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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05583344
Registration number
NCT05583344
Ethics application status
Date submitted
13/10/2022
Date registered
17/10/2022
Date last updated
15/03/2024
Titles & IDs
Public title
Phase 2b Study of GSK4532990 in Adults With NASH
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Scientific title
17 ß-Hydroxysteroid Dehydrogenase Type 13 Minimization for the Treatment of NASH (HORIZON): A Double-Blind, Placebo-Controlled Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults With Nonalcoholic Steatohepatitis
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Secondary ID [1]
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2022-002538-14
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Secondary ID [2]
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218672
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Universal Trial Number (UTN)
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Trial acronym
HORIZON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Fatty Liver Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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0
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0
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Liver
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Metabolic and Endocrine
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0
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0
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Metabolic disorders
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Diet and Nutrition
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GSK4532990
Treatment: Drugs - Placebo
Experimental: High Dose GSK4532990 -
Experimental: Low Dose GSK4532990 -
Placebo Comparator: Placebo -
Treatment: Drugs: GSK4532990
GSK4532990 will be administered.
Treatment: Drugs: Placebo
Placebo will be administered.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving = 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - F3 Cohort
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Assessment method [1]
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Improvement in histological fibrosis is assessed with Clinical research network (CRN) Scoring. No worsening of NASH is defined as no increase in the NAFLD Activity Score (NAS) for steatosis, ballooning, or inflammation.
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Timepoint [1]
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At Week 52
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Primary outcome [2]
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Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - F3 Cohort
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Assessment method [2]
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NASH resolution is defined as a ballooning score of 0 and an inflammation score of 0-1. No worsening of fibrosis is defined as no increase in CRN fibrosis score.
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Timepoint [2]
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At Week 52
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Secondary outcome [1]
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Percentage of Participants Achieving = 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [1]
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Improvement in histological fibrosis is assessed with Clinical research network (CRN) Scoring. No worsening of NASH is defined as no increase in the NAFLD Activity Score (NAS) for steatosis, ballooning, or inflammation.
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Timepoint [1]
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At Week 52
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Secondary outcome [2]
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Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [2]
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NASH resolution is defined as a ballooning score of 0 and an inflammation score of 0-1. No worsening of fibrosis is defined as no increase in CRN fibrosis score.
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Timepoint [2]
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At Week 52
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Secondary outcome [3]
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Change from baseline in Pro-peptide of type III collagen (Pro-C3) - F3 Cohort
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Assessment method [3]
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Timepoint [3]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [4]
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Change from baseline in liver fat using Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) - F3 Cohort
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Assessment method [4]
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Timepoint [4]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [5]
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Change from baseline in Liver stiffness measurement (LSM) by Vibration-controlled transient elastography (VCTE) - F3 Cohort
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Assessment method [5]
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Timepoint [5]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [6]
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Change from baseline in Enhanced Liver Fibrosis (ELF) Score - F3 Cohort
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Assessment method [6]
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The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers, including tissue inhibitor of metalloproteinases-1 (TIMP-1), type III procollagen (PIIINP), and hyaluronic acid (HA). The ELF score is used as a prognostic marker for disease progression: ELF score < 9.8 : Low risk of progression, ELF score 9.8 to < 11.3 : Moderate risk of progression and ELF score > = 11.3 : High risk of progression.
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Timepoint [6]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [7]
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Percentage of Participants Achieving =30% relative reduction in liver fat from baseline using MRI-PDFF at Week 24- F3 Cohort
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Assessment method [7]
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Timepoint [7]
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At Week 24
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Secondary outcome [8]
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Percentage of Participants Achieving =30% relative reduction in liver fat from baseline using MRI-PDFF at Week 52 - F3 Cohort
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Assessment method [8]
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Timepoint [8]
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At Week 52
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Secondary outcome [9]
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Change from Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl transferase (GGT) (Units Per Liter) - F3 Cohort
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Assessment method [9]
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Timepoint [9]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [10]
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Change from baseline in Pro-peptide of type III collagen (Pro-C3) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [10]
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Timepoint [10]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [11]
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Change from baseline in liver fat using Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [11]
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Timepoint [11]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [12]
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Change from baseline in Liver stiffness measurement (LSM) by Vibration-controlled transient elastography (VCTE) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [12]
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Timepoint [12]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [13]
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Change from baseline in Enhanced Liver Fibrosis (ELF) Score - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [13]
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The ELF score will be calculated using a published algorithm combining the values of a set of extracellular matrix markers, including tissue inhibitor of metalloproteinases-1 (TIMP-1), type III procollagen (PIIINP), and hyaluronic acid (HA). The ELF score is used as a prognostic marker for disease progression: ELF score < 9.8 : Low risk of progression, ELF score 9.8 to < 11.3 : Moderate risk of progression and ELF score > = 11.3 : High risk of progression.
