Clinical trial • Phase III • Endocrinology|Gastroenterology

BIO89-100 for Metabolic dysfunction-associated steatohepatitis (MASH) with compensated cirrhosis

Phase III trial of BIO89-100 for Metabolic dysfunction-associated steatohepatitis (MASH) with compensated cirrhosis.

Overview

Trial Therapeutic Area
Endocrinology|Gastroenterology
Trial Disease
Metabolic dysfunction-associated steatohepatitis (MASH) with compensated cirrhosis
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
24-06-2024
First CTIS Authorization Date
04-10-2024

Trial design

Randomised, placebo for pegozafermin (combined integral administration device: pre-filled syringe). dose and schedule for placebo not specified in the provided record.-controlled, adaptive Phase III trial in Italy, Germany, Hungary and others.

Randomised
Yes
Comparator
Placebo for pegozafermin (combined integral administration device: pre-filled syringe). Dose and schedule for placebo not specified in the provided record.
Adaptive
True, includes a planned interim analysis (interim analysis to evaluate proportion achieving fibrosis regression at Month 24) and a final analysis for time-to-event composite clinical endpoint; no dose-escalation rules described in the provided materials.
Target Sample Size
607
Trial Duration For Participant
730

Eligibility

Recruits 607 Vulnerable population flag selected (isVulnerablePopulationSelected = true). Informed consent is required via an informed consent form (ICF); multiple subject information and informed consent documents are listed for different countries and languages (see L1_SIS and ICF documents). Participants are adults (18–75 years). No mention of assent procedures or inclusion of minors in the provided documentation..

Pregnancy Exclusion
1_Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF)
Vulnerable Population
Vulnerable population flag selected (isVulnerablePopulationSelected = true). Informed consent is required via an informed consent form (ICF); multiple subject information and informed consent documents are listed for different countries and languages (see L1_SIS and ICF documents). Participants are adults (18–75 years). No mention of assent procedures or inclusion of minors in the provided documentation.

Inclusion criteria

  • {"criterion_text":"- 1_Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF)\n- 2_Presence of type 2 diabetes mellitus (T2DM) diagnosed at least 3 months before Screening or at least two metabolic risk factors as defined in the protocol\n- 3_Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis [NASH] Clinical Research Network (CRN) system) with compensated cirrhosis\n- 4_Body mass index (BMI) at Screening ≥25.0 (≥23.0 for Asian subjects) and <50.0 kg/m2"}

Exclusion criteria

  • {"criterion_text":"- 1_Liver disorder other than MASH\n- 2_History or evidence of hepatic decompensation\n- 3_History or evidence of hepatocellular carcinoma\n- 4_Have type 1 diabetes mellitus or unstable type 2 diabetes mellitus\n- 5_ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L)\n- 6_Participants taking vitamin E (>400 international units [IU]/day) must be on stable dose for at least 6 months prior to screening and up to randomization"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1_At interim analysis: Proportion of subjects achieving fibrosis regression, defined as improvement in fibrosis by ≥1 stage, at Month 24 biopsy relative to baseline biopsy","definition_or_measurement_approach":"Fibrosis regression defined as improvement in fibrosis by ≥1 stage measured by comparison of Month 24 liver biopsy to baseline biopsy."}
  • {"endpoint_text":"- 2_At study completion: Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events","definition_or_measurement_approach":"Time-to-event for first occurrence of disease progression measured by a composite of protocol-specified clinical events (composite clinical endpoint)."}

