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New hope for NASH: drug targets liver scarring in advanced disease

NCT ID NCT05583344

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This study tests an experimental drug, GSK4532990, in 284 adults with nonalcoholic steatohepatitis (NASH) and advanced liver scarring. The goal is to see if the drug can improve liver fibrosis and inflammation compared to a placebo over 52 weeks. Participants must have a liver biopsy showing significant scarring and features of metabolic syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

284 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-alcoholic fatty liver disease Nonalcoholic fatty liver disease

Contacts and locations

Locations

  • GSK Investigational Site

    Homewood, Alabama, 35209-2629, United States

  • GSK Investigational Site

    Chandler, Arizona, 85224, United States

  • GSK Investigational Site

    Chandler, Arizona, 85712, United States

  • GSK Investigational Site

    Mesa, Arizona, 85381, United States

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401, United States

  • GSK Investigational Site

    North Little Rock, Arkansas, 72117, United States

  • GSK Investigational Site

    Huntington Park, California, 90255, United States

  • GSK Investigational Site

    La Jolla, California, 92037, United States

  • GSK Investigational Site

    Orange, California, 92866, United States

  • GSK Investigational Site

    Poway, California, 92064, United States

  • GSK Investigational Site

    Rialto, California, 92377, United States

  • GSK Investigational Site

    Sacramento, California, 95817, United States

  • GSK Investigational Site

    San Francisco, California, 94115, United States

  • GSK Investigational Site

    Santa Ana, California, 92704, United States

  • GSK Investigational Site

    Van Nuys, California, 91405, United States

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907, United States

  • GSK Investigational Site

    Bradenton, Florida, 34209, United States

  • GSK Investigational Site

    Coral Gables, Florida, 33134, United States

  • GSK Investigational Site

    Fort Myers, Florida, 33907, United States

  • GSK Investigational Site

    Hallandale, Florida, 33009, United States

  • GSK Investigational Site

    Hialeah, Florida, 33016, United States

  • GSK Investigational Site

    Homestead, Florida, 33032-8185, United States

  • GSK Investigational Site

    Jupiter, Florida, 33458, United States

  • GSK Investigational Site

    Lakewood Rch, Florida, 34211, United States

  • GSK Investigational Site

    Miami, Florida, 33122, United States

  • GSK Investigational Site

    Miami, Florida, 33126, United States

  • GSK Investigational Site

    Miami, Florida, 33176, United States

  • GSK Investigational Site

    Miami Lakes, Florida, 33016, United States

  • GSK Investigational Site

    West Palm Beach, Florida, 33401, United States

  • GSK Investigational Site

    Athens, Georgia, 30607, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30328, United States

