Clinical trial • Phase II • Other

VIPOGLANSTAT (GS-248) for Endometriosis

Phase II trial of VIPOGLANSTAT (GS-248) for Endometriosis.

Overview

Trial Therapeutic Area
Other
Trial Disease
Endometriosis
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
31-07-2025
First CTIS Authorization Date
21-11-2025

Trial design

Randomised, placebo: 'the placebo formulation for gs-248 is formulated in a capsule without the active ingredient. both vipoglanstat capsules and placebo are identical capsules.' active intervention: vipoglanstat (gs-248) given as two dose arms (two doses investigated) — specific dose levels and schedule not stated in provided material.-controlled Phase II trial across 42 sites in Bulgaria, Hungary, Czechia and others.

Randomised
Yes
Comparator
Placebo: 'The placebo formulation for GS-248 is formulated in a capsule without the active ingredient. Both vipoglanstat capsules and placebo are identical capsules.' Active intervention: Vipoglanstat (GS-248) given as two dose arms (two doses investigated) — specific dose levels and schedule not stated in provided material.
Target Sample Size
271

Eligibility

Recruits 271 No vulnerable populations selected (isVulnerablePopulationSelected:false). Participants are adults (premenopausal females 18 to <45). Subject information and informed consent forms are provided (multiple country-specific ICF documents listed, including pregnancy-specific ICFs). Consent is provided by the adult participant..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected:false). Participants are adults (premenopausal females 18 to <45). Subject information and informed consent forms are provided (multiple country-specific ICF documents listed, including pregnancy-specific ICFs). Consent is provided by the adult participant.

Inclusion criteria

  • {"criterion_text":"- 1.\tPremenopausal females 18 to <45 years of age at the time of Visit 1."}
  • {"criterion_text":"- 2.\tEndometriosis diagnosis confirmed and documented within the last 10 years prior to Visit 1 or during Visit 1 based on: 2a.\tSurgical (via direct visualization or biopsy verified) or 2b.\tImaging (ie, endometriotic lesion(s) detected by transvaginal sonography or magnetic resonance imaging [MRI])."}
  • {"criterion_text":"- 3.\tHistory of NMPP significantly affecting daily life confirmed at Visit 1."}
  • {"criterion_text":"- 4.\tThe participant reports moderate, severe, or very severe pain during non-menstrual days in the month prior to Visit 2, based on PGA-NMPP."}

