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

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.

Conditions

Non-alcoholic Fatty Liver Disease

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Non-alcoholic Fatty Liver Disease
Intervention / Treatment

-

Contacts and Locations

Chula Vista

GSK Investigational Site, Chula Vista, California, United States, 91911

Montclair

GSK Investigational Site, Montclair, California, United States, 91763

San Diego

GSK Investigational Site, San Diego, California, United States, 91911

San Diego

GSK Investigational Site, San Diego, California, United States, 91942

Brandon

GSK Investigational Site, Brandon, Florida, United States, 33511

Miami Lakes

GSK Investigational Site, Miami Lakes, Florida, United States, 33014

Miami

GSK Investigational Site, Miami, Florida, United States, 33155

Miami

GSK Investigational Site, Miami, Florida, United States, 33173

Indianapolis

GSK Investigational Site, Indianapolis, Indiana, United States, 46202

El Dorado

GSK Investigational Site, El Dorado, Kansas, United States, 67042

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant must be 18 to 75 years of age.
  • * Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed for the study.
  • * Participants who have proven diagnosis of NASH or suspected NASH based on defined study criteria.
  • * Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
  • * Cirrhosis or current unstable liver or biliary disease.
  • * Other causes of liver disease including, but not limited to, alcohol-related liver disease, 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®.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GlaxoSmithKline,

Study Record Dates

2025-08-29