Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,000
Countries
3
Sites
32
Urinary Incontinence
To demonstrate orforglipron is superior to placebo in the change in weekly incontinence episode frequency.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Trial duration
- 12 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522514-23-00
- WHO UTN
- U1111-1324-4698
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
To demonstrate orforglipron is superior to placebo in the change in weekly incontinence episode frequency.
Conditions and MedDRA coding
Urinary Incontinence
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Have a body mass index that indicates obesity or overweight
- Have a diagnosis of stress urinary incontinence
Exclusion criteria 8
- Have given birth within one year of screening
- Have had urinary incontinence surgery or other types of surgeries
- Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence
- Have gained or lost more than 11 pounds within 90 days prior to screening
- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes
- Have had a heart condition within 90 days prior to screening
- Have used any weight loss medication or alternative remedies within 180 days prior to screening
- Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline in Incontinence Episode Frequency (IEF)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
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 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(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 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(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 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
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 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(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 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(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 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(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 16
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| The Hibbert Group ORL-000015926
|
Trenton, NJ, United States | Other |
| Zoom Health ORL-000015929
|
San Jose, CA, United States | Other |
| IQVIA Connected Devices ORL-000010815
|
Durham, United States | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Florence ORL-000012320
|
Atlanta, United States | Other |
| IQVIA Laboratories ORL-000012797
|
West Lothian, United Kingdom | Laboratory analysis |
| Lionbridge ORL-000015927
|
Waltham, MA, United States | Other |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Code 13 |
| Tier 1 Impact Pbc Inc. ORG-100050163
|
Covington, United States | Other |
| ICON Clinical Research ICON IDEA ORL-000015928
|
Blue Bell, PA, United States | Other |
| WCG Clinical Inc. ORL-000007439
|
Indianapolis, United States | Other |
| LedgerRun, Inc ClinRun ORL-000015925
|
Raleigh, United States | Other |
| Clinical Ink Inc. ORG-100042433
|
Winston Salem, United States | Data management |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
Locations
3 EU/EEA countries · 32 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 80 | 9 |
| Poland | Ongoing, recruiting | 80 | 6 |
| Romania | Ongoing, recruiting | 135 | 17 |
| Rest of world
India, Japan, Canada, Mexico, Korea, Republic of, China, United States
|
— | 705 | — |
Investigational sites
Gyncare MUDr. Michael Svec s.r.o.
Urolgynecology, Slovanska 2696/114, Vychodni Predmesti, Plzen 2-Slovany
NEUMED gynekologicka ambulance s.r.o.
Urolgynecology, Horni Namesti 1310/10a, 779 00, Olomouc
Gona spol. s r.o.
Urolgynecology, Narodni 961/25, Stare Mesto, Prague
GYNEKOLOGIE Sottner s.r.o.
Urolgynecology, Vystavni 9, Stare Brno, Brno-Stred
Kestr-gyn s.r.o.
Urolgynecology, Volovnice 437, 547 01, Nachod
GYNORD plus s.r.o.
Urolgynecology, Slavnikovcu 231/7, Marianske Hory, Ostrava
G CENTRUM Olomouc s.r.o.
Urolgynecology, Horni Namesti 285/8, 779 00, Olomouc
Urologie Benesov - Afimed
Urology, Konopišťská 1205/7, 256 01, Benešov
Agyno s.r.o.
Urolgynecology, Skolni 736/9, 360 17, Karlovy Vary
Ginemedica Research Sp. z o.o.
NA, Ul. Podwale 83/21, 50-414, Wroclaw
Euromedis Sp. z o.o.
NA, Ul. Powstancow Wielkopolskich 33 A, 70-111, Szczecin
Med Sp. z o.o.
NA, Ul. Polnej Rozy 6/u2, 02-798, Warsaw
In Vivo Sp. z o.o.
NA, Ul. Kaszubska 17h, 85-048, Bydgoszcz
Aidport Sp. z o.o.
NA, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
EMC Instytut Medyczny S.A.
NA, Ul. Pilczycka 144/148, 54-144, Wroclaw
Materna Care S.R.L.
