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Nonalcoholic Fatty Liver DiseasePhase 2HORIZONNCT05583344

Phase 2b Study of GSK4532990 in Adults With NASH

A Phase 2 study testing GSK4532990 in people with Nonalcoholic Fatty Liver Disease and Non-alcoholic Fatty Liver Disease, run by GlaxoSmithKline at 170 sites in 17 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
GSK4532990
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
284 participants
Where
170 sitesin 17 countries
Study dates
2 Jan 2023to 18 Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

170 sites in 17 countries.

170 sites in 17 countries

United States80 sites

  • GSK Investigational Site

    Akron, Ohio, 44320

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109-5000

  • GSK Investigational Site

    Athens, Georgia, 30607

  • GSK Investigational Site

    Atlanta, Georgia, 30328

  • GSK Investigational Site

    Austin, Texas, 78757-8066

  • GSK Investigational Site

    Bastrop, Louisiana, 71220-5035

  • GSK Investigational Site

    Bradenton, Florida, 34209

  • GSK Investigational Site

    Brownsville, Texas, 78520

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Chandler, Arizona, 85712

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Chattanooga, Tennessee, 37421-1605

  • GSK Investigational Site

    Chesterfield, Missouri, 48038

  • GSK Investigational Site

    Clarksville, Tennessee, 37040

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Columbia, Maryland, 21045

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Dallas, Texas, 75203

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Edinburg, Texas, 78539

  • GSK Investigational Site

    Fort Myers, Florida, 33907

  • GSK Investigational Site

    Georgetown, Texas, 78626

  • GSK Investigational Site

    Greenbelt, Maryland, 20770

  • GSK Investigational Site

    Hallandale, Florida, 33009

  • GSK Investigational Site

    Hialeah, Florida, 33016

  • GSK Investigational Site

    Homestead, Florida, 33032-8185

  • GSK Investigational Site

    Homewood, Alabama, 35209-2629

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77079

  • GSK Investigational Site

    Houston, Texas, 77090

  • GSK Investigational Site

    Huntington Park, California, 90255

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Jupiter, Florida, 33458

  • GSK Investigational Site

    La Jolla, California, 92037

  • GSK Investigational Site

    Lakewood Rch, Florida, 34211

  • GSK Investigational Site

    Lancaster, Pennsylvania, 17604-3200

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Marrero, Louisiana, 70072

  • GSK Investigational Site

    Mesa, Arizona, 85381

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Miami, Florida, 33122

  • GSK Investigational Site

    Miami, Florida, 33126

  • GSK Investigational Site

    Miami, Florida, 33176

  • GSK Investigational Site

    Miami Lakes, Florida, 33016

  • GSK Investigational Site

    Monroe, Louisiana, 71201

  • GSK Investigational Site

    Morehead City, North Carolina, 28557

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    New York, New York, 10033

  • GSK Investigational Site

    New York, New York, 10075-0999

  • GSK Investigational Site

    North Little Rock, Arkansas, 72117

  • GSK Investigational Site

    Orange, California, 92866

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213-3204

  • GSK Investigational Site

    Poway, California, 92064

  • GSK Investigational Site

    Princeton, New Jersey, 08648

  • GSK Investigational Site

    Rialto, California, 92377

  • GSK Investigational Site

    Richmond, Virginia, 23229

  • GSK Investigational Site

    Richmond, Virginia, 23236

  • GSK Investigational Site

    Sacramento, California, 95817

  • GSK Investigational Site

    San Antonio, Texas, 78215

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Francisco, California, 94115

