Phase 2b Study of GSK4532990 in Adults With NASH

NCT ID: NCT05583344

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2027-04-05

Brief Summary

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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.

Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High Dose GSK4532990

Group Type EXPERIMENTAL

GSK4532990

Intervention Type DRUG

GSK4532990 will be administered.

Low Dose GSK4532990

Group Type EXPERIMENTAL

GSK4532990

Intervention Type DRUG

GSK4532990 will be administered.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered.

Interventions

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GSK4532990

GSK4532990 will be administered.

Intervention Type DRUG

Placebo

Placebo will be administered.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Homewood, Alabama, United States

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Chandler, Arizona, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Jonesboro, Arkansas, United States

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North Little Rock, Arkansas, United States

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Huntington Park, California, United States

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La Jolla, California, United States

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Orange, California, United States

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Poway, California, United States

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Rialto, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Santa Ana, California, United States

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Van Nuys, California, United States

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Colorado Springs, Colorado, United States

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Bradenton, Florida, United States

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Coral Gables, Florida, United States

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Fort Myers, Florida, United States

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Hallandale, Florida, United States

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Hialeah, Florida, United States

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Homestead, Florida, United States

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Jupiter, Florida, United States

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Lakewood Rch, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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West Palm Beach, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Snellville, Georgia, United States

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Indianapolis, Indiana, United States

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South Bend, Indiana, United States

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Iowa City, Iowa, United States

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Topeka, Kansas, United States

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Bastrop, Louisiana, United States

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Marrero, Louisiana, United States

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Marrero, Louisiana, United States

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Monroe, Louisiana, United States

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Shreveport, Louisiana, United States

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Columbia, Maryland, United States

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Greenbelt, Maryland, United States

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Ann Arbor, Michigan, United States

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Southfield, Michigan, United States

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Ypsilanti, Michigan, United States

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Chesterfield, Missouri, United States

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Las Vegas, Nevada, United States

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Princeton, New Jersey, United States

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Sparta, New Jersey, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Morehead City, North Carolina, United States

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Raleigh, North Carolina, United States

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Akron, Ohio, United States

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Springboro, Ohio, United States

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Westlake, Ohio, United States

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Lancaster, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Clarksville, Tennessee, United States

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Austin, Texas, United States

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Brownsville, Texas, United States

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Dallas, Texas, United States

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Edinburg, Texas, United States

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Georgetown, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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West Jordan, Utah, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Buenos Aires, , Argentina

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Capital Federal, , Argentina

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Ciudad AutOnoma de Buenos Aire, , Argentina

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Ciudad Autonoma de Bueno, , Argentina

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Pilar, , Argentina

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Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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Nedlands, Western Australia, Australia

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Perth, Western Australia, Australia

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Brussels, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Calgary, Alberta, Canada

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Toronto, Ontario, Canada

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Angers, , France

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Limoges, , France

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Paris, , France

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Pierre-Bénite, , France

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Strasbourg, , France

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Athens, , Greece

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Rio Patras, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Bhubaneswar, , India

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Chandigarh, , India

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Coimbatore, , India

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Guhawati, , India

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Mumbai, , India

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Nagpur, , India

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New Delhi, , India

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Secunderabad, , India

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Surat, , India

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Florence, , Italy

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Milan, , Italy

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Modena, , Italy

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Padua, , Italy

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Palermo, , Italy

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Roma, , Italy

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Rozzano MI, , Italy

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San Giovanni Rotondo FG, , Italy

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Fukui, , Japan

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Fukuoka, , Japan

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Gifu, , Japan

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Gifu, , Japan

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Gifu, , Japan

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Gifu, , Japan

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Hiroshima, , Japan

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Kagawa, , Japan

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Kagawa, , Japan

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Kagawa, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Kanagawa, , Japan

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Nagano, , Japan

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Nagasaki, , Japan

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Nara, , Japan

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Numakunai, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Saga, , Japan

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Shimane, , Japan

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Yamanashi, , Japan

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Cuernavaca Morelos, , Mexico

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Guadalajara, , Mexico

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Mérida, , Mexico

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Panama City, , Panama

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Panama City, , Panama

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San Juan, , Puerto Rico

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Incheon, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Yongsan-Ku Seoul, , South Korea

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Sabadell Barcelona, , Spain

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Santander, , Spain

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Seville, , Spain

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Vigo, , Spain

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Ankara, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Rize, , Turkey (Türkiye)

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Cannock, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Nottingham, , United Kingdom

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Countries

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United States Argentina Australia Belgium Canada France Greece India Italy Japan Mexico Panama Puerto Rico South Korea Spain Turkey (Türkiye) United Kingdom

Other Identifiers

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2022-002538-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-507503-62-00

Identifier Type: OTHER

Identifier Source: secondary_id

218672

Identifier Type: -

Identifier Source: org_study_id

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