Clinical trial • Phase III • Other
ORFORGLIPRON HEMICALCIUM for Stress urinary incontinence | Urinary incontinence
Phase III trial of ORFORGLIPRON HEMICALCIUM for Stress urinary incontinence | Urinary incontinence.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Stress urinary incontinence | Urinary incontinence
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-09-2025
- First CTIS Authorization Date
- 26-01-2026
Trial design
Randomised, orforglipron tablet once daily (dose not specified); placebo to match ly (matching placebo), once daily-controlled Phase III trial across 32 sites in Czechia, Romania, Poland.
- Randomised
- Yes
- Comparator
- Orforglipron tablet once daily (dose not specified); Placebo to match ly (matching placebo), once daily
- Target Sample Size
- 705
Eligibility
Recruits 705 No vulnerable population selected; participants are adult female subjects. Informed consent is required (see subject information and informed consent form documents)..
- Pregnancy Exclusion
- Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study
- Vulnerable Population
- No vulnerable population selected; participants are adult female subjects. Informed consent is required (see subject information and informed consent form documents).
Inclusion criteria
- {"criterion_text":"- Have a body mass index that indicates obesity or overweight\n- Have a diagnosis of stress urinary incontinence"}
Exclusion criteria
- {"criterion_text":"- Have given birth within one year of screening\n- Have had urinary incontinence surgery or other types of surgeries\n- Have recently received onabotulinumtoxin A (Botox) bladder injections or currently taking medications for urinary incontinence\n- Have gained or lost more than 11 pounds within 90 days prior to screening\n- Have type 1 diabetes, type 2 diabetes, or any other type of diabetes\n- Have had a heart condition within 90 days prior to screening\n- Have used any weight loss medication or alternative remedies within 180 days prior to screening\n- Are pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed for the duration of the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from Baseline in Incontinence Episode Frequency (IEF)","definition_or_measurement_approach":"Change from baseline in weekly incontinence episode frequency (IEF)"}
Recruitment
- Digital Remote Recruitment
- True, televisit vendor (Zoom Health) for remote visits; digitalisation and eCOA/ePRO/digital workflow support from Florence, Veeva Systems Inc., Clinical Ink, IQVIA Connected Devices and IQVIA Connected services as listed in third-party vendor roles
- Planned Sample Size
- 705
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent obtained from each participant via Main ICF / SIS and ICF documents (L1_Main ICF_Redacted, L1_SIS and ICF_Main ICF_Redacted and language-specific ICFs). Participants are adult female subjects; no assent process for minors is indicated. ICFs/study information available in country-language versions (documents listed include Polish and Czech language ICFs and English translations).
Methods
- Posters (K2_Recruitment material_Poster / K2_Recruitment material_Poster_Master files listed)
- Flyers (K2_Recruitment material_Flyer_Master and K2_Recruitment material_GZPS_Flyer_Master files listed)
- Brochures / Study brochures (K2_Recruitment material_Brochure_Master, K2_Recruitment material_GZPS_Brochure_Master)
- Doctor-to-patient letters and doctor referral letters (K2_Doctor to Patient Letter, K2_Doctor Referral Letter, K2_Recruitment material_Letter-Doctor-to-Patient_Master)
- Patient information cards and study participant contact cards (K2_Recruitment material_Study-Connect-Participant, L2_Study Participant Contact Card, Patient Information Card)
- Visit cards and brochures given at sites (K2_Recruitment material_GZPS_Visit-Card_Master)
- Site-based recruitment and referrals via participating clinics/hospitals (lists of participating sites provided)
- Digital/televisit approaches supported by a televisit vendor (Zoom Health) and digitalisation solutions (Florence, Veeva, Clinical Ink) as listed among third-party vendors
Geography
- Total Number Of Sites
- 32
- Total Number Of Participants
- 295
Czechia
- Earliest CTIS Part Ii Submission Date
- 10-12-2025
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 47
- Number Of Sites
- 9
- Number Of Participants
- 80
Sites
- Site Name
- Gona spol. s r.o.