Secondary endpoints

  • {"endpoint_text":"- 1_At interim analysis and study completion: Change from baseline in ELF score","definition_or_measurement_approach":"Change from baseline in ELF (Enhanced Liver Fibrosis) score measured at interim and completion."}
  • {"endpoint_text":"- 2_At interim analysis and study completion: Change from baseline in ALT","definition_or_measurement_approach":"Change from baseline in alanine aminotransferase (ALT) measured at interim and completion."}
  • {"endpoint_text":"- 3_At interim analysis and study completion: Change from baseline in FibroScan VCTE","definition_or_measurement_approach":"Change from baseline in vibration-controlled transient elastography (FibroScan VCTE) measured at interim and completion."}
  • {"endpoint_text":"- 4_At study completion: Proportion of subjects who develop CSPH","definition_or_measurement_approach":"Proportion developing clinically significant portal hypertension (CSPH) by study completion as defined in protocol."}
  • {"endpoint_text":"- 5_At study completion: Time to progression to large gastric or esophageal varices and/or varices with “red-wale” signs or endoscopic treatment of esophageal or gastric varices","definition_or_measurement_approach":"Time-to-event for progression to large varices and/or varices with red-wale signs or requirement for endoscopic treatment."}
  • {"endpoint_text":"- 6_At study completion: Time to clinically important ascites as determined by the onset of Grade ≥2 (clinically apparent) ascites leading to diagnostic paracentesis or initiation of specific treatment for ascites (e.g., diuretics, therapeutic paracentesis, or TIPS)","definition_or_measurement_approach":"Time-to-event to clinically important (Grade ≥2) ascites requiring paracentesis or specific ascites treatment."}
  • {"endpoint_text":"- 7_At study completion: Time to overt hepatic encephalopathy (altered mental status without alternate explanation requiring acute medical attention and either initiation of specific therapy or modification of existing treatment)","definition_or_measurement_approach":"Time-to-event to overt hepatic encephalopathy defined as altered mental status requiring acute medical attention and initiation/modification of therapy."}

Recruitment

Planned Sample Size
607
Recruitment Window Months
82
Consent Approach
Informed consent obtained via a written informed consent form (ICF). Multiple subject information and ICF documents are provided (L1_SIS and ICF) for different countries. ICFs and related participant materials are available in multiple languages (documents include English, French, Dutch, German, Hungarian, Italian, Polish, Spanish, Bulgarian versions). Consent is provided by the adult participant; no assent procedures for minors are indicated.

Geography

Total Number Of Sites
69
Total Number Of Participants
155

Italy

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
449
Number Of Sites
11
Number Of Participants
23

Sites

Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Gastroenterology, Hepatology and Transplant
Principal Investigator Name
Stefano Fagiuoli
Principal Investigator Email
sfagiuoli@asst-pg23.it
Contact Person Name
Stefano Fagiuoli
Contact Person Email
sfagiuoli@asst-pg23.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Hepatology and Gastroenterology
Principal Investigator Name
Monica Cucco
Principal Investigator Email
monica.cucco@ospedaleniguarda.it
Contact Person Name
Monica Cucco
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
Clinical Medicine and Hepatology
Principal Investigator Name
Umberto Vespasiani Gentilucci
Principal Investigator Email
u.vespasiani@policlinicocampus.it
Contact Person Name
Umberto Vespasiani Gentilucci
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Internal Medicine
Principal Investigator Name
Cristina Rigamonti
Principal Investigator Email
cristina.rigamonti@uniupo.it
Contact Person Name
Cristina Rigamonti
Contact Person Email
cristina.rigamonti@uniupo.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Internal Medicine and Gastroenterology
Principal Investigator Name
Antonio Gasbarrini
Principal Investigator Email
Antonio.Gasbarrini@unicatt.it
Contact Person Name
Antonio Gasbarrini
Contact Person Email
Antonio.Gasbarrini@unicatt.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
Hepatology
Principal Investigator Name
Gaetano Serviddio
Principal Investigator Email
trial.epatologia@unifg.it
Contact Person Name
Gaetano Serviddio
Contact Person Email
trial.epatologia@unifg.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Gastroenterology
Principal Investigator Name
Salvatore Petta
Principal Investigator Email
salvatore.petta@unipa.it
Contact Person Name
Salvatore Petta
Contact Person Email
salvatore.petta@unipa.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Pietro Lampertico
Principal Investigator Email
pietro.lampertico@unimi.it
Contact Person Name
Pietro Lampertico
Contact Person Email
pietro.lampertico@unimi.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Internal Medicine and Hepatology
Principal Investigator Name
Alessio Michele Goffredo Aghemo
Principal Investigator Email
alessio.aghemo@hunimed.eu
Contact Person Name
Alessio Michele Goffredo Aghemo
Contact Person Email
alessio.aghemo@hunimed.eu
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Gastroenterology
Principal Investigator Name
Elisabetta Bugianesi
Principal Investigator Email
elisabetta.bugianesi@unito.it
Contact Person Name
Elisabetta Bugianesi
Contact Person Email
elisabetta.bugianesi@unito.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita (duplicate entry?)
Department Name
Gastroenterology