Urology, Calea Aradului Nr 113, 300644, Timisoara
Spitalul Clinic Judetean De Urgenta Craiova
Urology, Strada Tabaci Nr 1, 200642, Craiova
Delta Health Care S.R.L.
Urology, Strada Caramfil G. Nicolae Nr 85a, 014142, Bucharest
Spitalul Clinic De Nefrologie Dr. Carol Davila
Urology, Calea Grivitei Nr 4, 010731, Bucharest
Gnosis Evomed S.R.L.
Urology, Strada Poet Cezar Bolliac 21b, 030911, Bucharest
Spitalul Clinic Colentina Bucuresti
Urology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Urology, Strada Vulcanescu Mircea 88, 010825, Bucharest
Spitalul Clinic Judetean De Urgenta Ilfov
Urology, Bulevardul Basarabia Nr 49-51, 022115, Bucharest
Institutul Clinic Fundeni
Urology, Soseaua Fundeni 258, 022328, Bucharest
Spitalul Clinic Judetean De Urgenta Bihor
Urology, Str Gheorghe Doja Nr 65, 410169, Oradea
Spitalul Clinic Judetean De Urgenta Brasov
Urology, Strada Oltet Nr. 2, 500152, Brasov
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Urology, Bulevardul Liviu Rebreanu 156, 300723, Timisoara
Clinica Polisano S.R.L.
Urology, Strada Constitutiei Nr 24, 550253, Sibiu
Centrul Medical Unirea S.R.L.
Urology, Strada Maniu Iuliu Nr 49, 500091, Brasov
Polaris Medical S.A.
Urology, Str. Principala Comuna Baciu 323t, 407062, Suceagu
Spitalul De Urgenta Al Ministerului Administratiei Si Internelor Prof.Dr.Dimitrie Gerota
Urology, Strada Vasile Vasilievici Stroescu 29-31 Sector 2, 021373, Bucharest
Spitalul Clinic Prof.Dr.Theodor Burghele
Urology III, Panduri Road 20, District 5, Bucharest
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 | 2026-02-13 | 2026-02-18 | |||
| Poland | 2026-02-12 | 2026-02-16 | |||
| Romania | 2026-02-13 | 2026-02-23 |
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_Protocol 2025-522514-23-00_redacted | a |
| Protocol (for publication) | D1_Protocol ISA1 2025-522514-23-00_redacted | initial |
| Protocol (for publication) | D1_Protocol ISA2 2025-522514-23-00_redacted | initial |
| Protocol (for publication) | D4_Patient Facing Documents_Copyright Template | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and consenting procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangement_Recruitment and IC procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_CZ | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K2_Doctor Referral Letter_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Doctor to Patient Letter_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Flyer_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_List of participating sites | 1 |
| Recruitment arrangements (for publication) | K2_List of sites_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GI-AE-Brochure_Master_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZPS_Brochure_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZPS_Flyer_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZPS_Letter Doctor to Patient_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZPS_Poster_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZPS_Visit-Card_Master_CZ_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HBP_Module-13-Worksheet_Master_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HBP_Participant-Nutrition-Hydration_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HBP_Site-Nutrition-Hydration_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Health-Journey-Support_Master_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-to-Patient_Master_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Obesity-Infographic_Master_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_SHOPPING-LIST_MASTER_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study-Connect-Participant_Master_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study-Guide_Master_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Supportive-Partner-Guide_Master_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Understanding-SUI_Master_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Study Brochure_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_GZPS_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_TC_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Confidentiality Company Information Notice | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card | 2 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | L3_Informed consent and patient recruitment procedure_PL | 1 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis _2025-522514-23-00_RO_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522514-23-00_RO_GZS1 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-522514-23-00_RO_GZS2 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GZPS_CZ_2025-522514-23-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GZPS_ENG_2025-522514-23-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GZS1_CZ_2025-522514-23-00_Clean | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GZS1_ENG_2025-522514-23-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GZS2_CZ_2025-522514-23-00_Clean | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_GZS2_ENG_2025-522514-23-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2025-522514-23-00_Redacted | a |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-22 | Poland | Acceptable 2026-01-23
|
2026-01-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-09 | Poland | Acceptable 2026-01-23
|
2026-02-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-13 | Poland | Acceptable | 2026-04-23 |