- Department Name
- Urolgynecology
- Principal Investigator Name
- Lukáš Horčička
- Principal Investigator Email
- horcic.luk@volny.cz
- Contact Person Name
- Lukáš Horčička
- Contact Person Email
- horcic.luk@volny.cz
- Site Name
- NEUMED gynekologicka ambulance s.r.o.
- Department Name
- Urolgynecology
- Principal Investigator Name
- David Neubert
- Principal Investigator Email
- neumed@seznam.cz
- Contact Person Name
- David Neubert
- Contact Person Email
- neumed@seznam.cz
- Site Name
- GYNORD plus s.r.o.
- Department Name
- Urolgynecology
- Principal Investigator Name
- Martina Vortelová Baričáková
- Principal Investigator Email
- martina.vortelova@gynordplus.cz
- Contact Person Name
- Martina Vortelová Baričáková
- Contact Person Email
- martina.vortelova@gynordplus.cz
- Site Name
- GYNEKOLOGIE Sottner s.r.o.
- Department Name
- Urolgynecology
- Principal Investigator Name
- Oldrich Šottner
- Principal Investigator Email
- sottner@gmail.com
- Contact Person Name
- Oldrich Šottner
- Contact Person Email
- sottner@gmail.com
- Site Name
- G CENTRUM Olomouc s.r.o.
- Department Name
- Urolgynecology
- Principal Investigator Name
- Aleš Skřivánek
- Principal Investigator Email
- skrivanek@g-centrum.cz
- Contact Person Name
- Aleš Skřivánek
- Contact Person Email
- skrivanek@g-centrum.cz
- Site Name
- Kestr-gyn s.r.o.
- Department Name
- Urolgynecology
- Principal Investigator Name
- Jan Kestřánek
- Principal Investigator Email
- kestra@volny.cz
- Contact Person Name
- Jan Kestřánek
- Contact Person Email
- kestra@volny.cz
- Site Name
- Gyncare MUDr. Michael Svec s.r.o.
- Department Name
- Urolgynecology
- Principal Investigator Name
- Michael Švec
- Principal Investigator Email
- michaelsvec@seznam.cz
- Contact Person Name
- Michael Švec
- Contact Person Email
- michaelsvec@seznam.cz
- Site Name
- Urologie Benesov - Afimed
- Department Name
- Urology
- Principal Investigator Name
- Aleš Fiala
- Principal Investigator Email
- ales.fiala@urologiebn.cz
- Contact Person Name
- Aleš Fiala
- Contact Person Email
- ales.fiala@urologiebn.cz
- Site Name
- Agyno s.r.o.
- Department Name
- Urolgynecology
- Principal Investigator Name
- Vladimír Kališ
- Principal Investigator Email
- vladimirkalis27@gmail.com
- Contact Person Name
- Vladimír Kališ
- Contact Person Email
- vladimirkalis27@gmail.com
Romania
- Earliest CTIS Part Ii Submission Date
- 06-10-2025
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 114
- Number Of Sites
- 17
- Number Of Participants
- 135
Sites
- Site Name
- Spitalul De Urgenta Al Ministerului Administratiei Si Internelor Prof.Dr.Dimitrie Gerota
- Department Name
- Urology
- Principal Investigator Name
- Catalin Belinski
- Principal Investigator Email
- drbelinski@yahoo.com
- Contact Person Name
- Catalin Belinski
- Contact Person Email
- drbelinski@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Ilfov
- Department Name
- Urology
- Principal Investigator Name
- Alexandru Mihalache
- Principal Investigator Email
- realmih@yahoo.com
- Contact Person Name
- Alexandru Mihalache
- Contact Person Email
- realmih@yahoo.com
- Site Name
- Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
- Department Name
- Urology
- Principal Investigator Name
- Victor Madan
- Principal Investigator Email
- victmad@gmail.com
- Contact Person Name
- Victor Madan
- Contact Person Email
- victmad@gmail.com
- Site Name
- Clinica Polisano S.R.L.