Exclusion criteria

  • {"criterion_text":"- 1. Chronic pelvic pain that is not judged to be primarily related to endometriosis (eg, chronic pelvic infection, interstitial cystitis, nerve entrapments or neuropathies, non-endometriosis-related pelvic adhesive disease, persistent symptomatic ovarian cyst [eg, dermoid], posttubal ligation, symptomatic hydrosalpinx, and vaginismus)."}
  • {"criterion_text":"- 2. Has had more than 2 surgical procedures for endometriosis"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Proportion of participants with at least 2.0 points, or at least 30%, reduction of mean worst NMPP NRS score, without increase in opioid rescue medication use, during non-menstrual days, from baseline to the fourth month of treatment.","definition_or_measurement_approach":"Proportion of participants achieving ≥2.0 points or ≥30% reduction in mean worst non-menstrual pelvic pain (NMPP) Numeric Rating Scale (NRS) score from baseline to month 4, without an increase in opioid rescue medication use, measured during non-menstrual days."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change in mean worst NMPP NRS score from baseline to the fourth month of treatment","definition_or_measurement_approach":"Change from baseline to month 4 in mean worst NMPP NRS score."}
  • {"endpoint_text":"- 2. Proportion of participants with at least 2.0 points, or at least 30%, reduction of mean worst DYS NRS score, without increase in rescue medication use, during menstrual bleeding days, from baseline to the fourth month of treatment.","definition_or_measurement_approach":"Proportion achieving ≥2.0 points or ≥30% reduction in mean worst dysmenorrhea (DYS) NRS score from baseline to month 4 during menstrual bleeding days, without increase in rescue medication use."}
  • {"endpoint_text":"- 3. Change in mean worst DYS NRS score from baseline to the fourth month of treatment","definition_or_measurement_approach":"Change from baseline to month 4 in mean worst DYS NRS score."}
  • {"endpoint_text":"- 4. Change in EHP-30 score from Visit 3 to Visit 7.","definition_or_measurement_approach":"Change in Endometriosis Health Profile-30 (EHP-30) score between Visit 3 and Visit 7."}
  • {"endpoint_text":"- 5. Change in EHP-30 sexual intercourse subscale score from Visit 3 to Visit 7.","definition_or_measurement_approach":"Change in EHP-30 sexual intercourse subscale score between Visit 3 and Visit 7."}
  • {"endpoint_text":"- 6. Change in mean daily opioid rescue medication use for NMPP from baseline to the fourth month of treatment.","definition_or_measurement_approach":"Change from baseline to month 4 in mean daily opioid rescue medication use for NMPP."}
  • {"endpoint_text":"- 7. Change in mean daily opioid rescue medication use for DYS from baseline to the fourth month of treatment.","definition_or_measurement_approach":"Change from baseline to month 4 in mean daily opioid rescue medication use for DYS."}
  • {"endpoint_text":"- 8. AEs.","definition_or_measurement_approach":"Adverse events monitoring (safety endpoint)."}
  • {"endpoint_text":"- 9. Safety laboratory variables (clinical chemistry, hematology, and urinalysis).","definition_or_measurement_approach":"Clinical laboratory safety assessments including clinical chemistry, hematology, and urinalysis."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
271
Recruitment Window Months
19
Consent Approach
Informed consent provided by adult participants (all subjects are adults: premenopausal females 18 to <45). Country-specific subject information and informed consent forms are listed for Bulgaria, Hungary, Czechia, Poland, Romania, and Italy (multiple L1/L2 ICF documents). Pregnancy-specific ICFs/forms are available per country (pregnancy participant / pregnant partner forms). No assent process is indicated.

Methods

  • Country-specific recruitment materials documented: Patient brochures (K2_*_Brochure) for Bulgaria, Hungary, Czechia, Poland, Romania, Italy.
  • Patient letters (K2_*_Patient Letter) for multiple countries.
  • HCP letters (K2_HU_Recruitment Material_HCP Letter_Hungarian) to healthcare professionals (Hungary).
  • Advocacy factsheets (K2_*_Advocacy Factsheet/Advocacy Factbook) — country-specific advocacy materials.
  • Recruitment procedures documents (K1_*_Recruitment Procedure) for Bulgaria, Czechia, Poland, Romania, Italy indicate formal procedures.
  • Scout email communications and Scout brochures (Czech materials) indicating use of email outreach (Scout Clinical).

Geography

Total Number Of Sites
42
Total Number Of Participants
271

Bulgaria

Earliest CTIS Part Ii Submission Date
07-11-2025
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
18
Number Of Sites
3
Number Of Participants
34

Sites

Site Name
Medical Center Femiclinic EOOD
Principal Investigator Name
Ivan Kostov
Principal Investigator Email
prof.ivankostovfc@gmail.com
Contact Person Name
Ivan Kostov
Contact Person Email
prof.ivankostovfc@gmail.com
Site Name
Mbal Lyulin EAD
Department Name
Department of Gynecology
Principal Investigator Name
Teodor Dakov
Principal Investigator Email
dr_dakov@mail.bg
Contact Person Name
Teodor Dakov
Contact Person Email
dr_dakov@mail.bg
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
Department of Obstetrics and Gynecology
Principal Investigator Name
Lyubomir Malchev
Principal Investigator Email
l.malchev@mbalpuls.bg
Contact Person Name
Lyubomir Malchev
Contact Person Email
l.malchev@mbalpuls.bg

Hungary

Earliest CTIS Part Ii Submission Date
26-09-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
59
Number Of Sites
5
Number Of Participants
64