  • GSK Investigational Site

    Marietta, Georgia, 30060, United States

  • GSK Investigational Site

    Snellville, Georgia, 30078, United States

  • GSK Investigational Site

    Indianapolis, Indiana, 46202, United States

  • GSK Investigational Site

    South Bend, Indiana, 46635-1557, United States

  • GSK Investigational Site

    Iowa City, Iowa, 52242, United States

  • GSK Investigational Site

    Topeka, Kansas, 66606, United States

  • GSK Investigational Site

    Bastrop, Louisiana, 71220-5035, United States

  • GSK Investigational Site

    Marrero, Louisiana, 70072, United States

  • GSK Investigational Site

    Metairie, Louisiana, 70006, United States

  • GSK Investigational Site

    Monroe, Louisiana, 71201, United States

  • GSK Investigational Site

    Shreveport, Louisiana, 71105, United States

  • GSK Investigational Site

    Columbia, Maryland, 21045, United States

  • GSK Investigational Site

    Greenbelt, Maryland, 20770, United States

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109-5000, United States

  • GSK Investigational Site

    Southfield, Michigan, 48075, United States

  • GSK Investigational Site

    Ypsilanti, Michigan, 48197, United States

  • GSK Investigational Site

    Chesterfield, Missouri, 48038, United States

  • GSK Investigational Site

    Las Vegas, Nevada, 89106, United States

  • GSK Investigational Site

    Princeton, New Jersey, 08648, United States

  • GSK Investigational Site

    Sparta, New Jersey, 07871, United States

  • GSK Investigational Site

    New York, New York, 10029, United States

  • GSK Investigational Site

    New York, New York, 10033, United States

  • GSK Investigational Site

    New York, New York, 10075-0999, United States

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • GSK Investigational Site

    Durham, North Carolina, 27710, United States

  • GSK Investigational Site

    Morehead City, North Carolina, 28557, United States

  • GSK Investigational Site

    Akron, Ohio, 44320, United States

  • GSK Investigational Site

    Springboro, Ohio, 45066, United States

  • GSK Investigational Site

    Westlake, Ohio, 44145-1493, United States

  • GSK Investigational Site

    Lancaster, Pennsylvania, 17604-3200, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213-3204, United States

  • GSK Investigational Site

    Wyomissing, Pennsylvania, 19610, United States

  • GSK Investigational Site

    Chattanooga, Tennessee, 37421-1605, United States

  • GSK Investigational Site

    Clarksville, Tennessee, 37040, United States

  • GSK Investigational Site

    Austin, Texas, 78757-8066, United States

  • GSK Investigational Site

    Brownsville, Texas, 78520, United States

  • GSK Investigational Site

    Dallas, Texas, 75203, United States

  • GSK Investigational Site

    Edinburg, Texas, 78539, United States

  • GSK Investigational Site

    Georgetown, Texas, 78626, United States

  • GSK Investigational Site

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    Houston, Texas, 77079, United States

  • GSK Investigational Site

    Houston, Texas, 77090, United States

  • GSK Investigational Site

    San Antonio, Texas, 78215, United States

  • GSK Investigational Site

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    Waco, Texas, 76710, United States

  • GSK Investigational Site

    West Jordan, Utah, 84088, United States

  • GSK Investigational Site

    Richmond, Virginia, 23229, United States

  • GSK Investigational Site

    Richmond, Virginia, 23236, United States

  • GSK Investigational Site

    Seattle, Washington, 98105-4093, United States

  • GSK Investigational Site

    Buenos Aires, C1061AAS, Argentina

  • GSK Investigational Site

    Capital Federal, C1181ACH, Argentina

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, 1118, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABJ, Argentina

  • GSK Investigational Site

    Derqui Pilar, B1629AHJ, Argentina

  • GSK Investigational Site

    Rosario, 3000, Argentina

  • GSK Investigational Site

    San Miguel de Tucumán, T4000IHE, Argentina

  • GSK Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • GSK Investigational Site

    Perth, Western Australia, 6000, Australia

  • GSK Investigational Site

    Brussels, 1070, Belgium

  • GSK Investigational Site

    Brussels, 1200, Belgium

  • GSK Investigational Site

    Edegem, 2650, Belgium

  • GSK Investigational Site

    Calgary, Alberta, T2N 4Z6, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2C4, Canada

