Exploring the effects of GSK4532990 in patients with NASH
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
This study is testing a new drug called GSK4532990 to see if it is safe and how it works in people with non-alcoholic steatohepatitis (NASH) over about 24-36 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Locations | 14 sites (Chula Vista, California and 13 other locations) |
| Trial ID | NCT06104319 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the pharmacokinetics and pharmacodynamics of the drug GSK4532990 in individuals diagnosed with non-alcoholic steatohepatitis (NASH) or suspected NASH. Participants will receive the drug over a period of approximately 24-36 weeks to assess its safety, tolerability, and how it is processed by the body. The study will include various assessments to monitor liver function and overall health during the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of NASH or suspected NASH.
Not a fit: Patients with cirrhosis, unstable liver disease, or other significant liver conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from NASH, potentially improving liver health and overall outcomes.
How similar studies have performed: While this approach is being explored in this specific context, similar studies targeting NASH have shown promise in the past, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. 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 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®.
Where this trial is running
Chula Vista, California and 13 other locations
- GSK Investigational Site — Chula Vista, California, United States (Recruiting)
- GSK Investigational Site — Montclair, California, United States (Recruiting)
- GSK Investigational Site — San Diego, California, United States (Recruiting)
- GSK Investigational Site — San Diego, California, United States (Recruiting)
- GSK Investigational Site — Brandon, Florida, United States (Recruiting)
- GSK Investigational Site — Miami Lakes, Florida, United States (Recruiting)
- GSK Investigational Site — Miami, Florida, United States (Recruiting)
- GSK Investigational Site — Miami, Florida, United States (Recruiting)
- GSK Investigational Site — Indianapolis, Indiana, United States (Recruiting)
- GSK Investigational Site — El Dorado, Kansas, United States (Recruiting)
- GSK Investigational Site — Marrero, Louisiana, United States (Recruiting)
- GSK Investigational Site — Austin, Texas, United States (Recruiting)
- GSK Investigational Site — San Antonio, Texas, United States (Recruiting)
- GSK Investigational Site — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.