Phase 2b Study of GSK4532990 in Adults With NASH (HORIZON)

May 20, 2026 updated by: GlaxoSmithKline

17 β-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

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1061AAS
        • GSK Investigational Site
      • Capital Federal, Argentina, C1181ACH
        • GSK Investigational Site
      • Ciudad AutOnoma de Buenos Aire, Argentina, 1118
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno, Argentina, C1056ABJ
        • GSK Investigational Site
      • Pilar, Argentina, B1629AHJ
        • GSK Investigational Site
      • Rosario, Argentina, 3000
        • GSK Investigational Site
      • San Miguel de Tucumán, Argentina, T4000IHE
        • GSK Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
      • Perth, Western Australia, Australia, 6000
        • GSK Investigational Site
      • Brussels, Belgium, 1200
        • GSK Investigational Site
      • Brussels, Belgium, 1070
        • GSK Investigational Site
      • Edegem, Belgium, 2650
        • GSK Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • GSK Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • GSK Investigational Site
      • Angers, France, 49933
        • GSK Investigational Site
      • Limoges, France, 87042
        • GSK Investigational Site
      • Paris, France, 75651
        • GSK Investigational Site
      • Pierre-Bénite, France, 69310
        • GSK Investigational Site
      • Strasbourg, France, 67091
        • GSK Investigational Site
      • Athens, Greece, 11527
        • GSK Investigational Site
      • Rio Patras, Greece, 26504
        • GSK Investigational Site
      • Thessaloniki, Greece, 54642
        • GSK Investigational Site
      • Thessaloniki, Greece, 546 42
        • GSK Investigational Site
      • Bhubaneswar, India, 751019
        • GSK Investigational Site
      • Chandigarh, India, 160062
        • GSK Investigational Site
      • Coimbatore, India, 641005
        • GSK Investigational Site
      • Guhawati, India, 781006
        • GSK Investigational Site
      • Mumbai, India, 400012
        • GSK Investigational Site
      • Nagpur, India, 441108
        • GSK Investigational Site
      • New Delhi, India, 110070
        • GSK Investigational Site
      • Secunderabad, India, 500003
        • GSK Investigational Site
      • Surat, India, 395009
        • GSK Investigational Site
      • Florence, Italy, 50139
        • GSK Investigational Site
      • Milan, Italy, 20122
        • GSK Investigational Site
      • Modena, Italy, 41126
        • GSK Investigational Site
      • Padova, Italy, 35128
        • GSK Investigational Site
      • Palermo, Italy, 90127
        • GSK Investigational Site
      • Roma, Italy, 00168
        • GSK Investigational Site
      • Rozzano MI, Italy, 20089
        • GSK Investigational Site
      • San Giovanni Rotondo FG, Italy, 71013
        • GSK Investigational Site
      • Fukui, Japan, 918-8503
        • GSK Investigational Site
      • Fukuoka, Japan, 830-0011
        • GSK Investigational Site
      • Gifu, Japan, 500-8717
        • GSK Investigational Site
      • Gifu, Japan, 503-8502
        • GSK Investigational Site
      • Gifu, Japan, 501-6062
        • GSK Investigational Site
      • Gifu, Japan, 500-8513
        • GSK Investigational Site
      • Hiroshima, Japan, 734-8551
        • GSK Investigational Site
      • Kagawa, Japan, 761-0793
        • GSK Investigational Site
      • Kagawa, Japan, 760-8557
        • GSK Investigational Site
      • Kagawa, Japan, 760-0017
        • GSK Investigational Site
      • Kagoshima, Japan, 890-8520
        • GSK Investigational Site
      • Kanagawa, Japan, 236-0004
        • GSK Investigational Site
      • Kanagawa, Japan, 259-1143
        • GSK Investigational Site
      • Kanagawa, Japan, 216-8511
        • GSK Investigational Site
      • Nagano, Japan, 390-8621
        • GSK Investigational Site
      • Nagasaki, Japan, 856-8562
        • GSK Investigational Site
      • Nara, Japan, 634-8522
        • GSK Investigational Site
      • Numakunai, Japan, 028-3695
        • GSK Investigational Site
      • Okayama, Japan, 700-8505
        • GSK Investigational Site
      • Osaka, Japan, 564-0013
        • GSK Investigational Site
      • Saga, Japan, 849-8501
        • GSK Investigational Site
      • Shimane, Japan, 693-8501
        • GSK Investigational Site
      • Yamanashi, Japan, 409-3898
        • GSK Investigational Site
      • Cuernavaca Morelos, Mexico, 62170
        • GSK Investigational Site
      • Guadalajara, Mexico, 44130
        • GSK Investigational Site
      • Mérida, Mexico, 97070
        • GSK Investigational Site
      • Panama City, Panama
        • GSK Investigational Site
      • Panama City, Panama, 07206
        • GSK Investigational Site
      • San Juan, Puerto Rico, 00927
        • GSK Investigational Site
      • Incheon, South Korea, 22332
        • GSK Investigational Site
      • Seoul, South Korea, 07061
        • GSK Investigational Site
      • Seoul, South Korea, 156-755
        • GSK Investigational Site
      • Yongsan-Ku Seoul, South Korea
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Madrid, Spain, 28041
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Madrid, Spain, 28222
        • GSK Investigational Site
      • Málaga, Spain, 29010
        • GSK Investigational Site
      • Sabadell Barcelona, Spain, 08208
        • GSK Investigational Site
      • Santander, Spain, 39008
        • GSK Investigational Site
      • Seville, Spain, 41013
        • GSK Investigational Site
      • Vigo, Spain, 36071
        • GSK Investigational Site
      • Ankara, Turkey (Türkiye), 06800
        • GSK Investigational Site
      • Kocaeli, Turkey (Türkiye), 41380
        • GSK Investigational Site
      • Rize, Turkey (Türkiye), 53200
        • GSK Investigational Site
      • Cannock, United Kingdom, WS11 0BN
        • GSK Investigational Site
      • London, United Kingdom, SE5 9RS
        • GSK Investigational Site
      • Manchester, United Kingdom, M13 9NQ
        • GSK Investigational Site
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • GSK Investigational Site
      • Nottingham, United Kingdom, NG7 2UH
        • GSK Investigational Site
    • Alabama
      • Homewood, Alabama, United States, 35209
        • GSK Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • GSK Investigational Site
      • Chandler, Arizona, United States, 85712
        • GSK Investigational Site
      • Mesa, Arizona, United States, 85381
        • GSK Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • GSK Investigational Site
      • North Little Rock, Arkansas, United States, 72117
        • GSK Investigational Site
    • California
      • Huntington Park, California, United States, 90255
        • GSK Investigational Site
      • La Jolla, California, United States, 92037
        • GSK Investigational Site
      • Orange, California, United States, 92866
        • GSK Investigational Site
