Clinical Trials in Sweden / NCT06613698
Recruiting
Phase 2
A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease
NCT06613698 · tracked via the Priya Life Science Sweden tracker
Condition(s) studied
Liver Diseases, Alcoholic
Investigational drug(s) / intervention(s)
GSK4532990 →Placebo
GSK4532990: GSK4532990 will be administered
Placebo: Placebo will be administered
Study summary
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Eligibility
Inclusion Criteria:
* Capable of giving signed informed consent prior to the performance of any study-specific procedures.
* Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
* In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD.
* A female participant is eligible to participate after meeting additional pre-defined criteria.
* Participants must meet predefined stable use requirements of concomitant medications based on study criteria.
* Participant has advanced chronic liver disease
Exclusion Criteria:
* Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD)
* Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria.
* Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible.
* Prior organ transplant or current listing or active consideration for organ transplant during the screening period (except for corneal transplants).
* Chronic or acute, including partial, known portal vein thrombosis.
* Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion.
* Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening.
* Poorly controlled hypertension
* Clinical suspicion of rhabdomyolysis during the screening period
* Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and/or low blood fibrinogen level.
* Body Mass Index (BMI) \>35 kg/m2 at screening
* Any liver-related clinical event that started (onset) \<8 weeks prior to Baseline (D1).
Primary outcome measure(s)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) — Up to 8 weeks
- Number of participants with potentially clinically relevant changes in electrocardiogram (ECG), vital signs, and clinical laboratory tests — Up to 8 weeks
- Change from baseline in Liver Stiffness measurement (LSM) reduction using FibroScan® at Week 52 (kiloPascal) — Baseline (Day 1) and up to Week 52
Liver stiffness will be measured by vibration-controlled transient elastography (VCTE) using the FibroScan® device. - Change from baseline in model for end-stage liver disease (MELD) score reduction at Week 52 — Baseline (Day 1) and up to Week 52
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
Trial sites (140)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Chandler | Arizona | Recruiting |
| GSK Investigational Site | Phoenix | Arizona | Recruiting |
| GSK Investigational Site | Tucson | Arizona | Recruiting |
| GSK Investigational Site | Tucson | Arizona | Recruiting |
| GSK Investigational Site | Coronado | California | Recruiting |
| GSK Investigational Site | Lancaster | California | Recruiting |
| GSK Investigational Site | Los Angeles | California | Recruiting |
| GSK Investigational Site | Los Angeles | California | Recruiting |
| GSK Investigational Site | Pasadena | California | Recruiting |
| GSK Investigational Site | Sacramento | California | Recruiting |
| GSK Investigational Site | Brandon | Florida | Recruiting |
| GSK Investigational Site | Miami | Florida | Recruiting |
| GSK Investigational Site | Miami Lakes | Florida | Recruiting |
| GSK Investigational Site | Atlanta | Georgia | Recruiting |
| GSK Investigational Site | Indianapolis | Indiana | Recruiting |
| GSK Investigational Site | Topeka | Kansas | Recruiting |
| GSK Investigational Site | Marrero | Louisiana | Recruiting |
| GSK Investigational Site | Detroit | Michigan | Recruiting |
| GSK Investigational Site | Las Vegas | Nevada | Recruiting |
| GSK Investigational Site | New York | New York | Recruiting |
| GSK Investigational Site | Chapel Hill | North Carolina | Recruiting |
| GSK Investigational Site | Cleveland | Ohio | Recruiting |
| GSK Investigational Site | Philadelphia | Pennsylvania | Recruiting |
| GSK Investigational Site | Hermitage | Tennessee | Recruiting |
| GSK Investigational Site | Arlington | Texas | Recruiting |
| GSK Investigational Site | Austin | Texas | Recruiting |
| GSK Investigational Site | Dallas | Texas | Recruiting |
| GSK Investigational Site | Dallas | Texas | Recruiting |
| GSK Investigational Site | Fort Worth | Texas | Recruiting |
| GSK Investigational Site | Georgetown | Texas | Recruiting |
| GSK Investigational Site | McAllen | Texas | Completed |
| GSK Investigational Site | San Antonio | Texas | Recruiting |
| GSK Investigational Site | Richmond | Virginia | Recruiting |
| GSK Investigational Site | Richmond | Virginia | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Buenos Aires | Argentina | Recruiting |
| GSK Investigational Site | Ciudad AutOnoma de Buenos Aire | Argentina | Recruiting |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aire | Argentina | Recruiting |
+ 100 more sites — see the full list on the official registry below.
More GlaxoSmithKline trials in Sweden
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06613698 on ClinicalTrials.gov ↗ ← All trials in Sweden