Germany

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
451
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik 1
Principal Investigator Name
Anita Pathil-Warth
Principal Investigator Email
pathilwa@med.uni-frankfurt.de
Contact Person Name
Anita Pathil-Warth
Contact Person Email
pathilwa@med.uni-frankfurt.de
Site Name
Universitaet Muenster
Department Name
Medical Clinic B
Principal Investigator Name
Jonel Trebicka
Principal Investigator Email
jonel.trebicka@ukmuenster.de
Contact Person Name
Jonel Trebicka
Contact Person Email
jonel.trebicka@ukmuenster.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
Zentrum Innere Medizin II
Principal Investigator Name
Thaddäus Till Hippokrates Wissniowski
Principal Investigator Email
t.wissniowski@skc.de
Contact Person Name
Thaddäus Till Hippokrates Wissniowski
Contact Person Email
t.wissniowski@skc.de
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Jörn Schattenberg
Principal Investigator Email
joern.schattenberg@uks.eu
Contact Person Name
Jörn Schattenberg
Contact Person Email
joern.schattenberg@uks.eu
Site Name
Medizinische Hochschule Hannover
Department Name
Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
Principal Investigator Name
Heiner Wedemeyer
Principal Investigator Email
wedemeyer.heiner@mh-hannover.de
Contact Person Name
Heiner Wedemeyer
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Innere Medizin 2, Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
Principal Investigator Name
Tobias Böttler
Principal Investigator Email
Tobias.boettler@uniklinik-freiburg.de
Contact Person Name
Tobias Böttler

Hungary

Earliest CTIS Part Ii Submission Date
13-09-2024
Latest Decision Or Authorization Date
15-12-2025
Processing Time Days
458
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Hepatológia, Gasztroenterológia Szakrendelés I.
Principal Investigator Name
Mihaly MAKARA
Principal Investigator Email
Makara.mihaly@mdd.hu
Contact Person Name
Mihaly MAKARA
Contact Person Email
Makara.mihaly@mdd.hu
Site Name
Semmelweis University
Department Name
Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
Principal Investigator Name
Attila SZIJARTO
Principal Investigator Email
szijarto.attila@semmelweis.hu
Contact Person Name
Attila SZIJARTO
Contact Person Email
szijarto.attila@semmelweis.hu
Site Name
High Tech Medical Kft.
Principal Investigator Name
Tamas NYEKY
Principal Investigator Email
ceo@hightechmedicalkft.com
Contact Person Name
Tamas NYEKY
Contact Person Email
ceo@hightechmedicalkft.com