  • GSK Investigational Site

    Santa Ana, California, 92704

  • GSK Investigational Site

    Seattle, Washington, 98105-4093

  • GSK Investigational Site

    Shreveport, Louisiana, 71105

  • GSK Investigational Site

    Snellville, Georgia, 30078

  • GSK Investigational Site

    South Bend, Indiana, 46635-1557

  • GSK Investigational Site

    Southfield, Michigan, 48075

  • GSK Investigational Site

    Sparta, New Jersey, 07871

  • GSK Investigational Site

    Springboro, Ohio, 45066

  • GSK Investigational Site

    Topeka, Kansas, 66606

  • GSK Investigational Site

    Van Nuys, California, 91405

  • GSK Investigational Site

    Waco, Texas, 76710

  • GSK Investigational Site

    West Jordan, Utah, 84088

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    Westlake, Ohio, 44145-1493

  • GSK Investigational Site

    Wyomissing, Pennsylvania, 19610

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197

Other trials in United States

Japan23 sites

  • GSK Investigational Site

    Fukui, 918-8503

  • GSK Investigational Site

    Fukuoka, 830-0011

  • GSK Investigational Site

    Gifu, 500-8513

  • GSK Investigational Site

    Gifu, 500-8717

  • GSK Investigational Site

    Gifu, 501-6062

  • GSK Investigational Site

    Gifu, 503-8502

  • GSK Investigational Site

    Hiroshima, 734-8551

  • GSK Investigational Site

    Kagawa, 760-0017

  • GSK Investigational Site

    Kagawa, 760-8557

  • GSK Investigational Site

    Kagawa, 761-0793

  • GSK Investigational Site

    Kagoshima, 890-8520

  • GSK Investigational Site

    Kanagawa, 216-8511

  • GSK Investigational Site

    Kanagawa, 236-0004

  • GSK Investigational Site

    Kanagawa, 259-1143

  • GSK Investigational Site

    Nagano, 390-8621

  • GSK Investigational Site

    Nagasaki, 856-8562

  • GSK Investigational Site

    Nara, 634-8522

  • GSK Investigational Site

    Numakunai, 028-3695

  • GSK Investigational Site

    Okayama, 700-8505

  • GSK Investigational Site

    Osaka, 564-0013

  • GSK Investigational Site

    Saga, 849-8501

  • GSK Investigational Site

    Shimane, 693-8501

  • GSK Investigational Site

    Yamanashi, 409-3898

Other trials in Japan

India9 sites

  • GSK Investigational Site

    Bhubaneswar, 751019

  • GSK Investigational Site

    Chandigarh, 160062

  • GSK Investigational Site

    Coimbatore, 641005

  • GSK Investigational Site

    Guhawati, 781006

  • GSK Investigational Site

    Mumbai, 400012

  • GSK Investigational Site

    Nagpur, 441108

  • GSK Investigational Site

    New Delhi, 110070

  • GSK Investigational Site

    Secunderabad, 500003

  • GSK Investigational Site

    Surat, 395009

Other trials in India

Spain9 sites

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28222

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Sabadell Barcelona, 08208

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Vigo, 36071

Other trials in Spain

Italy8 sites

  • GSK Investigational Site

    Florence, 50139

  • GSK Investigational Site

    Milan, 20122

  • GSK Investigational Site

    Modena, 41126

  • GSK Investigational Site

    Padova, 35128

  • GSK Investigational Site

    Palermo, 90127

  • GSK Investigational Site

    Roma, 00168

  • GSK Investigational Site

    Rozzano MI, 20089

  • GSK Investigational Site

    San Giovanni Rotondo FG, 71013

Other trials in Italy

Argentina7 sites

  • GSK Investigational Site

    Buenos Aires, C1061AAS

  • GSK Investigational Site

    Capital Federal, C1181ACH

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABJ

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, 1118

  • GSK Investigational Site

    Derqui Pilar, B1629AHJ

  • GSK Investigational Site

    Rosario, 3000

  • GSK Investigational Site

    San Miguel de Tucumán, T4000IHE

Other trials in Argentina

France5 sites

  • GSK Investigational Site

    Angers, 49933

  • GSK Investigational Site

    Limoges, 87042

  • GSK Investigational Site

    Paris, 75651

  • GSK Investigational Site

    Pierre-Bénite, 69310

  • GSK Investigational Site

    Strasbourg, 67091

Other trials in France

United Kingdom5 sites

  • GSK Investigational Site

    Cannock, WS11 0BN

  • GSK Investigational Site

    London, SE5 9RS

