Clinical trial • Phase III • Endocrinology
BIO89-100 for Metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis | Nonalcoholic steatohepatitis (NASH) with fibrosis
Phase III trial of BIO89-100 for Metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis | Nonalcoholic steatohepatitis (NASH) with fibrosis.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis | Nonalcoholic steatohepatitis (NASH) with fibrosis
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 09-04-2024
- First CTIS Authorization Date
- 29-07-2024
Trial design
Randomised, placebo (placebo for pegozafermin. combined integral administration device: pre-filled syringe). dose/schedule not specified in the provided record.-controlled, adaptive Phase III trial in Netherlands, France, Czechia and others.
- Randomised
- Yes
- Comparator
- Placebo (Placebo for pegozafermin. combined integral administration device: pre-filled syringe). Dose/schedule not specified in the provided record.
- Adaptive
- True, interim analysis planned: At interim analysis evaluate effect of pegozafermin compared to placebo on liver histology at 52 weeks relative to baseline biopsy; final analysis at study completion for clinical outcome composite endpoint. No dose escalation rules or stopping rules are specified in the provided record.
- Target Sample Size
- 1090
- Trial Duration For Participant
- 1080
Eligibility
Recruits 1090 The trial record flags isVulnerablePopulationSelected = true. Informed consent procedures are documented (multiple L1 SIS and ICF documents listed, including Main ICF, Pre-screening ICF, Pregnancy/Pregnant Partner ICF variants). Participants are adults (18-80) so consent is to be provided by the participant; specific ICFs for pregnancy and pregnant partners are available. No assent procedures for minors are provided in the record..
- Pregnancy Exclusion
- 1_Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
- Vulnerable Population
- The trial record flags isVulnerablePopulationSelected = true. Informed consent procedures are documented (multiple L1 SIS and ICF documents listed, including Main ICF, Pre-screening ICF, Pregnancy/Pregnant Partner ICF variants). Participants are adults (18-80) so consent is to be provided by the participant; specific ICFs for pregnancy and pregnant partners are available. No assent procedures for minors are provided in the record.
Inclusion criteria
- {"criterion_text":"- 1_Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)"}
- {"criterion_text":"- 2_Biopsy-confirmed MASH, either within 6 months of screening visit [with additional requirements] or obtained during screening period in: a_ Group A: Subjects with fibrosis stage F2 or F3 per NASH CRN System and NAS >=4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation b_ Group B: Subjects who do not meet NAS criteria for Group A and have F3 fibrosis and a score of at least 1 in steatosis and at least 1 in lobular inflammation. This will include subjects with NAS <4 and/or a ballooning degradation score of 0."}
- {"criterion_text":"- 3_Body mass index (BMI) at Screening ≥25.0 kg/m2 (≥23 kg/m2 for Asian countries)"}
Exclusion criteria
- {"criterion_text":"- 1_Chronic liver diseases other than MASH/NASH"}
- {"criterion_text":"- 2_Evidence of cirrhosis"}
- {"criterion_text":"- 3_Have type 1 diabetes or poorly controlled type 2 diabetes"}
- {"criterion_text":"- 4_Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=250 U/L"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1_Proportion of participants achieving the co-primary endpoints measured at 52 weeks of: _ Improvement in fibrosis by ≥1 stage without worsening of steatohepatitis -resolution of steatohepatitis without worsening of fibrosis","definition_or_measurement_approach":"Measured at 52 weeks relative to baseline biopsy by liver histology (baseline and Week 52 biopsy comparisons)."}
Secondary endpoints
- {"endpoint_text":"- 1_Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52","definition_or_measurement_approach":"MRI-PDFF change from baseline at Week 52."}
- {"endpoint_text":"- 2_Percent Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36","definition_or_measurement_approach":"Percent change from baseline in ALT measured at Week 52 and Month 36."}
- {"endpoint_text":"- 3_Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events Up to Month 36","definition_or_measurement_approach":"Time-to-event analysis of protocol-specified composite clinical events up to Month 36."}
- {"endpoint_text":"- 4_Absolute change from baseline in ELF score at 52 weeks","definition_or_measurement_approach":"Absolute change from baseline in ELF score at Week 52."}
Recruitment
- Digital Remote Recruitment
- True, digital/remote methods are planned including Social Media Kits, MoA video scripts/storyboards and online materials indicated in the K2 recruitment material (Social Media Kit, MoA video) documents.