Sites

Site Name
MedEnd Kft.
Principal Investigator Name
Attila BOKOR
Principal Investigator Email
attila.z.bokor@gmail.com
Contact Person Name
Attila BOKOR
Contact Person Email
attila.z.bokor@gmail.com
Site Name
Semmelweis University
Department Name
Szülészeti és Nőgyógyászati Klinika
Principal Investigator Name
Nándor ÁCS
Principal Investigator Email
acs.nandor@med.semmelweis.hu
Contact Person Name
Nándor ÁCS
Contact Person Email
acs.nandor@med.semmelweis.hu
Site Name
TritonLife Magankorhazak Zrt.
Principal Investigator Name
Árpád RUCZ
Principal Investigator Email
rucz1@hotmail.com
Contact Person Name
Árpád RUCZ
Contact Person Email
rucz1@hotmail.com
Site Name
University Of Debrecen
Department Name
Szülészeti és Nőgyógyászati Klinika
Principal Investigator Name
Rudolf LAMPÉ
Principal Investigator Email
lampe.rudolf@med.unideb.hu
Contact Person Name
Rudolf LAMPÉ
Contact Person Email
lampe.rudolf@med.unideb.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Szülészet – Nőgyógyászati Osztály
Principal Investigator Name
István PÉTERFI
Principal Investigator Email
istvan.peterfi@gmail.com
Contact Person Name
István PÉTERFI
Contact Person Email
istvan.peterfi@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
73
Number Of Sites
8
Number Of Participants
17

Sites

Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Gynekologicko-porodnická klinika
Principal Investigator Name
Michael Halaška
Principal Investigator Email
michael.halaska@fnkv.cz
Contact Person Name
Michael Halaška
Contact Person Email
michael.halaska@fnkv.cz
Site Name
NEUMED gynekologicka ambulance s.r.o.
Principal Investigator Name
David Neubert
Principal Investigator Email
neumed@seznam.cz
Contact Person Name
David Neubert
Contact Person Email
neumed@seznam.cz
Site Name
Fakultni Nemocnice Bulovka
Department Name
Gynekologicko-porodnická klinika
Principal Investigator Name
Peter Koliba
Principal Investigator Email
peter.koliba@bulovka.cz
Contact Person Name
Peter Koliba
Contact Person Email
peter.koliba@bulovka.cz
Site Name
Stella-Gyn s.r.o.
Principal Investigator Name
Pavlína Šafránková
Principal Investigator Email
gynekologievodnany@seznam.cz
Contact Person Name
Pavlína Šafránková
Contact Person Email
gynekologievodnany@seznam.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Gynekologicko-porodnická klinika FN Brno
Principal Investigator Name
Robert Hudeček
Principal Investigator Email
hudecek.robert@fnbrno.cz
Contact Person Name
Robert Hudeček
Contact Person Email
hudecek.robert@fnbrno.cz
Site Name
Gyncare MUDr. Michael Svec s.r.o.
Principal Investigator Name
Michael Švec
Principal Investigator Email
michaelsvec@seznam.cz
Contact Person Name
Michael Švec
Contact Person Email
michaelsvec@seznam.cz
Site Name
Gynekologie MEDA s.r.o.
Principal Investigator Name
Leopold Rotter
Principal Investigator Email
rotter@gynmeda.cz
Contact Person Name
Leopold Rotter
Contact Person Email
rotter@gynmeda.cz
Site Name
Fakultni Nemocnice Brno (additional listed site)
Principal Investigator Name
Robert Hudeček
Principal Investigator Email
hudecek.robert@fnbrno.cz
Contact Person Name
Robert Hudeček
Contact Person Email
hudecek.robert@fnbrno.cz

Poland

Earliest CTIS Part Ii Submission Date
05-11-2025
Latest Decision Or Authorization Date
24-11-2025
Processing Time Days
19
Number Of Sites
14
Number Of Participants
68

