GSK4532990 for Alcohol-related Liver Disease

(STARLIGHT Trial)

Recruiting at 74 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?

This trial evaluates whether a new treatment, GSK4532990, is safe and effective for individuals with alcohol-related liver disease. It includes several groups testing different doses of the treatment and one group receiving a placebo (a substance with no active medicine) for comparison. Individuals with a history of drinking that aligns with the disease and who are stable on their current medications might be suitable candidates. The trial aims to determine if GSK4532990 can improve liver health in those affected by alcohol consumption. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

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.

Is there any evidence suggesting that GSK4532990 is likely to be safe for humans?

Research has shown that GSK4532990 is generally safe for people. The STARLIGHT study, which tested this treatment for liver problems caused by alcohol, found no safety issues. This is encouraging because participants taking GSK4532990 did not experience serious side effects.

Other studies on GSK4532990 for different liver issues, such as steatohepatitis, also support these safety findings. While every new treatment has some unknowns, current evidence suggests that GSK4532990 is safe for people, with no major problems reported so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcohol-related liver disease?

Researchers are excited about GSK4532990 for alcohol-related liver disease because it offers a novel approach compared to current treatments. Unlike standard therapies like corticosteroids and pentoxifylline, which mainly focus on reducing inflammation and improving liver function, GSK4532990 targets underlying mechanisms specific to alcohol-related damage. This treatment introduces a new active ingredient that could potentially address the root causes of liver disease rather than just managing symptoms. The potential for GSK4532990 to offer a more targeted and effective treatment option is what makes it a promising candidate in this field.

What evidence suggests that GSK4532990 might be an effective treatment for alcohol-related liver disease?

Research has shown that GSK4532990 might help people with alcohol-related liver disease by reducing liver fat and damage. Studies have found that this drug lowers a protein called HSD17B13, which plays a crucial role in liver health. Early findings suggest that GSK4532990 is safe and may improve liver conditions without introducing new safety issues. Although researchers are still studying it, initial results are promising for those with alcohol-related liver problems. Participants in this trial will receive different doses of GSK4532990 or a placebo to further evaluate its effectiveness and safety. ^{1 2 4 6 7}

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06613698

NCT06613698 | A Study to Investigate the Safety and ...

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

2.

clinicaltrials.cedars-sinai.edu

clinicaltrials.cedars-sinai.edu/view/222291

GSK4532990 for Steatohepatitis in Adults With Alcohol-related ...

This study aims to determine whether the study drug, GSK4532990, can improve ALD and reduce liver fatness by reducing the levels of HSD17B13 protein in the ...

3.

gsk.com

gsk.com/en-gb/media/press-releases/gsk-presents-data-from-its-advancing-liver-pipeline-at-aasld-2025/

GSK presents data from its advancing liver pipeline at ...

Preliminary findings from the GSK '990 STARLIGHT study in alcohol-associated liver disease (ALD), show no emerging safety concerns and ...

4.

clinicaltrials.eu

clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-gsk4532990-for-adults-aged-18-65-with-alcohol-related-liver-disease/

Study on the Safety and Effectiveness of GSK4532990 for ...

This study assesses the safety and effectiveness of GSK4532990A, a new injectable treatment by GlaxoSmithKline, in reducing liver damage in adults suffering ...

5.

arrowheadpharma.com

arrowheadpharma.com/news-press/arrowhead-presents-positive-interim-clinical-data-on-aro-hsd-treatment-in-patients-with-suspected-nash-at-easl-international-liver-congress/

Arrowhead Presents Positive Interim Clinical Data on ARO ...

The data demonstrate that ARO-HSD is the first investigational therapeutic to achieve robust reductions in messenger RNA (mRNA) and protein levels of hepatic ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36513186/

A phase I/II study of ARO-HSD, an RNA interference ...

This proof-of-concept study demonstrated that short-term treatment with ARO-HSD reduces hepatic HSD17β13 mRNA and protein expression.

7.

gsk.com

gsk.com/media/h4xhdiq1/gsk-presents-data-from-its-advancing-liver-pipeline-at-aasld-2025.pdf

Press release

Preliminary findings from the GSK '990 STARLIGHT study in alcohol-associated liver disease (ALD), show no emerging safety concerns and ...