Phase 2b Study of GSK4532990 in Adults With NASH

NCT05583344 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2186722022-002538-142023-507503-62-00
• Study Type: interventional
• Target: 284
• Locations: 17 countries
• Sites: 170

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

17β-Hydroxysteroid Dehydrogenase type 13 Minimization for the treatment of NASH (HORIZON); GSK4532990; Non-alcoholic steatohepatitis (NASH); Non-alcoholic fatty liver disease (NAFLD)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At Week 52

Secondary Outcomes (40)

• Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - Pooled Cohort (F3 participants and F4 participants)

  At Week 52

• Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - Pooled Cohort (F3 participants and F4 participants)

  At Week 52

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

  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

  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

  Baseline (Day 1) and at Week 24 and 52

Study Arms (3)

High Dose GSK4532990

EXPERIMENTAL

Drug: GSK4532990

Low Dose GSK4532990

EXPERIMENTAL

Drug: GSK4532990

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GSK4532990 DRUG

GSK4532990 will be administered.

High Dose GSK4532990; Low Dose GSK4532990

Placebo DRUG

Placebo will be administered.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (170)

GSK Investigational Site

Homewood, Alabama, 35209, United States

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GSK Investigational Site

Chandler, Arizona, 85224, United States

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GSK Investigational Site

Chandler, Arizona, 85712, United States

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GSK Investigational Site

Mesa, Arizona, 85381, United States

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GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

