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Compares treatment options for Liver Diseases, Alcoholic
Official title 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
ClinicalTrials.gov ID: NCT06613698
What this study is testing
What is GSK4532990?
GSK4532990 is an investigational medicine, being studied as a potential treatment for liver diseases, alcoholic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- 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)...
- Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy...
- 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.
See the full eligibility 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
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Davis, California, United States
- Los Angeles, California, United States
- Brandon, Florida, United States
- Miami Lakes, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Topeka, Kansas, United States
- Marrero, Louisiana, United States
- Detroit, Michigan, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Arlington, Texas, United States
- Austin, Texas, United States
- Dallas, Texas, United States
+ 86 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Davis, California, United States; Los Angeles, California, United States; Brandon, Florida, United States and 100 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.