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Timepoint [13]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [14]
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Percentage of Participants Achieving =30% relative reduction in liver fat from baseline using MRI-PDFF at Week 24 - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [14]
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Timepoint [14]
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At Week 24
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Secondary outcome [15]
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Percentage of Participants Achieving =30% relative reduction in liver fat from baseline using MRI-PDFF at Week 52 - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [15]
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Timepoint [15]
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At Week 52
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Secondary outcome [16]
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Change from Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl transferase (GGT) (Units Per Liter) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [16]
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Timepoint [16]
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Baseline (Day 1) and at Week 24 and 52
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Secondary outcome [17]
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Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - F3 Cohort
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Assessment method [17]
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Timepoint [17]
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Up to Week 66
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Secondary outcome [18]
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Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury) - F3 Cohort
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Assessment method [18]
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Timepoint [18]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [19]
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Change from Baseline in Vital Signs - Temperature (Celsius) - F3 Cohort
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Assessment method [19]
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Timepoint [19]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [20]
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Change from Baseline in Vital Signs - Heart Rate (Beats per minute) - F3 Cohort
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Assessment method [20]
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Timepoint [20]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [21]
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Change from Baseline in Vital Signs - Respiratory Rate (Breaths per minute) - F3 Cohort
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Assessment method [21]
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Timepoint [21]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [22]
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Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - F3 Cohort
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Assessment method [22]
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0
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Timepoint [22]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [23]
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Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - F4 Cohort
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Assessment method [23]
0
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Timepoint [23]
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Up to Week 66
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Secondary outcome [24]
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Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury) - F4 Cohort
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Assessment method [24]
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0
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Timepoint [24]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [25]
0
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Change from Baseline in Vital Signs - Temperature (Celsius) - F4 Cohort
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Assessment method [25]
0
0
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Timepoint [25]
0
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Baseline (Day 1) and up to Week 52
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Secondary outcome [26]
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Change from Baseline in Vital Signs - Heart Rate (Beats per minute) - F4 Cohort
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Assessment method [26]
0
0
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Timepoint [26]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [27]
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Change from Baseline in Vital Signs - Respiratory Rate (Breaths per minute) - F4 Cohort
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Assessment method [27]
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0
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Timepoint [27]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [28]
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Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - F4 Cohort
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Assessment method [28]
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Timepoint [28]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [29]
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Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [29]
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0
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Timepoint [29]
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Up to Week 66
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Secondary outcome [30]
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Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [30]
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0
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Timepoint [30]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [31]
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Change from Baseline in Vital Signs - Temperature (Celsius) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [31]
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Timepoint [31]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [32]
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Change from Baseline in Vital Signs - Heart Rate (Beats per minute) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [32]
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Timepoint [32]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [33]
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Change from Baseline in Vital Signs - Respiratory Rate (Breaths per minute) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [33]
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0
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Timepoint [33]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [34]
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Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - Pooled Cohort (F3 participants and F4 participants)
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Assessment method [34]
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0
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Timepoint [34]
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Baseline (Day 1) and up to Week 52
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Secondary outcome [35]
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Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 - F3 Cohort
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Assessment method [35]
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Timepoint [35]
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Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
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Secondary outcome [36]
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Maximum observed concentration (Cmax) of GSK4532990- F3 Cohort
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Assessment method [36]
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Timepoint [36]
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Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
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Secondary outcome [37]
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Percentage of Participants with Anti-drug Antibodies (ADA) to GSK4532990- F3 Cohort
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Assessment method [37]
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Timepoint [37]
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Up to Week 52
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Secondary outcome [38]
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Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 - F4 Cohort
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Assessment method [38]
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Timepoint [38]
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Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
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Secondary outcome [39]
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Maximum observed concentration (Cmax) of GSK4532990- F4 Cohort
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Assessment method [39]
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Timepoint [39]
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Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
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Secondary outcome [40]
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Percentage of Participants with Anti-drug Antibodies (ADA) to GSK4532990- F4 Cohort
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Assessment method [40]
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Timepoint [40]
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Up to Week 52
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Eligibility
Key inclusion criteria
- 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.
- 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.
- A liver biopsy at baseline showing NAFLD Activity Score (NAS) >=4 with at least 1
point each in steatosis, inflammation and ballooning and either Fibrosis 3 or Fibrosis
4 using NASH CRN Scoring System.
- Able and willing to comply with all study assessments, including a liver biopsy at
Week 52.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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.
- Weight reduction surgery or procedures (including gastric banding and intragastric
balloon insertion) within 2 years of Screening 1 and/or planned during the study.
- History of cancer within previous 2 years from Screening 1, except basal or squamous
cell carcinoma of the skin or in situ cervical carcinoma or any other type of cancer
which has been treated medically or surgically with curative outcome.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
15/12/2025
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Actual
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Sample size
Target
246
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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GSK Investigational Site - Campbelltown
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Recruitment hospital [2]
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GSK Investigational Site - Nedlands
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Recruitment hospital [3]
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GSK Investigational Site - Perth
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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0
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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Colorado
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Florida
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United States of America
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Georgia
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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State/province [11]
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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Nevada
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United States of America
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Tucumán
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Argentina
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Santa Fe
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Belgium
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Brussels
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Belgium
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Bruxelles
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Belgium
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Edegem
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Canada
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Alberta
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Canada
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Ontario
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France
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Angers Cedex 9
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France
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France
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Paris Cedex 13
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France
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Pessac cedex
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France
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Pierre-Bénite
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France
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Strasbourg Cedex
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Greece
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Athens
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Greece
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Rio
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Greece
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Thessaloniki
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India
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Assam
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India
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Gujarat
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India
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Maharashtra
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India
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India
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India
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India
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Italy
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Italy
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Italy
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Italy
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Italy
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Japan
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Japan
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Japan
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Nagano
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Japan
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Nagasaki
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Japan
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Nara
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Saga
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Japan
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Shimane
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Japan
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Yamanashi
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Korea, Republic of
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Incheon
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Sevilla
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Turkey
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Kocaeli
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Turkey
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Rize
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United Kingdom
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Staffordshire
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United Kingdom
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Barnsley
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United Kingdom
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Liverpool
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London
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Manchester
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United Kingdom
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Nottingham
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Funding & Sponsors
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Commercial sector/Industry
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Name
GlaxoSmithKline
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Summary
Brief summary
The purpose of this study is to measure improvements in liver fibrosis and inflammation with
GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy
(F3 or F4). The study duration will be up to 76 weeks including the screening period. The
treatment duration will be up to 52 weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05583344
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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US GSK Clinical Trials Call Center
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877-379-3718
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[email protected]
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05583344
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