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GSK Investigational Site

North Little Rock, Arkansas, 72117, United States

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GSK Investigational Site

Huntington Park, California, 90255, United States

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GSK Investigational Site

La Jolla, California, 92037, United States

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GSK Investigational Site

Orange, California, 92866, United States

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GSK Investigational Site

Poway, California, 92064, United States

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GSK Investigational Site

Rialto, California, 92377, United States

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GSK Investigational Site

Sacramento, California, 95817, United States

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GSK Investigational Site

San Francisco, California, 94115, United States

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GSK Investigational Site

Santa Ana, California, 92704, United States

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GSK Investigational Site

Van Nuys, California, 91405, United States

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GSK Investigational Site

Colorado Springs, Colorado, 80907, United States

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GSK Investigational Site

Bradenton, Florida, 34209, United States

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GSK Investigational Site

Coral Gables, Florida, 33134, United States

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GSK Investigational Site

Fort Myers, Florida, 33907, United States

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GSK Investigational Site

Hallandale, Florida, 33009, United States

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GSK Investigational Site

Hialeah, Florida, 33016, United States

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GSK Investigational Site

Homestead, Florida, 33032, United States

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GSK Investigational Site

Jupiter, Florida, 33458, United States

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GSK Investigational Site

Lakewood Rch, Florida, 34211, United States

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GSK Investigational Site

Miami, Florida, 33122, United States

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GSK Investigational Site

Miami, Florida, 33126, United States

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GSK Investigational Site

Miami, Florida, 33176, United States

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GSK Investigational Site

Miami Lakes, Florida, 33016, United States

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GSK Investigational Site

West Palm Beach, Florida, 33401, United States

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GSK Investigational Site

Athens, Georgia, 30607, United States

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GSK Investigational Site

Atlanta, Georgia, 30328, United States

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GSK Investigational Site

Marietta, Georgia, 30060, United States

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GSK Investigational Site

Snellville, Georgia, 30078, United States

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GSK Investigational Site

Indianapolis, Indiana, 46202, United States

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GSK Investigational Site

South Bend, Indiana, 46635, United States

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GSK Investigational Site

Iowa City, Iowa, 52242, United States

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GSK Investigational Site

Topeka, Kansas, 66606, United States

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GSK Investigational Site

Bastrop, Louisiana, 71220, United States

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GSK Investigational Site

Marrero, Louisiana, 70072, United States

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GSK Investigational Site

Metairie, Louisiana, 70006, United States

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GSK Investigational Site

Monroe, Louisiana, 71201, United States

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GSK Investigational Site

Shreveport, Louisiana, 71105, United States

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GSK Investigational Site

Columbia, Maryland, 21045, United States

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GSK Investigational Site

Greenbelt, Maryland, 20770, United States

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GSK Investigational Site

Ann Arbor, Michigan, 48109, United States

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GSK Investigational Site

Southfield, Michigan, 48075, United States

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GSK Investigational Site

Ypsilanti, Michigan, 48197, United States

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GSK Investigational Site

Chesterfield, Missouri, 48038, United States

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GSK Investigational Site

Las Vegas, Nevada, 89106, United States

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GSK Investigational Site

Princeton, New Jersey, 08648, United States

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GSK Investigational Site

Sparta, New Jersey, 07871, United States

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GSK Investigational Site

New York, New York, 10029, United States

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GSK Investigational Site

New York, New York, 10033, United States

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GSK Investigational Site

New York, New York, 10075, United States

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GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

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GSK Investigational Site

Durham, North Carolina, 27710, United States

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GSK Investigational Site

Morehead City, North Carolina, 28557, United States

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GSK Investigational Site

Akron, Ohio, 44320, United States

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GSK Investigational Site

Springboro, Ohio, 45066, United States

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GSK Investigational Site

Westlake, Ohio, 44145, United States

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GSK Investigational Site

Lancaster, Pennsylvania, 17604-3200, United States

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Pittsburgh, Pennsylvania, 15213, United States

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GSK Investigational Site

Wyomissing, Pennsylvania, 19610, United States

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GSK Investigational Site

Chattanooga, Tennessee, 37421, United States

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GSK Investigational Site

Clarksville, Tennessee, 37040, United States

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GSK Investigational Site

Austin, Texas, 78757, United States

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GSK Investigational Site

Brownsville, Texas, 78520, United States

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GSK Investigational Site

Dallas, Texas, 75203, United States

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GSK Investigational Site

Edinburg, Texas, 78539, United States

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GSK Investigational Site

Georgetown, Texas, 78626, United States

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GSK Investigational Site

Houston, Texas, 77030, United States

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GSK Investigational Site

Houston, Texas, 77079, United States

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GSK Investigational Site

Houston, Texas, 77090, United States

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GSK Investigational Site

San Antonio, Texas, 78215, United States

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GSK Investigational Site

San Antonio, Texas, 78229, United States

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GSK Investigational Site

Waco, Texas, 76710, United States

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GSK Investigational Site

West Jordan, Utah, 84088, United States

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GSK Investigational Site

Richmond, Virginia, 23229, United States

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GSK Investigational Site

Richmond, Virginia, 23236, United States

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GSK Investigational Site

Seattle, Washington, 98105, United States

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GSK Investigational Site

Buenos Aires, C1061AAS, Argentina

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GSK Investigational Site

Capital Federal, C1181ACH, Argentina

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GSK Investigational Site

Ciudad AutOnoma de Buenos Aire, 1118, Argentina

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GSK Investigational Site

Ciudad Autonoma de Bueno, C1056ABJ, Argentina

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GSK Investigational Site

Pilar, B1629AHJ, Argentina

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GSK Investigational Site

Rosario, 3000, Argentina

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GSK Investigational Site

San Miguel de Tucumán, T4000IHE, Argentina

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GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

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GSK Investigational Site

Perth, Western Australia, 6000, Australia

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GSK Investigational Site

Brussels, 1070, Belgium

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GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Edegem, 2650, Belgium

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GSK Investigational Site

Calgary, Alberta, T2N 4Z6, Canada

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Toronto, Ontario, M5G 2C4, Canada

