Clinical trial • Phase II • Gastroenterology

GSK4532990A for Non-alcoholic Fatty Liver Disease | Nonalcoholic steatohepatitis (NASH)

Phase II trial of GSK4532990A for Non-alcoholic Fatty Liver Disease | Nonalcoholic steatohepatitis (NASH).

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Non-alcoholic Fatty Liver Disease | Nonalcoholic steatohepatitis (NASH)
Trial Stage
Phase II
Drug Modality
mRNA

Key dates

Initial CTIS Submission Date
04-12-2023
First CTIS Authorization Date
08-03-2024

Trial design

Randomised, 0.9% sodium chloride injection (placebo) — dose/schedule not specified-controlled Phase II trial across 29 sites in France, Spain, Belgium and others.

Randomised
Yes
Comparator
0.9% Sodium Chloride Injection (placebo) — dose/schedule not specified
Target Sample Size
214
Trial Duration For Participant
364

Eligibility

Recruits 214 Vulnerable population not selected. Participants must be capable of giving signed informed consent prior to any study-specific procedures..

Pregnancy Exclusion
"A female participant is eligible to participate, if she is not pregnant or breastfeeding and one of the following conditions applies: • Is a woman of nonchildbearing potential (WONCBP) as defined in Section 10.4 Contraception and Barrier Guidance OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4. Contraceptive measures must start from the time of negative serum pregnancy test at screening and at least 28 days before first administration of study intervention. Contraceptive measures should then continue during the study intervention period, and for at least 18 weeks after the last administration of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention). o A WOCBP must have a negative highly sensitive pregnancy test (serum or urine as required by local regulations) within 24 hours before the first dose of study intervention, see Section 8.2.5 Pregnancy Testing. "
Vulnerable Population
Vulnerable population not selected. Participants must be capable of giving signed informed consent prior to any study-specific procedures.

Inclusion criteria

  • {"criterion_text":"- Participant must be 18 to 75 years of age inclusive, at the time of screening.\n- Body Mass Index (BMI) ≥25 kilogram per meter square (kg/m^2) (all ethnic origins) except for Asian participants who qualify for the study with BMI ≥23 kg/m2 at Screening.\n- In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease. Metabolic syndrome may include type 2 diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension.\n- \"The liver biopsy must show a NAS ≥4 with at least 1 point each in steatosis, inflammation, and ballooning and Fibrosis 3 using NASH CRN Scoring System, confirmed by central scoring.\"\n- Capable of giving signed informed consent prior to the performance of any study-specific procedures\n- Able and willing to comply with all study assessments.\n- \"A female participant is eligible to participate, if she is not pregnant or breastfeeding and one of the following conditions applies: • Is a woman of nonchildbearing potential (WONCBP) as defined in Section 10.4 Contraception and Barrier Guidance OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4. Contraceptive measures must start from the time of negative serum pregnancy test at screening and at least 28 days before first administration of study intervention. Contraceptive measures should then continue during the study intervention period, and for at least 18 weeks after the last administration of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention). o A WOCBP must have a negative highly sensitive pregnancy test (serum or urine as required by local regulations) within 24 hours before the first dose of study intervention, see Section 8.2.5 Pregnancy Testing. \""}

Exclusion criteria

  • {"criterion_text":"- Current alcohol consumption ≥14 standard drinks (24 units, 196 g ethanol) per week for females or ≥21 standard drinks (37 units, 294g ethanol) per week for males. One standard drink is equivalent to: 12 US fluid ounces (oz) beer (5% alcohol); 5 oz of wine (12% alcohol), or 1.5 oz of 80 proof spirits (40% alcohol). \n- Weight reduction surgery (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1.\n- History of cancer within previous 2 years from Screening 1, except adequately"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- \"Achieving greater or equal to 1 stage improvement in histological fibrosis (Clinical Research Network [CRN] scoring) with no worsening of NASH (defined as no increase in the NAFLD Activity Score [NAS] for steatosis, ballooning, or inflammation) at 52 weeks. \"","definition_or_measurement_approach":"Histological fibrosis assessed by Clinical Research Network (CRN) scoring; no worsening of NASH defined as no increase in NAFLD Activity Score (NAS) components for steatosis, ballooning, or inflammation; assessed at 52 weeks."}
  • {"endpoint_text":"- \"Achieving NASH resolution with no worsening of fibrosis (defined as no increase in CRN fibrosis score) at 52 weeks. Resolution of NASH is defined as a ballooning score of 0 and an inflammation score of 0-1. \"","definition_or_measurement_approach":"NASH resolution defined as a ballooning score of 0 and an inflammation score of 0-1; no worsening of fibrosis defined as no increase in CRN fibrosis score; assessed at 52 weeks."}

