Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,460
Countries
3
Sites
36
Overweight
To demonstrate that LY3502970 is superior to placebo in change from baseline for body weight.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 25 Sep 2023 → 8 Aug 2025
- Decision date (initial)
- 2023-09-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-502837-24-00
- WHO UTN
- U1111-1289-8799
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy, Pharmacokinetic, Pharmacodynamic, Dose response
To demonstrate that LY3502970 is superior to placebo in change from baseline for body weight.
Conditions and MedDRA coding
Overweight
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Be overweight or have excess weight.
- Have history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- Have type 2 diabetes and on stable treatment for Type 2 diabetes for at least 90 days prior to screening.
- Have been taking up to 3 oral anti-hyperglycemic medications
Exclusion criteria 6
- Have type 1 diabetes or any other type of diabetes except type 2
- Have a change in body weight more than 11 pounds within 90 days before screening.
- Have medullary thyroid cancer or multiple endocrine neoplasia type 2
- Have a history of chronic or acute pancreatitis
- Have diabetic retinopathy and/or macular edema requiring acute treatment.
- Have active or untreated cancer for less than 5 years.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mean Percent Change from Baseline in Body Weight (from Baseline to Week 72)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
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
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
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
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
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
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
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
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
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
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
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 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- 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
Sodium bicarbonate - 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.
- 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 10
| Organisation | City, country | Duties |
|---|---|---|
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | E-data capture |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10 |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| R&G US, Inc. ORL-000001478
|
Gaithersburg, MD, United States | Code 10 |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
Locations
3 EU/EEA countries · 36 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 175 | 12 |
| Germany | Ended | 140 | 17 |
| Greece | Ended | 75 | 7 |
| Rest of world
Australia, Argentina, Korea, Republic of, China, India, United States, Brazil
|
— | 1,070 | — |
Investigational sites
Diahelp s.r.o.
DIAHELP s.r.o., Pod Brizkami 897, Zelene Predmesti, Pardubice V
Diabet2 s.r.o.
Diabet2 s.r.o., Revolucni 765/19, Stare Mesto, Prague 1
Dialine s.r.o.
DIALINE s.r.o., Tylova 502/39, Jizni Predmesti, Plzen 3
Nemocnice Český Krumlov, a.s.
Nemocnice Český Krumlov, a.s., Nemocniční 429, 38101, Český Krumlov
MUDr. Sabina Pálová
MUDr. Sabina Pálová, Rudných dolů 291, 25242, Jílové u Prahy
Milan Kvapil s.r.o.
Milan Kvapil s.r.o., Lucni 1611, 263 01, Dobris
Endokrinologie MUDr. Řehořková s.r.o.
Endokrinologie MUDr. Řehořková s.r.o., třída Edvarda Beneše 1549/34, 50012, Hradec Králové
Milan Kvapil s.r.o.
Milan Kvapil s.r.o., Lucni 1611, 263 01, Dobris
ResTrial s.r.o.
ResTrial s.r.o., V Sadech 4a/1081, 160 00, Prague 6
MuDr. Jitka Zemanova Diabetologie A Interna s.r.o.