  • GSK Investigational Site

    Manchester, M13 9NQ

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN

  • GSK Investigational Site

    Nottingham, Nottinghamshire, NG7 2UH

Other trials in United Kingdom

Greece4 sites

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Rio Patras, 26504

  • GSK Investigational Site

    Thessaloniki, 546 42

  • GSK Investigational Site

    Thessaloniki, 54642

Other trials in Greece

South Korea4 sites

  • GSK Investigational Site

    Incheon, 22332

  • GSK Investigational Site

    Seoul, 07061

  • GSK Investigational Site

    Seoul, 156-755

  • GSK Investigational Site

    Yongsan-Ku Seoul

Other trials in South Korea

Belgium3 sites

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Edegem, 2650

Other trials in Belgium

Mexico3 sites

  • GSK Investigational Site

    Cuernavaca Morelos, 62170

  • GSK Investigational Site

    Guadalajara, 44130

  • GSK Investigational Site

    Mérida, 97070

Other trials in Mexico

Turkey (Türkiye)3 sites

  • GSK Investigational Site

    Ankara, 06800

  • GSK Investigational Site

    Kocaeli, İzmit, 41380

  • GSK Investigational Site

    Rize, 53020

Other trials in Turkey (Türkiye)

Australia2 sites

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Perth, Western Australia, 6000

Other trials in Australia

Canada2 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Panama2 sites

  • GSK Investigational Site

    Panama City, 07206

  • GSK Investigational Site

    Panama City

Other trials in Panama

Puerto Rico1 site

  • GSK Investigational Site

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
GSK4532990, Placebo
Keywords
17β-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON), GSK4532990, Non-alcoholic steatohepatitis (NASH), Non-alcoholic fatty liver disease (NAFLD)
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK4532990Drug

    GSK4532990 will be administered.

  • PlaceboDrug

    Placebo will be administered.

Study groups in NCT05583344
Study groupRoleWhat they receive
High Dose GSK4532990ExperimentalNot described
Receives: Drug: GSK4532990
Low Dose GSK4532990ExperimentalNot described
Receives: Drug: GSK4532990
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At Week 52

  2. 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.

    Measured: At Week 52

Secondary outcomes (40)

  1. 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.

    Measured: At Week 52

  2. 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.

    Measured: At Week 52

  3. Change from baseline in Pro-peptide of type III collagen (Pro-C3) - F3 Cohort

    Measured: Baseline (Day 1) and at Week 24 and 52

  4. Change from baseline in liver fat using Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) - F3 Cohort

    Measured: Baseline (Day 1) and at Week 24 and 52

  5. Change from baseline in Liver stiffness measurement (LSM) by Vibration-controlled transient elastography (VCTE) - F3 Cohort

    Measured: Baseline (Day 1) and at Week 24 and 52

  6. 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.

    Measured: Baseline (Day 1) and at Week 24 and 52

  7. Percentage of Participants Achieving ≥30% relative reduction in liver fat from baseline using MRI-PDFF at Week 24- F3 Cohort

    Measured: At Week 24

  8. Percentage of Participants Achieving ≥30% relative reduction in liver fat from baseline using MRI-PDFF at Week 52 - F3 Cohort

    Measured: At Week 52

  9. Change from Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl transferase (GGT) (Units Per Liter) - F3 Cohort

    Measured: Baseline (Day 1) and at Week 24 and 52

  10. Change from baseline in Pro-peptide of type III collagen (Pro-C3) - Pooled Cohort (F3 participants and F4 participants)

    Measured: Baseline (Day 1) and at Week 24 and 52

  11. Change from baseline in liver fat using Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) - Pooled Cohort (F3 participants and F4 participants)

    Measured: Baseline (Day 1) and at Week 24 and 52

  12. Change from baseline in Liver stiffness measurement (LSM) by Vibration-controlled transient elastography (VCTE) - Pooled Cohort (F3 participants and F4 participants)

    Measured: Baseline (Day 1) and at Week 24 and 52

  13. 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.

