COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2a, Single Dose, Open-label, Dose Exploration Study to Assess the PK-PD Activity, Safety, and Tolerability of GSK4532990 in Adult. Participants With NASH or Suspected NASH

Quick Facts

Study Start:2024-01-22
Study Completion:2025-09-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06104319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be 18 to 75 years of age.
  2. * Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed for the study.
  3. * Participants who have proven diagnosis of NASH or suspected NASH based on defined study criteria.
  4. * Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
  1. * Cirrhosis or current unstable liver or biliary disease.
  2. * Other causes of liver disease including, but not limited to, alcohol-related liver disease, autoimmune disorders.
  3. * Known weight loss of ≥5% within 3 months prior to Screening.
  4. * Weight reduction surgery or procedures within 2 years of Screening.
  5. * Any contraindication to undergoing liver biopsy.
  6. * Any contraindication to undergoing Magnetic Resonance Imaging or FibroScan®.

Contacts and Locations

Study Locations (Sites)

GSK Investigational Site
Chula Vista, California, 91911
United States
GSK Investigational Site
Montclair, California, 91763
United States
GSK Investigational Site
San Diego, California, 91911
United States
GSK Investigational Site
San Diego, California, 91942
United States
GSK Investigational Site
Brandon, Florida, 33511
United States
GSK Investigational Site
Miami, Florida, 33155
United States
GSK Investigational Site
Miami, Florida, 33173
United States
GSK Investigational Site
Miami Lakes, Florida, 33014
United States
GSK Investigational Site
Indianapolis, Indiana, 46202
United States
GSK Investigational Site
El Dorado, Kansas, 67042
United States
GSK Investigational Site
Marrero, Louisiana, 70072
United States
GSK Investigational Site
Austin, Texas, 78745
United States
GSK Investigational Site
San Antonio, Texas, 78215
United States
GSK Investigational Site
San Antonio, Texas, 78240
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-22
Study Completion Date2025-09-23

Study Record Updates

Study Start Date2024-01-22
Study Completion Date2025-09-23

Terms related to this study

Keywords Provided by Researchers

  • GSK4532990
  • Non-alcoholic steatohepatitis (NASH)
  • Non-alcoholic fatty liver disease (NAFLD)
  • Suspected NASH

Additional Relevant MeSH Terms

  • Non-alcoholic Fatty Liver Disease