France

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
450
Number Of Sites
15
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hepato-Gastroenterology
Principal Investigator Name
Rémi Collin
Principal Investigator Email
remi.collin@chu-limoges.fr
Contact Person Name
Rémi Collin
Contact Person Email
remi.collin@chu-limoges.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hepato-Gastroenterology
Principal Investigator Name
Eric Nguyen-Khac
Principal Investigator Email
nguyen-khac.eric@chu-amiens.fr
Contact Person Name
Eric Nguyen-Khac
Contact Person Email
nguyen-khac.eric@chu-amiens.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hepato-Gastroenterology
Principal Investigator Name
Marie Lequoy
Principal Investigator Email
marie.lequoy@aphp.fr
Contact Person Name
Marie Lequoy
Contact Person Email
marie.lequoy@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Hepatology and Gastroenterology
Principal Investigator Name
Massimo Levrero
Principal Investigator Email
massimo.levrero@chu-lyon.fr
Contact Person Name
Massimo Levrero
Contact Person Email
massimo.levrero@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hepatology
Principal Investigator Name
Christophe Bureau
Principal Investigator Email
bureau.c@chu-toulouse.fr
Contact Person Name
Christophe Bureau
Contact Person Email
bureau.c@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hepato Gastroenterology and Digestive oncology
Principal Investigator Name
Juliette Foucher
Principal Investigator Email
juliette.foucher@chu-bordeaux.fr
Contact Person Name
Juliette Foucher
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Endocrinology, Diabetes and Metabolic Diseases
Principal Investigator Name
Alexia Rouland
Principal Investigator Email
alexia.rouland@chu-dijon.fr
Contact Person Name
Alexia Rouland
Contact Person Email
alexia.rouland@chu-dijon.fr
Site Name
Assistance Publique Hopitaux De Paris (Villejuif)
Department Name
Hepatology
Principal Investigator Name
Lucia Parlati
Principal Investigator Email
lucia.parlati@aphp.fr
Contact Person Name
Lucia Parlati
Contact Person Email
lucia.parlati@aphp.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hepato Gastroenterology
Principal Investigator Name
Lawrence Serfaty
Principal Investigator Email
lawrence.serfaty@chru-strasbourg.fr
Contact Person Name
Lawrence Serfaty
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Hepato-Gastroenterology
Principal Investigator Name
Stéphanie Faure
Principal Investigator Email
s-faure@chu-montpellier.fr
Contact Person Name
Stéphanie Faure
Contact Person Email
s-faure@chu-montpellier.fr
Site Name
Centre De Recherche Clinique Portes Du Sud
Department Name
Hepatology and Gastroenterology
Principal Investigator Name
Lionel Wander
Principal Investigator Email
l.wander@lesportesdusud.net
Contact Person Name
Lionel Wander
Contact Person Email
l.wander@lesportesdusud.net
Site Name
Assistance Publique Hopitaux De Paris (Villejuif - Gastro-enterology and hepatology)
Department Name
Gastro-enterology and hepatology
Principal Investigator Name
Rodolphe Sobesky
Principal Investigator Email
rodolphe.sobesky@aphp.fr
Contact Person Name
Rodolphe Sobesky
Contact Person Email
rodolphe.sobesky@aphp.fr
Site Name
CHRU De Nancy
Department Name
Hepato-Gastro-Enterology
Principal Investigator Name
Jean-Pierre Bronowicki
Principal Investigator Email
jp.bronowicki@chru-nancy.fr
Contact Person Name
Jean-Pierre Bronowicki
Contact Person Email
jp.bronowicki@chru-nancy.fr
Site Name
Assistance Publique Hopitaux De Paris (Paris - Boulevard De L Hopital)
Department Name
Hepato-Gastroenterology
Principal Investigator Name
Vlad Ratziu
Principal Investigator Email
vlad.ratziu@inserm.fr
Contact Person Name
Vlad Ratziu
Contact Person Email
vlad.ratziu@inserm.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Hepatology
Principal Investigator Name
Albert Tran
Principal Investigator Email
tran.a@chu-nice.fr
Contact Person Name
Albert Tran
Contact Person Email
tran.a@chu-nice.fr

Bulgaria

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
27-01-2026
Processing Time Days
502
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Acibadem City Clinic Tokuda University Hospital EAD
Department Name
Gastroenterology department
Principal Investigator Name
Rozalina Balabanska
Principal Investigator Email
rozabalabanska@abv.bg
Contact Person Name
Rozalina Balabanska
Contact Person Email
rozabalabanska@abv.bg
Site Name
Diagnostic Consultative Centre Ascendent EOOD
Department Name
Cabinet 10
Principal Investigator Name
Stefan Mitev
Principal Investigator Email
drstefanmitev@yahoo.com
Contact Person Name
Stefan Mitev
Contact Person Email
drstefanmitev@yahoo.com
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
Gastroenterology department
Principal Investigator Name
Mariana Radicheva
Principal Investigator Email
dr.mradicheva@gmail.com
Contact Person Name
Mariana Radicheva
Contact Person Email
dr.mradicheva@gmail.com
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
First internal department
Principal Investigator Name
Ilko Kosturkov
Principal Investigator Email
dr_ikosturkov@abv.bg
Contact Person Name
Ilko Kosturkov
Contact Person Email
dr_ikosturkov@abv.bg

Belgium

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
448
Number Of Sites
8
Number Of Participants
16