      • Poway, California, United States, 92064
        • GSK Investigational Site
      • Rialto, California, United States, 92377
        • GSK Investigational Site
      • Sacramento, California, United States, 95817
        • GSK Investigational Site
      • San Francisco, California, United States, 94115
        • GSK Investigational Site
      • Santa Ana, California, United States, 92704
        • GSK Investigational Site
      • Van Nuys, California, United States, 91405
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
    • Florida
      • Bradenton, Florida, United States, 34209
        • GSK Investigational Site
      • Coral Gables, Florida, United States, 33134
        • GSK Investigational Site
      • Fort Myers, Florida, United States, 33907
        • GSK Investigational Site
      • Hallandale, Florida, United States, 33009
        • GSK Investigational Site
      • Hialeah, Florida, United States, 33016
        • GSK Investigational Site
      • Homestead, Florida, United States, 33032
        • GSK Investigational Site
      • Jupiter, Florida, United States, 33458
        • GSK Investigational Site
      • Lakewood Rch, Florida, United States, 34211
        • GSK Investigational Site
      • Miami, Florida, United States, 33126
        • GSK Investigational Site
      • Miami, Florida, United States, 33176
        • GSK Investigational Site
      • Miami, Florida, United States, 33122
        • GSK Investigational Site
      • Miami Lakes, Florida, United States, 33016
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • GSK Investigational Site
    • Georgia
      • Athens, Georgia, United States, 30607
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30328
        • GSK Investigational Site
      • Marietta, Georgia, United States, 30060
        • GSK Investigational Site
      • Snellville, Georgia, United States, 30078
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
      • South Bend, Indiana, United States, 46635
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • GSK Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • GSK Investigational Site
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • GSK Investigational Site
      • Marrero, Louisiana, United States, 70072
        • GSK Investigational Site
      • Metairie, Louisiana, United States, 70006
        • GSK Investigational Site
      • Monroe, Louisiana, United States, 71201
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71105
        • GSK Investigational Site
    • Maryland
      • Columbia, Maryland, United States, 21045
        • GSK Investigational Site
      • Greenbelt, Maryland, United States, 20770
        • GSK Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • GSK Investigational Site
      • Southfield, Michigan, United States, 48075
        • GSK Investigational Site
      • Ypsilanti, Michigan, United States, 48197
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 48038
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • GSK Investigational Site
    • New Jersey
      • Princeton, New Jersey, United States, 08648
        • GSK Investigational Site
      • Sparta, New Jersey, United States, 07871
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10029
        • GSK Investigational Site
      • New York, New York, United States, 10075
        • GSK Investigational Site
      • New York, New York, United States, 10033
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • GSK Investigational Site
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Morehead City, North Carolina, United States, 28557
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44320
        • GSK Investigational Site
      • Springboro, Ohio, United States, 45066
        • GSK Investigational Site
      • Westlake, Ohio, United States, 44145
        • GSK Investigational Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604-3200
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • GSK Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • GSK Investigational Site
      • Clarksville, Tennessee, United States, 37040
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78757
        • GSK Investigational Site
      • Brownsville, Texas, United States, 78520
        • GSK Investigational Site
      • Dallas, Texas, United States, 75203
        • GSK Investigational Site
      • Edinburg, Texas, United States, 78539
        • GSK Investigational Site
      • Georgetown, Texas, United States, 78626
        • GSK Investigational Site
      • Houston, Texas, United States, 77030
        • GSK Investigational Site
      • Houston, Texas, United States, 77090
        • GSK Investigational Site
      • Houston, Texas, United States, 77079
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78215
        • GSK Investigational Site
      • Waco, Texas, United States, 76710
        • GSK Investigational Site
    • Utah
      • West Jordan, Utah, United States, 84088
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23229
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23236
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo will be administered.
Experimental: High Dose GSK4532990
GSK4532990 will be administered.
Experimental: Low Dose GSK4532990
GSK4532990 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - F3 Cohort
Time Frame: At Week 52
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.
At Week 52
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - F3 Cohort
Time Frame: At Week 52
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.
At Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - Pooled Cohort (F3 participants and F4 participants)
Time Frame: At Week 52
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.
At Week 52
Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - Pooled Cohort (F3 participants and F4 participants)
Time Frame: At Week 52
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.
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
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
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
Baseline (Day 1) and at Week 24 and 52
Change from baseline in Enhanced Liver Fibrosis (ELF) Score - F3 Cohort
Time Frame: Baseline (Day 1) and at Week 24 and 52
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.
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
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
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
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
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
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
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)
Time Frame: Baseline (Day 1) and at Week 24 and 52
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Actual)

January 31, 2026

Study Completion (Estimated)

April 5, 2027

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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