    Measured: Baseline (Day 1) and at Week 24 and 52

  14. 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)

    Measured: At Week 24

  15. 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)

    Measured: At Week 52

  16. 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)

    Measured: Baseline (Day 1) and at Week 24 and 52

  17. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - F3 Cohort

    Measured: Up to Week 66

  18. Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury) - F3 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  19. Change from Baseline in Vital Signs - Temperature (Celsius) - F3 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  20. Change from Baseline in Vital Signs - Heart Rate (Beats per minute) - F3 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  21. Change from Baseline in Vital Signs - Respiratory Rate (Breaths per minute) - F3 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  22. Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - F3 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  23. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - F4 Cohort

    Measured: Up to Week 66

  24. Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury) - F4 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  25. Change from Baseline in Vital Signs - Temperature (Celsius) - F4 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  26. Change from Baseline in Vital Signs - Heart Rate (Beats per minute) - F4 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  27. Change from Baseline in Vital Signs - Respiratory Rate (Breaths per minute) - F4 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  28. Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - F4 Cohort

    Measured: Baseline (Day 1) and up to Week 52

  29. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Pooled Cohort (F3 participants and F4 participants)

    Measured: Up to Week 66

  30. Change from Baseline in Vital Signs - Blood Pressure (millimeters of Mercury) - Pooled Cohort (F3 participants and F4 participants)

    Measured: Baseline (Day 1) and up to Week 52

  31. Change from Baseline in Vital Signs - Temperature (Celsius) - Pooled Cohort (F3 participants and F4 participants)

    Measured: Baseline (Day 1) and up to Week 52

  32. Change from Baseline in Vital Signs - Heart Rate (Beats per minute) - Pooled Cohort (F3 participants and F4 participants)

    Measured: Baseline (Day 1) and up to Week 52

  33. Change from Baseline in Vital Signs - Respiratory Rate (Breaths per minute) - Pooled Cohort (F3 participants and F4 participants)

    Measured: Baseline (Day 1) and up to Week 52

  34. Change From Baseline in Clinical Chemistry Parameter: total bilirubin, direct Bilirubin and creatinine (Micromoles per Liter) - Pooled Cohort (F3 participants and F4 participants)

    Measured: Baseline (Day 1) and up to Week 52

  35. Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 - F3 Cohort

    Measured: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

  36. Maximum observed concentration (Cmax) of GSK4532990- F3 Cohort

    Measured: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

  37. Percentage of Participants with Anti-drug Antibodies (ADA) to GSK4532990- F3 Cohort

    Measured: Up to Week 52

  38. Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of GSK4532990 - F4 Cohort

    Measured: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

  39. Maximum observed concentration (Cmax) of GSK4532990- F4 Cohort

    Measured: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours post dose

  40. Percentage of Participants with Anti-drug Antibodies (ADA) to GSK4532990- F4 Cohort

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2022
  2. Study start2 Jan 2023
  3. Primary completion31 Jan 2026
  4. Study completion18 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05583344
Sponsor's protocol ID
218672
Other IDs
2022-002538-14, 2023-507503-62-00, 2023
Acronym
HORIZON
Status last verified
Sep 2026
First submitted
13 Oct 2022
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK4532990 in people with Nonalcoholic Fatty Liver Disease and Non-alcoholic Fatty Liver Disease, run by GlaxoSmithKline at 170 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, Japan, India, Spain, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - F3 Cohort (time frame: At Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05583344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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