Recruitment

Planned Sample Size
214
Recruitment Window Months
47
Consent Approach
Adult participants must be capable of giving signed informed consent prior to any study-specific procedures. Multiple site-specific subject information and informed consent forms are provided (document titles show L1_ICF_Main and regional variants). ICFs are available in multiple languages (English, French, Spanish, Greek, Italian, Dutch/BE_NL indicated among document versions). No assent process for minors (minors excluded).

Methods

  • K2_Flyer / K2_Poster (paper/clinic materials) — document titles indicate use of flyers/posters for patient-facing recruitment (country-specific versions present).
  • K2_Patient Letter / K2_Recruitment Letter (patient mail/letters) — patient invitation/letter templates (country-specific versions).
  • K2_HCP referral letter_EN (healthcare professional referral) — letter to HCPs to refer eligible patients.
  • K1_Study Planner / K1_Study Planner BE_* (study planner materials) — site-level planning materials to support recruitment.
  • Appointment reminder card and counseling sheets (K2_Appt Reminder Card; K2_Counseling Sheet).
  • Recruitment/informed consent procedure documents (K1_Recruitment Procedure; K1_Recruitment and Informed Consent Procedure) and instructional videos (Illustration video liver biopsy_Redacted, Script video liver biopsy_Redacted) for patient information.

Geography

Total Number Of Sites
29
Total Number Of Participants
52

France

Earliest CTIS Part Ii Submission Date
05-01-2024
Latest Decision Or Authorization Date
17-09-2025
Processing Time Days
621
Number Of Sites
6
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Hôpital Larrey - Service d'Hépato-Gastro-Entérologie et Oncologie Digestive
Contact Person Name
Jérôme BOURSIER
Contact Person Email
jeboursier@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
GH Sud - Hôpital Haut Lévêque - Service Hépato-Gastroentérologie et Oncologie Digestive CMC Magellan
Contact Person Name
Juliette FOUCHER
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hôpital de la Pitié-Salpêtrière - Service Hépato Gastro Entérologie
Contact Person Name
Vlad RATZIU
Contact Person Email
vlad.ratziu@inserm.fr
Site Name
Centre Hospitalier Lyon Sud
Department Name
Service d'Endocrinologie-Diabète-Nutrition
Contact Person Name
Cyrielle CAUSSY
Contact Person Email
cyrielle.caussy@chu-lyon.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hôpital Dupuytren 1 - Service Hépato-Gastroentérologie et Nutrition
Contact Person Name
Véronique LOUSTAUD-RATTI
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
HUS Nouvel Hôpital Civil - Service Hépato Digestif - Service d’Hépato-Gastroentérologie
Contact Person Name
Lawrence SERFATY

Spain

Earliest CTIS Part Ii Submission Date
05-01-2024
Latest Decision Or Authorization Date
19-09-2025
Processing Time Days
623
Number Of Sites
9
Number Of Participants
18

Sites

Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Digestive
Contact Person Name
Raúl Andrade Bellido
Contact Person Email
andrade@uma.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Digestive
Contact Person Name
Juan Manuel Pericás Pullido
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Digestive
Contact Person Name
Javier Ampuero Herrojo
Contact Person Email
javi.ampuero@gmail.com
Site Name
Parc Tauli Hospital Universitari
Department Name
Digestive
Contact Person Name
Meritxell Casas Rodrigo
Contact Person Email
secdigestiu@tauli.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Digestive
Contact Person Name
Mónica Barreales Valbuena
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Digestive
Contact Person Name
Paula Iruzubieta Coz
Contact Person Email
paula.iruzubieta@scsalud.es
Site Name
Complexo Hospitalario Universitario De Pontevedra
Department Name
Digestive
Contact Person Name
Juan Turnes Vázquez
Contact Person Email
juan.turnes.vazquez@sergas.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Digestive
Contact Person Name
José Luis Calleja Panero
Contact Person Email
jlcallejap@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Digestive
Contact Person Name
Agustín Albillos Martínez
Contact Person Email
agustin.albillos@uah.es