MUDr. Jitka Zemanova - diabetologie a interna s.r.o., Francouzska Trida 2080/4, Vychodni Predmesti, Plzen 2-Slovany
MUDr. Tomas Edelsberger
MUDr. Tomáš Edelsberger, Náměstí Minoritů 86/7, 79401, Krnov
MUDr. Alena Váchová
MUDr. Alena Váchová, České Vrbné 2403, 37011, České Budějovice
ceda-research
N/A, Neue Mitte 10, Haus 4, Pohlheim
BAG Diabeteszentrum Dr. Tews & Partner
N/A, Herzbachweg 14E, Haus E, Gelnhausen
Gemeinschaftspraxis Dr. med. Ralf Denger und Dr. med. Thomas Pfitzner
N/A, Zum Grühlingsstollen 3, Saarland, Friedrichsthal
AmBeNet GmbH
N/A, Wilhelm-Leuschner-Platz 12, Sachsen, Leipzig
SMO.MD GmbH
N/A, 9, Bierer Weg, Magdeburg
Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
N/A, An der Pforte 5, 06679, Hohenmölsen
Innodiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Medizentrum Essen Borbeck
N/A, Hülsmannstraße 6, Medizentrum Essen-Borbeck, Essen
Diabetes Zentrum Wilhelmsburg
N/A, Krieterstr. 30, Hamburg, Hamburg
Gemeinschaftspraxis Dr. med. Josef und Dr. med. Wilma Großkopf
N/A, Ahornstraße 2a, 94574, Wallerfing
Arztpraxis Christine Kosch Pirna
N/A, Königsteiner Strasse 6 b, Sachsen, Pirna
Universität zu Lübeck - Institut für Endokrinologie und Diabetes
N/A, Marie-Curie-Strasse, CBBM, Lübeck
Institut für Diabetesforschung GmbH Münster
N/A, Hohenzollernring 70, FranziskusCarree 3.OG, Münster
CDG Studienambulanz Hartard
N/A, Helene-Mayer-Ring 14, Bayern, München
Universitaetsklinikum Koeln
Endocrinology, Diabetes and Preventive Medicine, Kerpener Straße 62, Bettenhaus, Köln
RED-Institut GmbH
N/A, Markt 15, Schleswig-Holstein, Oldenburg
University Of Luebeck
N/A, Ratzeburger Allee 160, Strecknitz, Luebeck
Athens Medical Center S.A.
Department of Internal Medicine, Diabetes and Obesity Unit, Distomou 5-7, 151 25, Maroussi
General Hospital Of Thessaloniki Papageorgiou
1st Department of Internal Medicine, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
Euromedica General Clinic Of Thessaloniki
Endocrinology Diabetes & Metabolism Department, Kallas Marias 11, Gravias 2, Thessaloniki
General University Hospital Of Larissa
Clinic of Endocrinology and Metabolic Diseases, P. O. Box 1425, 411 10, Larissa
424 Military General Training Hospital
2nd Internal Medicine Clinic, Ring Road, N. Efkarpia, Thessaloniki
Ippokratio General Hospital Of Thessaloniki
Diabetes Center, 2nd Propaedeutic Internal Medicine Clinic, Konstadinoupoleos 49, 546 42, Thessaloniki
Thermi Clinic S.A.
Internal Medicine Department, 14th Kms N Moudanion, 570 01, Thessaloniki
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 | 2023-09-26 | 2025-08-05 | 2023-09-27 | 2024-02-14 | |
| Germany | 2023-09-25 | 2025-08-07 | 2023-09-28 | 2024-02-14 | |
| Greece | 2023-09-27 | 2025-07-28 | 2023-09-29 | 2024-02-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 26 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2022-502837-24-00_Redacted | d |
| Protocol (for publication) | D1_Protocol_2022-502837-24-00_GR_Redacted | d |
| Protocol (for publication) | GZGQ_Patient Documents Copyright | 1.0 |
| Recruitment arrangements (for publication) | 1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_GR_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_GR | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_GR_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_Main ICF_GR_track changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Pregnant Partner ICF_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other information_CONTACT-CARD_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other information_STUDY-GUIDE_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other information_THANK-YOU-END OF STUDY_GR | 3 |
| Subject information and informed consent form (for publication) | L2_Other information_THANK-YOU-PARTICIPATION_GR | 3 |
| Subject information and informed consent form (for publication) | L2_Other information_VISIT-CARD_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Ancillary Supplies List_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Appreciation items | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_NPA_HYPOGLYCAEMIA BROCHURE_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_NPA_REFERENCE CARD_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Information Card_GR | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis MS_CZ_2022-502837-24-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS_CZ_2022-502837-24-00_Tracked changes_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2022-502837-24-00_GR_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GER_2022-502837-24-00_Redacted | d |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_GER_2022-502837-24-00_TC_Redacted | d |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-26 | Germany | Acceptable 2023-09-18
|
2023-09-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-25 | Acceptable 2023-09-18
|
2023-09-25 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-29 | Germany | Acceptable 2024-01-30
|
2024-01-31 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-03-26 | Germany | Acceptable 2024-01-30
|
2024-03-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-05 | Germany | Acceptable | 2024-04-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-10 | Acceptable | 2024-06-10 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-10 | Acceptable | 2024-05-31 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-10 | Germany | Acceptable | 2025-07-10 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-10 | Germany | Acceptable | 2025-07-10 |
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-11 | Acceptable | 2025-08-12 |