Sites

Site Name
Centrum Medyczne Justmed Sp. z o.o.
Department Name
ETG JustMed
Principal Investigator Name
Wojciech Majkusiak
Principal Investigator Email
j.klimkiewicz@etg-network.com
Contact Person Name
Wojciech Majkusiak
Contact Person Email
j.klimkiewicz@etg-network.com
Site Name
Centrum Ginekologii Endokrynologii I Medycyny Rozrodu Artemida Domitrz I Partnerzy Sp. p. Lekarzy
Principal Investigator Name
Jacek Szamatowicz
Principal Investigator Email
kontakt@artemida-online.pl
Contact Person Name
Jacek Szamatowicz
Contact Person Email
kontakt@artemida-online.pl
Site Name
Lukmed 2 Sp. z o.o.
Department Name
ETG Siedlce
Principal Investigator Name
Małgorzata Komsta-Goś
Principal Investigator Email
m.komstagos@etg-network.com
Contact Person Name
Małgorzata Komsta-Goś
Contact Person Email
m.komstagos@etg-network.com
Site Name
Grażyna Bogutyn Medico Praktyka Lekarska
Principal Investigator Name
Grażyna Bogutyn
Principal Investigator Email
gbogutyn@post.pl
Contact Person Name
Grażyna Bogutyn
Contact Person Email
gbogutyn@post.pl
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Medem Wilk Sp. j.
Department Name
NZOZ Medem
Principal Investigator Name
Krzysztof Wilk
Principal Investigator Email
Krzysztof.wilk@onet.pl
Contact Person Name
Krzysztof Wilk
Contact Person Email
Krzysztof.wilk@onet.pl
Site Name
Provita Sp. z o.o.
Department Name
Centrum Medyczne Angelius
Principal Investigator Name
Mariusz Kiecka
Principal Investigator Email
m.kiecka@angelius.org
Contact Person Name
Mariusz Kiecka
Contact Person Email
m.kiecka@angelius.org
Site Name
Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski sp.k.
Principal Investigator Name
Janusz Tomaszewski
Principal Investigator Email
klinika.jtomaszewski@wp.pl
Contact Person Name
Janusz Tomaszewski
Contact Person Email
klinika.jtomaszewski@wp.pl
Site Name
Hlk Sp. z o.o.
Department Name
Centrum Medyczne Chodźki
Principal Investigator Name
Maciej Paszkowski
Principal Investigator Email
mapaszko@tlen.pl
Contact Person Name
Maciej Paszkowski
Contact Person Email
mapaszko@tlen.pl
Site Name
Specjalistyczna Praktyka Lekarska Krzysztof Dynowski
Principal Investigator Name
Krzysztof Dynowski
Principal Investigator Email
krzysztof.dynowski@interia.pl
Contact Person Name
Krzysztof Dynowski
Contact Person Email
krzysztof.dynowski@interia.pl
Site Name
Provita Sp. z o.o. (Fabryczna 15b)
Department Name
Centrum Medyczne Angelius
Principal Investigator Name
Mariusz Kiecka
Principal Investigator Email
m.kiecka@angelius.org
Contact Person Name
Mariusz Kiecka
Contact Person Email
m.kiecka@angelius.org
Site Name
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Katarzyna Oronowicz
Principal Investigator Email
oronowicz@twojaprzychodnia.com
Contact Person Name
Katarzyna Oronowicz
Contact Person Email
oronowicz@twojaprzychodnia.com
Site Name
In Vivo Sp. z o.o.
Department Name
IN-VIVO BYDGOSZCZ
Principal Investigator Name
Marek Szymański
Principal Investigator Email
m.szymanski@in-vivo.pl
Contact Person Name
Marek Szymański
Contact Person Email
m.szymanski@in-vivo.pl
Site Name
Aidport Sp. z o.o.
Principal Investigator Name
Krzysztof Szymanowski
Principal Investigator Email
rejestracja@aidport.pl
Contact Person Name
Krzysztof Szymanowski
Contact Person Email
rejestracja@aidport.pl
Site Name
Vita Longa Sp. z o.o.
Department Name
Niepubliczny Zakład Opieki Zdrowotnej Vita Longa Sp. z o.o.
Principal Investigator Name
Małgorzata Janik
Principal Investigator Email
biuro@researchsolutions.pl
Contact Person Name
Małgorzata Janik
Contact Person Email
biuro@researchsolutions.pl

Italy

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
21-11-2025
Processing Time Days
88
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Clinica ostetrica e ginecologica
Principal Investigator Name
Angelo Cagnacci
Principal Investigator Email
angelo.cagnacci@unige.it
Contact Person Name
Angelo Cagnacci
Contact Person Email
angelo.cagnacci@unige.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
U.O.C. di Ostetricia e Ginecologia
Principal Investigator Name
Antonio Maiorana
Principal Investigator Email
Antonio.maiorana@arnascivico.it
Contact Person Name
Antonio Maiorana
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Dipartimento di Scienze Biomediche Sperimentali e Cliniche
Principal Investigator Name
Silvia Vannuccini
Principal Investigator Email
silvia.vannuccini@unifi.it
Contact Person Name
Silvia Vannuccini
Contact Person Email
silvia.vannuccini@unifi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Scienze della salute della donna, del bambino e di sanità pubblica
Principal Investigator Name
Alessandra De Cicco Nardone
Contact Person Name
Alessandra De Cicco Nardone