Sites

Site Name
Hopital Erasme
Department Name
Gastroenterology
Principal Investigator Name
Christophe Moreno
Principal Investigator Email
christophe.moreno@HUBruxelles.be
Contact Person Name
Christophe Moreno
Site Name
UZ Brussel
Department Name
Hepatology
Principal Investigator Name
Helena Degroote
Principal Investigator Email
helena.degroote@uzbrussel.be
Contact Person Name
Helena Degroote
Contact Person Email
helena.degroote@uzbrussel.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Gastroenterology/hepatology
Principal Investigator Name
Charlotte De Vloo
Principal Investigator Email
charlotte.devloo@azdelta.be
Contact Person Name
Charlotte De Vloo
Contact Person Email
charlotte.devloo@azdelta.be
Site Name
Az Maria Middelares Gent
Department Name
Gastroenterology
Principal Investigator Name
Christophe Van Steenkiste
Principal Investigator Email
christophe.vansteenkiste@azmmsj.be
Contact Person Name
Christophe Van Steenkiste
Site Name
Antwerp University Hospital
Department Name
Gastroenterology
Principal Investigator Name
Sven Francque
Principal Investigator Email
sven.francque@uza.be
Contact Person Name
Sven Francque
Contact Person Email
sven.francque@uza.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hepatology
Principal Investigator Name
Nicolas Lanthier
Principal Investigator Email
nicolas.lanthier@uclouvain.be
Contact Person Name
Nicolas Lanthier
Contact Person Email
nicolas.lanthier@uclouvain.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Gastroenterology
Principal Investigator Name
Mathieu Struyve
Principal Investigator Email
mathieu.struyve@zol.be
Contact Person Name
Mathieu Struyve
Contact Person Email
mathieu.struyve@zol.be
Site Name
Hopital Erasme (duplicate entry?)
Department Name
Gastroenterology

Spain

Earliest CTIS Part Ii Submission Date
10-09-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
450
Number Of Sites
11
Number Of Participants
24

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Aparato Digestivo
Principal Investigator Name
Maria Teresa Arias Loste
Principal Investigator Email
ariasloste@gmail.com
Contact Person Name
Maria Teresa Arias Loste
Contact Person Email
ariasloste@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medicina Interna
Principal Investigator Name
Juan Manuel Pericas Pulido
Principal Investigator Email
juanmanuel.pericas@vallhebron.cat
Contact Person Name
Juan Manuel Pericas Pulido
Site Name
Hospital Universitario Torrecardenas
Department Name
Digestivo
Principal Investigator Name
Marta Maria Casado Martin
Principal Investigator Email
mm.casado.m@gmail.com
Contact Person Name
Marta Maria Casado Martin
Contact Person Email
mm.casado.m@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Hepatologia
Principal Investigator Name
Rosa Maria Morillas Cunill
Principal Investigator Email
rmorillas.germanstrias@gencat.cat
Contact Person Name
Rosa Maria Morillas Cunill
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Aparato Digestivo
Principal Investigator Name
Luis Cortes Garcia
Principal Investigator Email
lcortesgmd@gmail.com
Contact Person Name
Luis Cortes Garcia
Contact Person Email
lcortesgmd@gmail.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Unidad Hepatologia y Transplante de Higado
Principal Investigator Name
Luis Ibanez Samaniego
Principal Investigator Email
lisamaniego@gmail.com
Contact Person Name
Luis Ibanez Samaniego
Contact Person Email
lisamaniego@gmail.com
Site Name
Complexo Hospitalario Universitario De Pontevedra
Department Name
Gastroenterologia
Principal Investigator Name
Juan Turnes Vazquez
Principal Investigator Email
juan.turnes.vazquez@sergas.es
Contact Person Name
Juan Turnes Vazquez
Contact Person Email
juan.turnes.vazquez@sergas.es
Site Name
Hospital Universitario Reina Sofia
Department Name
Servicio de Digestivo
Principal Investigator Name
Manuel Rodriguez Peralvarez
Principal Investigator Email
h02ropem@uco.es
Contact Person Name
Manuel Rodriguez Peralvarez
Contact Person Email
h02ropem@uco.es
Site Name
Hospital Del Mar
Department Name
Gastroenterologia
Principal Investigator Name
Montserrat Garcia Retortillo
Principal Investigator Email
mgarciaretortillo@psmar.cat
Contact Person Name
Montserrat Garcia Retortillo
Contact Person Email
mgarciaretortillo@psmar.cat
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Gastroenterologia
Principal Investigator Name
German Soriano Pastor
Principal Investigator Email
gsoriano@santpau.cat
Contact Person Name
German Soriano Pastor
Contact Person Email
gsoriano@santpau.cat
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
F.E.A. Aparato Digestivo
Principal Investigator Name
Esther Molina Perez
Principal Investigator Email
esther.molina.perez@sergas.es
Contact Person Name
Esther Molina Perez
Contact Person Email
esther.molina.perez@sergas.es

