. z o.o.
n/a, Ul. Raclawicka 129/2u, 02-117, Warsaw
Futuremeds Sp. z o.o.
n/a, Ul. Legnicka 16, 53-673, Wroclaw
Krakowskie Centrum Medyczne Sp. z o.o.
n/a, Ul. Mikolaja Kopernika 32 St, 31-501, Cracow

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2025-06-06 2025-06-18 2025-08-22
Poland 2025-06-06 2025-06-11

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Eli Lilly_J4M-MC-PW01_ISA1 Protocol_2024-514081-40-00_Public c
Protocol (for publication) D1_Eli Lilly_J4M-MC-PW01_Protocol Clarification Letter 1_2024-514081-40-00_Public n/a
Protocol (for publication) D1_Eli Lilly_J4M-MC-PW01_Protocol Clarification Letter 2_2024-514081-40-00_ n/a
Protocol (for publication) D1_Eli Lilly_J4M-MC-PW01_Protocol Clarification Letter_2024-514081-40-00_Public n/a
Protocol (for publication) D1_Eli Lilly_J4M-MC-PWMP_Master Protocol_2024-514081-40-00_Public Amd a
Recruitment arrangements (for publication) K1_ J4M-MC-PWMP_ J4M-MC-PW01_Recruitment-Arrangements_IT_Public n/a
Recruitment arrangements (for publication) K1_J4M-MC-PWMP_Recruitment-Informed-Consent-Procedure_PL_Polish_Public n/a
Subject information and informed consent form (for publication) L1_ J4M-MC-PW01_Adult-Pregnant-Partner-ICF_IT_Italian_Public 1.1
Subject information and informed consent form (for publication) L1_ J4M-MC-PW01_Genetic-Testing-ICF-Adult-Parent_ IT_Italian_Public 1.1
Subject information and informed consent form (for publication) L1_ J4M-MC-PW01_Parent-Pregnant-Partner-ICF_IT_Italian_Public 1.1
Subject information and informed consent form (for publication) L1_ J4M-MC-PW01_Pregnant-Partner-Assent-12-17-yr _IT_Italian_Public 1.1
Subject information and informed consent form (for publication) L1_ J4M-MC-PW01_Privacy-Addendum- Adult-Parent _IT_Italian_Public 2.0
Subject information and informed consent form (for publication) L1_J4M-MC_PWMP_ICF-Main-Adult-Parental_PL_Polish_Public 2.1
Subject information and informed consent form (for publication) L1_J4M-MC-PW01_Assent-12-17-yr_ IT_Italian_Public 2.0
Subject information and informed consent form (for publication) L1_J4M-MC-PW01_ICF-Genetic-testing-13-17_PL_Polish_Public 1.1
Subject information and informed consent form (for publication) L1_J4M-MC-PW01_ICF-Genetic-testing-Adult-Parental_PL_Polish_Public 1.1
Subject information and informed consent form (for publication) L1_J4M-MC-PW01_ICF-Main_Adult-Parental_PL_Polish_Public 3.1
Subject information and informed consent form (for publication) L1_J4M-MC-PW01_ICF-Main-13-17_PL_Polish_Public 2.1
Subject information and informed consent form (for publication) L1_J4M-MC-PW01_ICF-Main-Adult-Parental_PL_Polish_Public 3.0
Subject information and informed consent form (for publication) L1_J4M-MC-PW01_ICF-Main-Booklet-under-13_PL_Polish_Public 2.1
Subject information and informed consent form (for publication) L1_J4M-MC-PW01_ICF-Pregnant_PL_Polish_Public 1.1
Subject information and informed consent form (for publication) L1_J4M-MC-PW01_Main_ICF_Adult_Parent_ IT_Italian_Public 3.0
Subject information and informed consent form (for publication) L1_J4M-MC-PWMP_Assent-12-17-yr_ IT_Italian_Public 1.1
Subject information and informed consent form (for publication) L1_J4M-MC-PWMP_ICF_Main-13-17_PL_Polish_Public 1.1
Subject information and informed consent form (for publication) L1_J4M-MC-PWMP_ICF_Prescreening-Parental_PL_Polish_Public 2.0
Subject information and informed consent form (for publication) L1_J4M-MC-PWMP_ICF-Prescreening-13-17_PL_Polish_Public 1.1
Subject information and informed consent form (for publication) L1_J4M-MC-PWMP_ICF-Prescreening-under-13_PL_Polish_Public 1.1
Subject information and informed consent form (for publication) L1_J4M-MC-PWMP_Main-ICF-Adult-Parent_IT_Italian_Public 2.0
Subject information and informed consent form (for publication) L1_J4M-MC-PWMP_Prescreening-assent-12-17-yr_IT_Italian_Public 1.1
Subject information and informed consent form (for publication) L1_J4M-MC-PWMP_Prescreening-ICF-Parent_IT_Italian_Public 2.0
Subject information and informed consent form (for publication) L1_J4M-MC-PWMP_Privacy-Addendum_ Adult_Parent _IT_Italian_Public 2.0
Synopsis of the protocol (for publication) D2_Eli Lilly_J4M-MC-PW01_ISA1 Protocol Synopsis_2024-514081-40-00_EN_Public Amd a
Synopsis of the protocol (for publication) D2_Eli Lilly_J4M-MC-PW01_ISA1 Protocol Synopsis_2024-514081-40-00_IT_Public Amd a
Synopsis of the protocol (for publication) D2_Eli Lilly_J4M-MC-PW01_ISA1 Protocol Synopsis_2024-514081-40-00_PO_Public Amd a
Synopsis of the protocol (for publication) D2_Eli Lilly_J4M-MC-PWMP_Master Protocol Synopsis_2024-514081-40-00_EN_Public Amd a
Synopsis of the protocol (for publication) D2_Eli Lilly_J4M-MC-PWMP_Master Protocol Synopsis_2024-514081-40-00_IT_Public Amd a
Synopsis of the protocol (for publication) D2_Eli Lilly_J4M-MC-PWMP_Master Protocol Synopsis_2024-514081-40-00_PO_Public Amd a
Synopsis of the protocol (for publication) D4_Eli Lilly_J4M-MC-PW01_Patient Facing Document Copyright Statement_Public n/a

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-30 Italy Acceptable with conditions
2025-03-10
 2025-03-12
2 SUBSTANTIAL MODIFICATION SM-1 2025-03-27 Italy Acceptable
2025-05-29
 2025-05-29
3 NON SUBSTANTIAL MODIFICATION NSM-1 2025-06-24 Italy Acceptable
2025-05-29
 2025-06-24
4 SUBSTANTIAL MODIFICATION SM-2 2025-08-15 Acceptable 2025-11-06

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