Status:
COMPLETED
Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH
Lead Sponsor:
GlaxoSmithKline
Conditions:
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 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®.
Key Trial Info
Start Date :
January 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2025
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06104319
Start Date
January 22 2024
End Date
September 23 2025
Last Update
October 14 2025
Active Locations (14)
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1
GSK Investigational Site
Chula Vista, California, United States, 91911
2
GSK Investigational Site
Montclair, California, United States, 91763
3
GSK Investigational Site
San Diego, California, United States, 91911
4
GSK Investigational Site
San Diego, California, United States, 91942