Netherlands

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
444
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Stichting Amsterdam UMC
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Bart Takkenberg
Principal Investigator Email
ctis@amsterdamumc.nl
Contact Person Name
Bart Takkenberg
Contact Person Email
ctis@amsterdamumc.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Robert Laheij
Principal Investigator Email
wetenschapsbureau@etz.nl
Contact Person Name
Robert Laheij
Contact Person Email
wetenschapsbureau@etz.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Willem Pieter Brouwer
Principal Investigator Email
w.p.brouwer@erasmusmc.nl
Contact Person Name
Willem Pieter Brouwer
Contact Person Email
w.p.brouwer@erasmusmc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Karel van Erpecum
Principal Investigator Email
k.j.vanerpecum@umcutrecht.nl
Contact Person Name
Karel van Erpecum
Contact Person Email
k.j.vanerpecum@umcutrecht.nl

Poland

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
572
Number Of Sites
7
Number Of Participants
22

Sites

Site Name
Mtz Clinical Research Powered By Pratia
Department Name
MTZ Clinical Research Powered by Pratia
Principal Investigator Name
Maciej Murawski
Principal Investigator Email
mmurawski@pratia.pl
Contact Person Name
Maciej Murawski
Contact Person Email
mmurawski@pratia.pl
Site Name
Futuremeds Sp. z o.o. (Cracow)
Department Name
FutureMeds Krakow
Principal Investigator Name
Piotr Rozpondek
Principal Investigator Email
feasibility@futuremeds.com
Contact Person Name
Piotr Rozpondek
Contact Person Email
feasibility@futuremeds.com
Site Name
Futuremeds Sp. z o.o. (Lodz)
Department Name
FutureMeds Łódź
Principal Investigator Name
Magdalena Olszewska-Jander
Principal Investigator Email
magdalena.olszewska@futuremeds.com
Contact Person Name
Magdalena Olszewska-Jander
Site Name
ID Clinic Arkadiusz Pisula
Principal Investigator Name
Ewa Janczewska
Principal Investigator Email
e.janczewska@poczta.fm
Contact Person Name
Ewa Janczewska
Contact Person Email
e.janczewska@poczta.fm
Site Name
Santa Sp. z o.o.
Department Name
Santa Familia PTG Łódź
Principal Investigator Name
Maciej Jabłkowski
Principal Investigator Email
badania.kliniczne@swietarodzina.com.pl
Contact Person Name
Maciej Jabłkowski
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Profesor Kierkuś
Principal Investigator Name
Jarosław Kierkuś
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@med-net.pl
Site Name
Futuremeds Sp. z o.o. (Wroclaw)
Department Name
FutureMeds Wrocław
Principal Investigator Name
Ewa Krecipro-Nizińska
Principal Investigator Email
ewa.krecipro-nizinska@futuremeds.com
Contact Person Name
Ewa Krecipro-Nizińska

Sponsor

Primary sponsor

Full Name
89bio Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Medpace Finland Oy
Responsibilities
Multiple sponsor duties including imaging and operational support (codes provided in record)
Name
Altasciences Compagnie Inc.
Responsibilities
Sponsor duties code:4
Name
Medassessment Inc.
Responsibilities
Sponsor duties code:8
Name
Cirion Biopharma Research Inc.
Responsibilities
Sponsor duties code:4
Name
Fisher Clinical Services Inc.
Responsibilities
Sponsor duties code:14
Name
Clinchoice Limited
Responsibilities
Sponsor duties code:10 and code:6

Third parties

  • {"country":"United States","full_name":"Medassessment Inc.","duties_or_roles":"code:8","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"Sweden","full_name":"Antaros Medical AB","duties_or_roles":"code:15 (MRI central reading)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"CIRION Biopharma Research Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"code:14, code:3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"codes:1,11,12,13,15 (imaging),2,4,5,8,9","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Clinchoice Limited","duties_or_roles":"code:10, code:6","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Pegozafermin
Active Substance
BIO89-100
Modality
Peptide/protein/enzyme
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
Investigational product (no marketing authorisation specified in provided record)
Maximum Dose
30 mg per day
Investigational Product Name
Placebo for pegozafermin. combined integral administration device: pre-filled syringe - please refer to the impd pegozafermin section 3.2.p.7 container closure system for detailed description.
Modality
Other

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