A Phase 2 interventional study of GSK4532990 and Placebo in Nonalcoholic Fatty Liver Disease and Non-alcoholic Fatty Liver Disease, sponsored by GlaxoSmithKline. Active, not recruiting at 170 sites in 17 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
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.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's enrollment of 284 is above the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: GSK4532990
Drug: GSK4532990
Drug: Placebo
GSK4532990 will be administered.
Placebo will be administered.
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - F3 Cohort
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.
Time frame: At Week 52
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - F3 Cohort
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.
Time frame: At Week 52
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - Pooled Cohort (F3 participants and F4 participants)
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.
Time frame: At Week 52
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - Pooled Cohort (F3 participants and F4 participants)
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.
Time frame: At Week 52
Change from baseline in Pro-peptide of type III collagen (Pro-C3) - F3 Cohort
Time frame: Baseline (Day 1) and at Week 24 and 52
Change from baseline in liver fat using Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) - F3 Cohort
Time frame: Baseline (Day 1) and at Week 24 and 52
Change from baseline in Liver stiffness measurement (LSM) by Vibration-controlled transient elastography (VCTE) - F3 Cohort
Time frame: Baseline (Day 1) and at Week 24 and 52
Change from baseline in Enhanced Liver Fibrosis (ELF) Score - F3 Cohort
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.
Time frame: Baseline (Day 1) and at Week 24 and 52
Percentage of Participants Achieving ≥30% relative reduction in liver fat from baseline using MRI-PDFF at Week 24- F3 Cohort
Time frame: At Week 24
Percentage of Participants Achieving ≥30% relative reduction in liver fat from baseline using MRI-PDFF at Week 52 - F3 Cohort
Time frame: At Week 52
Change from Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl transferase (GGT) (Units Per Liter) - F3 Cohort
Time frame: Baseline (Day 1) and at Week 24 and 52
Change from baseline in Pro-peptide of type III collagen (Pro-C3) - Pooled Cohort (F3 participants and F4 participants)
Time frame: Baseline (Day 1) and at Week 24 and 52
Change from baseline in liver fat using Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) - Pooled Cohort (F3 participants and F4 participants)
Time frame: Baseline (Day 1) and at Week 24 and 52
Change from baseline in Liver stiffness measurement (LSM) by Vibration-controlled transient elastography (VCTE) - Pooled Cohort (F3 participants and F4 participants)
Time frame: Baseline (Day 1) and at Week 24 and 52
Change from baseline in Enhanced Liver Fibrosis (ELF) Score - Pooled Cohort (F3 participants and F4 participants)
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.
Time frame: Baseline (Day 1) and at Week 24 and 52
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)
Time frame: At Week 24
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)
Time frame: At Week 52
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)
Time frame: Baseline (Day 1) and at Week 24 and 52
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - F3 Cohort
Time frame: Up to Week 66
Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury) - F3 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in Vital Signs - Temperature (Celsius) - F3 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in Vital Signs - Heart Rate (Beats per minute) - F3 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in Vital Signs - Respiratory Rate (Breaths per minute) - F3 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - F3 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - F4 Cohort
Time frame: Up to Week 66
Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury) - F4 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in Vital Signs - Temperature (Celsius) - F4 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in Vital Signs - Heart Rate (Beats per minute) - F4 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in Vital Signs - Respiratory Rate (Breaths per minute) - F4 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - F4 Cohort
Time frame: Baseline (Day 1) and up to Week 52
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Pooled Cohort (F3 participants and F4 participants)
Time frame: Up to Week 66
Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury) - Pooled Cohort (F3 participants and F4 participants)
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in Vital Signs - Temperature (Celsius) - Pooled Cohort (F3 participants and F4 participants)
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in Vital Signs - Heart Rate (Beats per minute) - Pooled Cohort (F3 participants and F4 participants)
Time frame: Baseline (Day 1) and up to Week 52
Change from Baseline in Vital Signs - Respiratory Rate (Breaths per minute) - Pooled Cohort (F3 participants and F4 participants)
Time frame: Baseline (Day 1) and up to Week 52
Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - Pooled Cohort (F3 participants and F4 participants)
Time frame: Baseline (Day 1) and up to Week 52
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 - F3 Cohort
Time frame: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Maximum observed concentration (Cmax) of GSK4532990- F3 Cohort
Time frame: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Percentage of Participants with Anti-drug Antibodies (ADA) to GSK4532990- F3 Cohort
Time frame: Up to Week 52
Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 - F4 Cohort
Time frame: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Maximum observed concentration (Cmax) of GSK4532990- F4 Cohort
Time frame: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose
Percentage of Participants with Anti-drug Antibodies (ADA) to GSK4532990- F4 Cohort
Time frame: Up to Week 52
Showing the first 100 of 170 sites across 17 countries. Choose a country and city above to see the rest.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Jan 2026, 36 months.
Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 36 months is above that.
Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: GSK4532990
Non-alcoholic Fatty Liver Disease →