- Planned Sample Size
- 1090
- Recruitment Window Months
- 25
- Consent Approach
- Informed consent is via participant-signed ICFs (Main ICF documents present). Age-specific approach: participants are adults (18-80) and provide their own consent; pre-screening ICFs are available. There are pregnancy- and pregnant-partner-specific ICF documents. ICFs and patient-facing materials are available in multiple languages (document titles show English, French, German, Italian, Polish, Bulgarian, Dutch, Spanish, Czech and country-specific versions).
Methods
- Brochures and informational brochures (K2 recruitment material_Brochure) targeted to potential participants
- Lay article summaries and information sheets (K2 Recruitment material_Lay Article Summary / Info Sheet) for patient-facing education
- Social Media Kit (country-specific Social Media Kit documents) for digital outreach
- MoA (mechanism of action) video scripts/storyboards and videos (K2 MoA Video Script / MoA Video Storyboard) for awareness
- ABPM Handouts (ambulatory blood pressure monitoring handouts) as part of recruitment materials
- Country-specific recruitment arrangements documents (K1_Recruitment arrangements) prepared for each Member State (e.g., NL, FR, CZ, ES, PL, IT, DE, AT, BG, BE) describing local recruitment approach and materials
Geography
- Total Number Of Sites
- 84
- Total Number Of Participants
- 1090
Netherlands
- Earliest CTIS Part Ii Submission Date
- 01-07-2024
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 655
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Internal Vascular Medicine
- Contact Person Name
- Onno Holleboom
- Contact Person Email
- ctis@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Hepatology
- Contact Person Name
- Joep de Bruijne
- Contact Person Email
- j.debruijne-7@umcutrecht.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Gastroenterology & Hepatology
- Contact Person Name
- Willem Pieter Brouwer
- Contact Person Email
- w.p.brouwer@erasmusmc.nl
France
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 680
- Number Of Sites
- 16
- Number Of Participants
- 60
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Gastroenterology
- Contact Person Name
- Philippe Mathurin
- Contact Person Email
- philippe.mathurin@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Head of Hepato-Gastroenterology Department
- Contact Person Name
- Jérôme Boursier
- Contact Person Email
- jeboursier@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Hepatology
- Contact Person Name
- Albert Tran
- Contact Person Email
- tran.a@chu-nice.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Gastro-enterology and hepatology
- Contact Person Name
- Rodolphe Sobesky
- Contact Person Email
- rodolphe.sobesky@aphp.fr
- Site Name
- Clinique Pasteur
- Department Name
- Gastro-enterology, Endoscopy and Hepatic Diseases
- Contact Person Name
- Maeva Guillaume
- Contact Person Email
- mguillaume@clinique-pasteur.com
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Hepato-Gastroenterology
- Contact Person Name
- Lawrence Serfaty
- Contact Person Email
- lawrence.serfaty@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hepatology
- Contact Person Name
- Christophe Bureau
- Contact Person Email
- bureau.c@chu-toulouse.fr
- Site Name
- Hospital La Croix Rousse Hcl
- Department Name
- Hepatology and Gastroenterology
- Contact Person Name
- Marianne Maynard-Muet
- Contact Person Email
- marianne.maynard-muet@chu-lyon.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Endocrinology, Diabetes, Nutrition Department
- Contact Person Name
- Cyrielle Caussy
- Contact Person Email
- Cyrielle.caussy@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Paris site)
- Department Name
- Hepatology
- Contact Person Name
- Lucia Parlati
- Contact Person Email
- lucia.parlati@aphp.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Hepato-Gastroenterology
- Contact Person Name
- Rémi Collin
- Contact Person Email
- remi.collin@chu-limoges.fr
- Site Name
- Centre De Recherche Clinique Portes Du Sud
- Department Name
