Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH

Last updated: March 24, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

Liver Disease

Primary Biliary Cholangitis

Treatment

GSK4532990

Clinical Study ID

NCT06104319
218675
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated. The total study duration for each participant will be approximately 24-36 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be 18 to 75 years of age.

  • Participant must be capable of giving signed informed consent which includescompliance with the requirements and restrictions listed for the study.

  • Participants who have proven diagnosis of NASH or suspected NASH based on definedstudy criteria.

  • Participants must meet predefined stable use requirements of concomitant medicationsbased on study criteria.

Exclusion

Exclusion Criteria:

Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:

  • Cirrhosis or current unstable liver or biliary disease.

  • Other causes of liver disease including, but not limited to, alcohol-related liverdisease, autoimmune disorders.

  • Known weight loss of ≥5% within 3 months prior to Screening.

  • Weight reduction surgery or procedures within 2 years of Screening.

  • Any contraindication to undergoing liver biopsy.

  • Any contraindication to undergoing Magnetic Resonance Imaging or FibroScan®.

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: GSK4532990
Phase: 2
Study Start date:
January 22, 2024
Estimated Completion Date:
September 23, 2025

Connect with a study center

  • GSK Investigational Site

    Chula Vista, California 91911
    United States

    Active - Recruiting

  • GSK Investigational Site

    Montclair, California 91763
    United States

    Active - Recruiting

  • GSK Investigational Site

    San Diego, California 91942
    United States

    Active - Recruiting

  • GSK Investigational Site

    Brandon, Florida 33511
    United States

    Active - Recruiting

  • GSK Investigational Site

    Miami, Florida 33173
    United States

    Active - Recruiting

  • GSK Investigational Site

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • GSK Investigational Site

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • GSK Investigational Site

    El Dorado, Kansas 67042
    United States

    Active - Recruiting

  • GSK Investigational Site

    Marrero, Louisiana 70072
    United States

    Active - Recruiting

  • GSK Investigational Site

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78745
    United States

    Active - Recruiting

  • GSK Investigational Site

    San Antonio, Texas 78240
    United States

    Active - Recruiting

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