- Department Name
- Urology
- Principal Investigator Name
- Valentin Pirvut
- Principal Investigator Email
- pirvut_vali@yahoo.com
- Contact Person Name
- Valentin Pirvut
- Contact Person Email
- pirvut_vali@yahoo.com
- Site Name
- Gnosis Evomed S.R.L.
- Department Name
- Urology
- Principal Investigator Name
- Andrei Manu Marin
- Principal Investigator Email
- andrei.manumarin@yahoo.com
- Contact Person Name
- Andrei Manu Marin
- Contact Person Email
- andrei.manumarin@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Craiova
- Department Name
- Urology
- Principal Investigator Name
- Petru Octavian Dragoescu
- Principal Investigator Email
- pdragoescu@yahoo.com
- Contact Person Name
- Petru Octavian Dragoescu
- Contact Person Email
- pdragoescu@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Bihor
- Department Name
- Urology
- Principal Investigator Name
- Mihail Berechet
- Principal Investigator Email
- berechet.mihail@yahoo.com
- Contact Person Name
- Mihail Berechet
- Contact Person Email
- berechet.mihail@yahoo.com
- Site Name
- Spitalul Clinic De Nefrologie Dr. Carol Davila
- Department Name
- Urology
- Principal Investigator Name
- Mihai Dumitrache
- Principal Investigator Email
- mihai.dumitrache@yahoo.com
- Contact Person Name
- Mihai Dumitrache
- Contact Person Email
- mihai.dumitrache@yahoo.com
- Site Name
- Polaris Medical S.A.
- Department Name
- Urology
- Principal Investigator Name
- Nicolae Crisan
- Principal Investigator Email
- drnicolaecrisan@gmail.com
- Contact Person Name
- Nicolae Crisan
- Contact Person Email
- drnicolaecrisan@gmail.com
- Site Name
- Institutul Clinic Fundeni
- Department Name
- Urology
- Principal Investigator Name
- Robert Stoica
- Principal Investigator Email
- stoicarobert@gmail.com
- Contact Person Name
- Robert Stoica
- Contact Person Email
- stoicarobert@gmail.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
- Department Name
- Urology
- Principal Investigator Name
- Razvan Bardan
- Principal Investigator Email
- razvan.bardan@gmail.com
- Contact Person Name
- Razvan Bardan
- Contact Person Email
- razvan.bardan@gmail.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Brasov
- Department Name
- Urology
- Principal Investigator Name
- Ioan Scarneciu
- Principal Investigator Email
- urologie_scarneciu@yahoo.com
- Contact Person Name
- Ioan Scarneciu
- Contact Person Email
- urologie_scarneciu@yahoo.com
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Urology
- Principal Investigator Name
- Mihail Dragutescu
- Principal Investigator Email
- dmdcare2013@gmail.com
- Contact Person Name
- Mihail Dragutescu
- Contact Person Email
- dmdcare2013@gmail.com
- Site Name
- Materna Care S.R.L.
- Department Name
- Urology
- Principal Investigator Name
- Cristian Condoiu
- Principal Investigator Email
- cristian.condoiu@reginamaria.ro
- Contact Person Name
- Cristian Condoiu
- Contact Person Email
- cristian.condoiu@reginamaria.ro
- Site Name
- Delta Health Care S.R.L.
- Department Name
- Urology
- Principal Investigator Name
- Dragos Georgescu
- Principal Investigator Email
- dgeorgescu2000@yahoo.com
- Contact Person Name
- Dragos Georgescu
- Contact Person Email
- dgeorgescu2000@yahoo.com
- Site Name
- Spitalul Clinic Prof.Dr.Theodor Burghele
- Department Name
- Urology III
- Principal Investigator Name
- Viorel Jinga
- Principal Investigator Email
- vioreljinga@yahoo.com
- Contact Person Name
- Viorel Jinga
- Contact Person Email
- vioreljinga@yahoo.com
- Site Name
- Centrul Medical Unirea S.R.L.
