Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,400
Countries
2
Sites
12
GZP1, GZP2: Obesity, Overweight GZP2: Type 2 Diabetes
GZPO: The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1 …
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 15 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-521098-14-00
- WHO UTN
- U1111-1317-8166
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
GZPO: The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1 (do not have type 2 diabetes) or J2A-MC-GZP2 (have type 2 diabetes).
GZP1: The main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO.
GZP2: The main purpose of this study is to see how orforglipron, compared with placebo, helps improve glycemic control in participants with obesity or with overweight and type 2 diabetes. This trial is part of the master protocol study J2A-MC-GZPO.
Conditions and MedDRA coding
GZP1, GZP2: Obesity, Overweight GZP2: Type 2 Diabetes
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- (GZP1) Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening: • hypertension • dyslipidemia • obstructive sleep apnea, or • cardiovascular disease
- (GZP1) Have a history of at least one unsuccessful dietary effort to lose body weight
- (GZP2) Have body mass index (BMI) ≥25 kilograms per square meter (kg/m2) at screening
- (GZP2) Have type 2 diabetes
- (GZP2) Have hemoglobin A1c (HbA1c) ≥7% and ≤10% at screening
- (GZP2) Have a history of at least one unsuccessful dietary effort to lose body weight
Exclusion criteria 6
- (GZP1) Have type 1 diabetes, type 2 diabetes, or any other types of diabetes
- (GZP2) Have type 1 diabetes
- (GZP1, GZP2) Have an unstable body weight within 90 days prior to screening
- (GZP1, GZP2) Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening
- (GZP1, GZP2) Have acute or chronic hepatitis or pancreatitis
- (GZP1, GZP2) Are taking other medications or alternative remedies to manage weight loss
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- (GZPO) Number of Participants Allocated to Each Study [Time Frame: Baseline to Week 4]
- (GZP1) Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 40]
- (GZP2) Change from Baseline in Hemoglobin A1c (HbA1c) [Time Frame: Baseline, Week 40]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD12263030 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263031 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263028 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263032 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263027 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263029 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
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 14
| Organisation | City, country | Duties |
|---|---|---|
| Lionbridge AG ORL-000012316
|
Basel, Switzerland | Other |
| Fisher Clinical Services, by Thermo Fisher Scientific ORL-000014176
|
Swedesboro, United States | Other |
| IQVIA Limited ORG-100008655
|
Livingston, United Kingdom | Laboratory analysis, Code 5 |
| Tier 1 Impact Pbc Inc. ORG-100050163
|
Covington, United States | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Code 11 |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Aparito Limited ORG-100026728
|
Wrexham, United Kingdom | E-data capture |
| Clariness GmbH ORG-100045306
|
Hamburg, Germany | Code 2 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| IQVIA ORL-000013395
|
Durham NC, United States | On site monitoring, Code 2, Interactive response technologies (IRT) |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Code 13 |
| Clario ORL-000006643
|
Philadelphia, United States | Laboratory analysis |
| OneStudyTeam ORL-000002046
|
Boston, United States | Code 2 |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Code 2 |
Locations
2 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 80 | 5 |
| Germany | Ongoing, recruitment ended | 157 | 7 |
| Rest of world
Mexico, Japan, United States, India, Argentina, China
|
— | 1,163 | — |
Investigational sites
Nemocnice Cesky Krumlov a.s.
Interní oddělení, Nemocnicni 429, 381 01, Horni Brana
Milan Kvapil s.r.o.
Diabetologická ambulance, Michnova 1622/4, Chodov, Prague
Medical Plus s.r.o.
N/A, Obchodni 1507, 686 01, Uherske Hradiste
MUDr. Alena Váchová
Diabetologie a obezitologie, Lékařský dům Géčko, České Vrbné 2403, České Budějovice
Donmed s.r.o.