Belgium

Earliest CTIS Part Ii Submission Date
05-01-2024
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
626
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Hopital Erasme
Department Name
Dept of Gastroenterology/HepatoPancreatology/Digestive Oncology
Contact Person Name
Christophe Moreno
Contact Person Email
contact@erasme.ulb.ac.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hepato-Gasteroenterology
Contact Person Name
Nicolas Lanthier
Site Name
Antwerp University Hospital
Department Name
Gastroenterology and Hepatology
Contact Person Name
Sven Franque
Contact Person Email
studies.hepatologie@uza.be

Italy

Earliest CTIS Part Ii Submission Date
05-01-2024
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
626
Number Of Sites
9
Number Of Participants
12

Sites

Site Name
Casa Sollievo Della Sofferenza
Department Name
UOSD Epatologia
Contact Person Name
Alessandra Mangia
Contact Person Email
a.mangia@operapadrepio.it
Site Name
Careggi University Hospital
Department Name
SOD Gastroenterologia
Contact Person Name
Andrea Galli
Contact Person Email
andrea.galli@unifi.it
Site Name
Azienda Ospedale-Universita Padova
Department Name
U.O.C. Gastroenterologia
Contact Person Name
Francesco Paolo Russo
Contact Person Email
francescopaolo.russo@unipd.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Struttura Complessa di Medicina ad indirizzo Metabolico Nutrizionale
Contact Person Name
Fabio Nascimbeni
Contact Person Email
nascimbeni.fabio@aou.mo.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
U.O. di Gastroenterologia
Contact Person Name
Salvatore Petta
Contact Person Email
salvatore.petta@unipa.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
U.O.C Medicina Generale ad Indirizzo Metabolico
Contact Person Name
Anna Ludovica Fracanzani
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Dipartimento Fisiopatologia e Medicina Trasfusionale
Contact Person Name
Luca Valenti
Contact Person Email
luca.valenti@unimi.it
Site Name
Humanitas Research Hospital
Department Name
U.O. di Medicina Interna ed Epatologia, Dip. di Gastroenterologia
Contact Person Name
Alessio Aghemo
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Medicina Interna e del Trapianto di Fegato
Contact Person Name
Luca Miele

Greece

Earliest CTIS Part Ii Submission Date
05-01-2024
Latest Decision Or Authorization Date
03-10-2025
Processing Time Days
637
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
Fourth Internal Medicine Clinic
Contact Person Name
Emmanouil Sinakos
Contact Person Email
esinakos@auth.gr
Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
Fourth Internal Medicine Clinic, Gastroenterology Department
Contact Person Name
Ioannis Goulis
Contact Person Email
igoulis@auth.gr

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Contract research organisations

Name
Sermes CRO
Responsibilities
Patient fee reimbursement

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Singapore","full_name":"Histoindex Pte. Ltd.","duties_or_roles":"Digital pathology","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alliance Pharma Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Modern Diagnostic Imaging Methods A.E.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Fm Richard Et Associes","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Pathai Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Bioiatriki Private Medical Polyclinic S.A.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"IDMC","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"Patient fee reimbursement","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Athens Medical Center S.A.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"Medicine product destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Metabolon Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Denmark","full_name":"Nordic Bioscience A/S","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Affidea Thessaloniki Private Polyclinic Iatriki Monoprosopi S.A.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"Veramed Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
GSK4532990A
Active Substance
GSK4532990A
Modality
mRNA
Routes Of Administration
SUBCUTANEOUS USE
Route
SUBCUTANEOUS USE
Maximum Dose
200 mg/ml
Investigational Product Name
0.9% Sodium Chloride Injection
Modality
Other

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