  • GSK Investigational Site

    Angers, 49933, France

  • GSK Investigational Site

    Limoges, 87042, France

  • GSK Investigational Site

    Paris, 75651, France

  • GSK Investigational Site

    Pierre-Bénite, 69310, France

  • GSK Investigational Site

    Strasbourg, 67091, France

  • GSK Investigational Site

    Athens, 11527, Greece

  • GSK Investigational Site

    Rio Patras, 26504, Greece

  • GSK Investigational Site

    Thessaloniki, 546 42, Greece

  • GSK Investigational Site

    Thessaloniki, 54642, Greece

  • GSK Investigational Site

    Bhubaneswar, 751019, India

  • GSK Investigational Site

    Chandigarh, 160062, India

  • GSK Investigational Site

    Coimbatore, 641005, India

  • GSK Investigational Site

    Guhawati, 781006, India

  • GSK Investigational Site

    Mumbai, 400012, India

  • GSK Investigational Site

    Nagpur, 441108, India

  • GSK Investigational Site

    New Delhi, 110070, India

  • GSK Investigational Site

    Secunderabad, 500003, India

  • GSK Investigational Site

    Surat, 395009, India

  • GSK Investigational Site

    Florence, 50139, Italy

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Modena, 41126, Italy

  • GSK Investigational Site

    Padova, 35128, Italy

  • GSK Investigational Site

    Palermo, 90127, Italy

  • GSK Investigational Site

    Roma, 00168, Italy

  • GSK Investigational Site

    Rozzano MI, 20089, Italy

  • GSK Investigational Site

    San Giovanni Rotondo FG, 71013, Italy

  • GSK Investigational Site

    Fukui, 918-8503, Japan

  • GSK Investigational Site

    Fukuoka, 830-0011, Japan

  • GSK Investigational Site

    Gifu, 500-8513, Japan

  • GSK Investigational Site

    Gifu, 500-8717, Japan

  • GSK Investigational Site

    Gifu, 501-6062, Japan

  • GSK Investigational Site

    Gifu, 503-8502, Japan

  • GSK Investigational Site

    Hiroshima, 734-8551, Japan

  • GSK Investigational Site

    Kagawa, 760-0017, Japan

  • GSK Investigational Site

    Kagawa, 760-8557, Japan

  • GSK Investigational Site

    Kagawa, 761-0793, Japan

  • GSK Investigational Site

    Kagoshima, 890-8520, Japan

  • GSK Investigational Site

    Kanagawa, 216-8511, Japan

  • GSK Investigational Site

    Kanagawa, 236-0004, Japan

  • GSK Investigational Site

    Kanagawa, 259-1143, Japan

  • GSK Investigational Site

    Nagano, 390-8621, Japan

  • GSK Investigational Site

    Nagasaki, 856-8562, Japan

  • GSK Investigational Site

    Nara, 634-8522, Japan

  • GSK Investigational Site

    Numakunai, 028-3695, Japan

  • GSK Investigational Site

    Okayama, 700-8505, Japan

  • GSK Investigational Site

    Osaka, 564-0013, Japan

  • GSK Investigational Site

    Saga, 849-8501, Japan

  • GSK Investigational Site

    Shimane, 693-8501, Japan

  • GSK Investigational Site

    Yamanashi, 409-3898, Japan

  • GSK Investigational Site

    Cuernavaca Morelos, 62170, Mexico

  • GSK Investigational Site

    Guadalajara, 44130, Mexico

  • GSK Investigational Site

    Mérida, 97070, Mexico

  • GSK Investigational Site

    Panama City, 07206, Panama

  • GSK Investigational Site

    Panama City, Panama

  • GSK Investigational Site

    San Juan, 00927, Puerto Rico

  • GSK Investigational Site

    Incheon, 22332, South Korea

  • GSK Investigational Site

    Seoul, 07061, South Korea

  • GSK Investigational Site

    Seoul, 156-755, South Korea

  • GSK Investigational Site

    Yongsan-Ku Seoul, South Korea

  • GSK Investigational Site

    Barcelona, 08035, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28222, Spain

  • GSK Investigational Site

    Málaga, 29010, Spain

  • GSK Investigational Site

    Sabadell Barcelona, 08208, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Seville, 41013, Spain

  • GSK Investigational Site

    Vigo, 36071, Spain

  • GSK Investigational Site

    Kocaeli, İzmit, 41380, Turkey (Türkiye)

  • GSK Investigational Site

    Ankara, 06800, Turkey (Türkiye)

  • GSK Investigational Site

    Rize, 53020, Turkey (Türkiye)

  • GSK Investigational Site

    Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

  • GSK Investigational Site

    Cannock, WS11 0BN, United Kingdom

  • GSK Investigational Site

    London, SE5 9RS, United Kingdom

  • GSK Investigational Site

    Manchester, M13 9NQ, United Kingdom

  • GSK Investigational Site

    Newcastle upon Tyne, NE7 7DN, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.