Interní, diabetologická a cévní ambulance, Chittussiho 1001/9, Slezska Ostrava, Ostrava
Ambenet GmbH Das Ambulante Behandlungsnetz
N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Medizentrum Essen Borbeck
Medizentrum, Huelsmannstrasse 6, Borbeck, Essen
Medicover GmbH
Neuroendokrinologie, Orleansplatz 3, Au-Haidhausen, Munich
Diabetes-Zentrum-Wilhelmsburg GbR
Diabetes Zentrum, Krieterstrasse 30, Wilhelmsburg, Hamburg
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
RED-Institut, Markt 15, 23758, Oldenburg In Holstein
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut
N/A, Gerhard-Ellrodt-Str. 19, 04249, Leipzig
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 |
|---|---|---|---|---|---|
| Czechia | 2025-08-15 | 2025-08-25 | 2026-01-12 | ||
| Germany | 2025-08-15 | 2025-08-18 | 2026-01-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 55 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Master Protocol 2025-521098-14-00 GZPO_Redacted | c |
| Protocol (for publication) | D1_Sub-protocol 2025-521098-14-00 GZP1_Redacted | c |
| Protocol (for publication) | D1_Sub-protocol 2025-521098-14-00 GZP2_Redacted | b |
| Protocol (for publication) | D4_Patient Documents Copyright | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure template | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_Tracked Changes | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_Recruitment and Informed consent procedure | 1.1 |
| Recruitment arrangements (for publication) | K1-Recruitment arrangement | 1 |
| Recruitment arrangements (for publication) | K1-Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Patient recruitment material generic_GZP1 | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material_Patient recruitment material generic_GZPO | 1 |
| Recruitment arrangements (for publication) | K2_Patient facing documents_Diet and Physical Activity Log | 1 |
| Recruitment arrangements (for publication) | K2_Patient recruitment material generic_GZP2 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitement material Clinlife Portal Patient Information | 1.0 |
| Recruitment arrangements (for publication) | K2_recruitment material_ list of appreciation items | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ClinLife Patient Recruitment | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EC Document_Recruitment_Master_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EC Document_Recruitment_Master_DE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_GZP1 Brochure_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_GZP1 Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_GZP1 Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_GZP2 Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_GZP2 Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of planned sites_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_GZPT_Letter-Doctor-Referral_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recrutiment Material_GZP2 Brochure_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recrutiment Material_GZP2 HbA1c Brochure_Master | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional Activity | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_main ICF_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Activity Addendum | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Activity Addendum_Tracked changes | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GI-AE-Brochure Master | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZP1_Flyer Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZP1_Hypo-Awareness Brochure Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZP1_Letter Doctor Referral Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZP1_Study-Guide Master_CZ_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZP2_Flyer_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZP2_Hypo-Awareness-Brochure_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZP2_Letter Doctor Referral Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZP2_Study-Guide Master_CZ_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Clinical Trial Ancillary Supply List_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Patient facing documents_Atom5 eCOA Platform Participant Quick Reference Guide_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Patient facing documents_Diet and Physical Activity Log_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Patient cards | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject material_Appreciation Items | 1 |
| Synopsis of the protocol (for publication) | D1_GZP1 Protocol Synopsis_ENG_2025-521098-14-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_GZP2 Protocol Synopsis_ENG_2025-521098-14-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_GZPO Protocol Synopsis_ENG_2025-521098-14-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GZP1_CZ_2025-521098-14-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GZP2_CZ_2025-521098-14-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GZPO_CZ_2025-521098-14-00_Redacted | c |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-16 | Germany | Acceptable 2025-07-10
|
2025-07-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-24 | Germany | Acceptable 2025-07-10
|
2025-07-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-06 | Germany | Acceptable 2025-07-10
|
2025-08-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-06 | Germany | Acceptable | 2025-08-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-13 | Germany | Acceptable 2026-01-21
|
2026-01-22 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-30 | Acceptable 2026-01-21
|
2026-01-30 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-16 | Germany | Acceptable 2026-04-16
|
2026-04-16 |