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GSK Investigational Site

Angers, 49933, France

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GSK Investigational Site

Limoges, 87042, France

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GSK Investigational Site

Paris, 75651, France

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GSK Investigational Site

Pierre-Bénite, 69310, France

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GSK Investigational Site

Strasbourg, 67091, France

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GSK Investigational Site

Athens, 11527, Greece

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GSK Investigational Site

Rio Patras, 26504, Greece

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GSK Investigational Site

Thessaloniki, 546 42, Greece

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GSK Investigational Site

Thessaloniki, 54642, Greece

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GSK Investigational Site

Bhubaneswar, 751019, India

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GSK Investigational Site

Chandigarh, 160062, India

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GSK Investigational Site

Coimbatore, 641005, India

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GSK Investigational Site

Guhawati, 781006, India

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GSK Investigational Site

Mumbai, 400012, India

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GSK Investigational Site

Nagpur, 441108, India

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GSK Investigational Site

New Delhi, 110070, India

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GSK Investigational Site

Secunderabad, 500003, India

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GSK Investigational Site

Surat, 395009, India

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GSK Investigational Site

Florence, 50139, Italy

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GSK Investigational Site

Milan, 20122, Italy

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GSK Investigational Site

Modena, 41126, Italy

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GSK Investigational Site

Padua, 35128, Italy

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GSK Investigational Site

Palermo, 90127, Italy

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GSK Investigational Site

Roma, 00168, Italy

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GSK Investigational Site

Rozzano MI, 20089, Italy

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GSK Investigational Site

San Giovanni Rotondo FG, 71013, Italy

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GSK Investigational Site

Fukui, 918-8503, Japan

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GSK Investigational Site

Fukuoka, 830-0011, Japan

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GSK Investigational Site

Gifu, 500-8513, Japan

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GSK Investigational Site

Gifu, 500-8717, Japan

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GSK Investigational Site

Gifu, 501-6062, Japan

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GSK Investigational Site

Gifu, 503-8502, Japan

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GSK Investigational Site

Hiroshima, 734-8551, Japan

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GSK Investigational Site

Kagawa, 760-0017, Japan

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GSK Investigational Site

Kagawa, 760-8557, Japan

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GSK Investigational Site

Kagawa, 761-0793, Japan

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GSK Investigational Site

Kagoshima, 890-8520, Japan

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GSK Investigational Site

Kanagawa, 216-8511, Japan

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GSK Investigational Site

Kanagawa, 236-0004, Japan

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GSK Investigational Site

Kanagawa, 259-1143, Japan

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GSK Investigational Site

Nagano, 390-8621, Japan

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GSK Investigational Site

Nagasaki, 856-8562, Japan

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GSK Investigational Site

Nara, 634-8522, Japan

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GSK Investigational Site

Numakunai, 028-3695, Japan

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GSK Investigational Site

Okayama, 700-8505, Japan

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GSK Investigational Site

Osaka, 564-0013, Japan

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GSK Investigational Site

Saga, 849-8501, Japan

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GSK Investigational Site

Shimane, 693-8501, Japan

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GSK Investigational Site

Yamanashi, 409-3898, Japan

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GSK Investigational Site

Cuernavaca Morelos, 62170, Mexico

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GSK Investigational Site

Guadalajara, 44130, Mexico

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GSK Investigational Site

Mérida, 97070, Mexico

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GSK Investigational Site

Panama City, 07206, Panama

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GSK Investigational Site

Panama City, Panama

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GSK Investigational Site

San Juan, 00927, Puerto Rico

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GSK Investigational Site

Incheon, 22332, South Korea

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GSK Investigational Site

Seoul, 07061, South Korea

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GSK Investigational Site

Seoul, 156-755, South Korea

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GSK Investigational Site

Yongsan-Ku Seoul, South Korea

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28222, Spain

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GSK Investigational Site

Málaga, 29010, Spain

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GSK Investigational Site

Sabadell Barcelona, 08208, Spain

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GSK Investigational Site

Santander, 39008, Spain

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GSK Investigational Site

Seville, 41013, Spain

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GSK Investigational Site

Vigo, 36071, Spain

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GSK Investigational Site

Ankara, 06800, Turkey (Türkiye)

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GSK Investigational Site

Kocaeli, 41380, Turkey (Türkiye)

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GSK Investigational Site

Rize, 53200, Turkey (Türkiye)

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GSK Investigational Site

Cannock, WS11 0BN, United Kingdom

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GSK Investigational Site

London, SE5 9RS, United Kingdom

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GSK Investigational Site

Manchester, M13 9NQ, United Kingdom

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GSK Investigational Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

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GSK Investigational Site

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: January 2, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): April 5, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

AR (7); US (80); PA (2); JP (23); ME (3); TU (3); GB (5); AU (2); FR (5); CA (2); IT (8); PR (1); IN (9); GR (4); BE (3); ES (9); KR (4)