Clinical Trials in Mexico / 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 Mexico 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 Mexico
Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM
Active, not recruiting
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 Mexico