Romania

Earliest CTIS Part Ii Submission Date
19-02-2026
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
25
Number Of Sites
8
Number Of Participants
58

Sites

Site Name
Delta Health Care S.R.L.
Department Name
Obstetrics-Gynecology
Principal Investigator Name
Erna Stoian
Principal Investigator Email
alis.mihai@reginamaria.com
Contact Person Name
Erna Stoian
Contact Person Email
alis.mihai@reginamaria.com
Site Name
Centrul Medical Unirea S.R.L.
Department Name
Obstetrics-Gynecology
Principal Investigator Name
Ioana Pavaleanu
Principal Investigator Email
Ioana_pavaleanu@yahoo.com
Contact Person Name
Ioana Pavaleanu
Contact Person Email
Ioana_pavaleanu@yahoo.com
Site Name
San Medica S.R.L.
Department Name
Obstetrics-Gynecology
Principal Investigator Name
Gheorghita Trusca
Principal Investigator Email
leonora.cocosila@clintrial.ro
Contact Person Name
Gheorghita Trusca
Contact Person Email
leonora.cocosila@clintrial.ro
Site Name
Centrul Medical Unirea S.R.L. (Brasov)
Principal Investigator Name
Marius Alexandru Moga
Principal Investigator Email
brasov@reginamaria.ro
Contact Person Name
Marius Alexandru Moga
Contact Person Email
brasov@reginamaria.ro
Site Name
Genesys Fertility Center S.R.L.
Department Name
Obstetrics-Gynecology
Principal Investigator Name
Aida Tincuta Petca
Principal Investigator Email
genesysfertilitycenter@yahoo.com
Contact Person Name
Aida Tincuta Petca
Site Name
Quantum Medical Center S.R.L.
Department Name
Obstetrics-Gynecology
Principal Investigator Name
Daniel Tutunaru
Principal Investigator Email
daniel.tutunaru@clinicaccbr.com
Contact Person Name
Daniel Tutunaru
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
Obstetrics-Gynecology
Principal Investigator Name
Lucian Puscasiu
Principal Investigator Email
secretariat@spitalmures.ro
Contact Person Name
Lucian Puscasiu
Contact Person Email
secretariat@spitalmures.ro
Site Name
Spitalul Clinic Filantropia
Department Name
Gynecology
Principal Investigator Name
Claudia Mehedintu
Principal Investigator Email
office@spitalulfilantropia.ro
Contact Person Name
Claudia Mehedintu
Contact Person Email
office@spitalulfilantropia.ro

Sponsor

Primary sponsor

Full Name
Gesynta Pharma AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple sponsor duties (codes listed in CTIS); includes MRI reading
Name
Almac Clinical Services Limited
Responsibilities
Clinical supplies management. IMP packaging, labelling and batch release
Name
Eresearchtechnology Inc.
Responsibilities
Sponsor duty code 7 (as listed in CTIS)

Third parties

  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Clinical supplies management. IMP packaging, labelling and batch release","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment","duties_or_roles":"Equipment supplies - freezers","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement and travel arrangements","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Multiple sponsor duties (codes provided in CTIS); includes 'MRI reading'","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Karolinska Institutet Biobank","duties_or_roles":"Biobank","organisation_type":"Industry"}
  • {"country":"Sweden","full_name":"Lablytica Life Science AB","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Vipoglanstat
Active Substance
VIPOGLANSTAT (GS-248)
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Investigational Product Name
GS-248 (alternate name for Vipoglanstat)
Active Substance
GS-248
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Investigational Product Name
The placebo formulation for GS-248 is formulated in a capsule without the active ingredient. Both vipoglanstat capsules and placebo are identical capsules.
Modality
Other

Related trials

Other published trials that may interest you.