GSK4532990 for Alcohol-related Liver Disease

(STARLIGHT Trial)

Recruiting at 69 trial locations

Overseen By EU GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Disqualifiers: Organ failure, Malignancy, Liver transplant, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

393 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.

Do I need to stop my current medications to join the trial?

The trial requires participants to have stable use of their current medications, so you may not need to stop taking them. However, it's best to discuss your specific medications with the study team.

What makes the drug GSK4532990 unique for treating alcohol-related liver disease?

GSK4532990 is a novel treatment for alcohol-related liver disease, which currently lacks many effective drug options. Unlike traditional treatments that focus on managing symptoms or complications, GSK4532990 may target specific pathways involved in the disease's progression, potentially offering a more direct approach to treatment. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 65 with alcohol-related liver disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD

Able and willing to comply with all study assessments and adhere to the protocol schedule of activities

I am able to understand and sign the consent form for this study.

Exclusion Criteria

Body Mass Index (BMI) >35 kg/m2 at screening

My blood pressure is not well controlled.

I have had a TIPSS procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GSK4532990 or placebo for 28 weeks to assess safety and efficacy in alcohol-related liver disease

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSK4532990

Trial Overview The study aims to test the safety and effectiveness of a new medication called GSK4532990 compared to a placebo in treating alcohol-related liver disease.

How Is the Trial Designed?

Group I: GSK4532990 Dose 4 Experimental Treatment 1 Intervention

Group II: GSK4532990 Dose 3 Experimental Treatment 1 Intervention

Group III: GSK4532990 Dose 2 Experimental Treatment 1 Intervention

Group IV: GSK4532990 Dose 1 Experimental Treatment 1 Intervention

Group V: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Characteristics of immune checkpoint regulators and potential role of soluble TIM-3 and LAG-3 in male patients with alcohol-associated liver disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Combined effect of ADH1B RS1229984, RS2066702 and ADH1C RS1693482/ RS698 alleles on alcoholism and chronic liver diseases. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Alcoholic liver disease: a synopsis of the Charles Lieber's Memorial Symposia 2009-2012. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

Alcoholic-related liver disease: pathogenesis, management and future therapeutic developments. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Polymorphisms of the glutathione S-transferases mu-1 (GSTM1) and theta-1 (GSTT1) and the risk of advanced alcoholic liver disease. [2019]