- Department Name
- Urology
- Principal Investigator Name
- Marius Neculoiu
- Principal Investigator Email
- mneculoiu@yahoo.com
- Contact Person Name
- Marius Neculoiu
- Contact Person Email
- mneculoiu@yahoo.com
Poland
- Earliest CTIS Part Ii Submission Date
- 16-12-2025
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 128
- Number Of Sites
- 6
- Number Of Participants
- 80
Sites
- Site Name
- Aidport Sp. z o.o.
- Principal Investigator Name
- Krzysztof Szymanowski
- Principal Investigator Email
- kp.szymanowski@wp.pl
- Contact Person Name
- Krzysztof Szymanowski
- Contact Person Email
- kp.szymanowski@wp.pl
- Site Name
- Med Sp. z o.o.
- Principal Investigator Name
- Piotr Radziszewski
- Principal Investigator Email
- pradziszewski@medicalconcierge.pl
- Contact Person Name
- Piotr Radziszewski
- Contact Person Email
- pradziszewski@medicalconcierge.pl
- Site Name
- Euromedis Sp. z o.o.
- Principal Investigator Name
- Michal Soczawa
- Principal Investigator Email
- michal.soczawa@gmail.com
- Contact Person Name
- Michal Soczawa
- Contact Person Email
- michal.soczawa@gmail.com
- Site Name
- Ginemedica Research Sp. z o.o.
- Principal Investigator Name
- Anna Szwabowicz
- Principal Investigator Email
- a.szwabowicz@ginemedica.pl
- Contact Person Name
- Anna Szwabowicz
- Contact Person Email
- a.szwabowicz@ginemedica.pl
- Site Name
- In Vivo Sp. z o.o.
- Principal Investigator Name
- Piotr Piasecki
- Principal Investigator Email
- piotr.piasecki@in-vivo.pl
- Contact Person Name
- Piotr Piasecki
- Contact Person Email
- piotr.piasecki@in-vivo.pl
- Site Name
- EMC Instytut Medyczny S.A.
- Principal Investigator Name
- Rafal Kmieciak
- Principal Investigator Email
- rafal.kmieciak@emc-sa.pl
- Contact Person Name
- Rafal Kmieciak
- Contact Person Email
- rafal.kmieciak@emc-sa.pl
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Name
- ICON Clinical Research ICON IDEA
- Responsibilities
- medical expertise
- Name
- WCG Clinical Inc.
- Responsibilities
- Study Development/Conduct – Study Training
- Name
- IQVIA Laboratories
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"The Hibbert Group","duties_or_roles":"Shipping of R&R & Appreciation Items","organisation_type":"Health care"}
- {"country":"United States","full_name":"Zoom Health","duties_or_roles":"televisit vendor","organisation_type":"Health care"}
- {"country":"United States","full_name":"IQVIA Connected Devices","duties_or_roles":"","organisation_type":"Health care"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement and travel services","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Florence","duties_or_roles":"Digitalization solution to manage workflows","organisation_type":"Health care"}
- {"country":"United States","full_name":"IQVIA Laboratories","duties_or_roles":"","organisation_type":"Health care"}
- {"country":"United States","full_name":"Lionbridge","duties_or_roles":"Translation of R&R","organisation_type":"Health care"}
- {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Tier 1 Impact Pbc Inc.","duties_or_roles":"Study Development/Conduct – Study Training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"ICON Clinical Research ICON IDEA","duties_or_roles":"medical expertise","organisation_type":"Health care"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Study Development/Conduct – Study Training","organisation_type":"Industry"}
- {"country":"United States","full_name":"LedgerRun, Inc ClinRun","duties_or_roles":"Investgator Grants Payments System","organisation_type":"Health care"}
- {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Linguistically Validated Translations","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Laboratories (UK entry)","duties_or_roles":"","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- Orforglipron
- Active Substance
- ORFORGLIPRON HEMICALCIUM
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- oral
- Authorisation Status
- Not authorised
- Frequency
- once daily
- Investigational Product Name
- Placebo to match ly
- Modality
- Other
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