- Hepatology and Gastroenterology
- Contact Person Name
- Lionel Wander
- Contact Person Email
- l.wander@lesportesdusud.net
- Site Name
- Assistance Publique Hopitaux De Paris (Hopital site)
- Department Name
- Hepato-Gastroenterology
- Contact Person Name
- Vlad Ratziu
- Contact Person Email
- vlad.ratziu@inserm.fr
- Site Name
- Hopital Beaujon
- Department Name
- Hepatology
- Contact Person Name
- Laurent Castera
- Contact Person Email
- laurent.castera@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hepato-Gastro-Enterology
- Contact Person Name
- Marion Khaldi
- Contact Person Email
- marion.khaldi@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hepato Gastroenterology and Digestive oncology
- Contact Person Name
- Juliette Foucher
- Contact Person Email
- juliette.foucher@chu-bordeaux.fr
Czechia
- Earliest CTIS Part Ii Submission Date
- 12-08-2025
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 247
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Research Site s.r.o.
- Contact Person Name
- Václav Hejda
- Contact Person Email
- hejdav@researchsite.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Oddělení gastroenterologie, hepatologie a pankreatologie
- Contact Person Name
- Adam Vašura
- Contact Person Email
- adam.vasura@fno.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- IGEK
- Contact Person Name
- Jan Šlapák
- Contact Person Email
- slapak.jan@fnbrno.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 02-07-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 657
- Number Of Sites
- 16
- Number Of Participants
- 45
Poland
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 643
- Number Of Sites
- 10
- Number Of Participants
- 35
Italy
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 680
- Number Of Sites
- 13
- Number Of Participants
- 35
Germany
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 672
- Number Of Sites
- 6
- Number Of Participants
- 20
Austria
- Earliest CTIS Part Ii Submission Date
- 16-09-2025
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 220
- Number Of Sites
- 5
- Number Of Participants
- 10
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 01-07-2024
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 659
- Number Of Sites
- 5
- Number Of Participants
- 15
Belgium
- Earliest CTIS Part Ii Submission Date
- 01-07-2024
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 676
- Number Of Sites
- 7
- Number Of Participants
- 25
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 operational activities (codes listed: 1,11,12,13,15 (ECG, imaging),2,4,5,8,9)
- Name
- Clinchoice Limited
- Responsibilities
- Sponsor duties codes 10,6 (as listed in record)
- Name
- Altasciences Compagnie Inc.
- Responsibilities
- Sponsor duty code 4
Third parties
- {"country":"United States","full_name":"Medassessment Inc.","duties_or_roles":"[{\"code\":\"8\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"[{\"code\":\"14\"},{\"code\":\"3\"}]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"[{\"code\":\"14\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Sweden","full_name":"Antaros Medical AB","duties_or_roles":"[{\"code\":\"15\",\"value\":\"MRI central reading\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"CIRION Biopharma Research Inc.","duties_or_roles":"[{\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Clinchoice Limited","duties_or_roles":"[{\"code\":\"10\"},{\"code\":\"6\"}]","organisation_type":"Pharmaceutical company"}
- {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"[{\"code\":\"1\"},{\"code\":\"11\"},{\"code\":\"12\"},{\"code\":\"13\"},{\"code\":\"15\",\"value\":\"ECG, imaging\"},{\"code\":\"2\"},{\"code\":\"4\"},{\"code\":\"5\"},{\"code\":\"8\"},{\"code\":\"9\"}]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Pegozafermin
- Active Substance
- BIO89-100
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Maximum Dose
- Max daily dose 44 mg; max total dose 4320 mg
- 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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