GSK4532990 for NASH

(HORIZON Trial)

Recruiting at 185 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Disqualifiers: Alcohol use, Weight reduction surgery, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

271 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called GSK4532990 to see if it can help people with severe liver damage caused by NASH. The drug aims to reduce liver scarring and swelling. The study will last over a year, with about a year of treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

Adults with a liver condition called NASH and advanced fibrosis can join this trial. They must have a BMI of at least 25, or 23 for Asian participants, and show certain features on a liver biopsy. Participants need to be able to follow the study plan, including another biopsy after one year. People who've had weight reduction surgery recently, have cirrhosis, drink heavily, or had cancer (except some skin cancers) in the last two years cannot join.

Inclusion Criteria

My liver biopsy shows I have significant fatty liver disease with inflammation and scarring.

Able and willing to comply with all study assessments, including a liver biopsy at Week 52

Body Mass Index (BMI) ≥25 kg/m^2 (all ethnic origins) except for Asian participants who qualify for the study with BMI ≥23 kg/m^2 at Screening

Exclusion Criteria

Current alcohol consumption ≥14 standard drinks (24 units, 196 g ethanol) per week for females or ≥21 standard drinks (37 units, 294g ethanol) per week for males

I have been diagnosed with cirrhosis through a biopsy.

I have not had weight loss surgery in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 24 weeks

Treatment

Participants receive GSK4532990 or placebo for the treatment of NASH

52 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GSK4532990
• Placebo

Trial Overview The trial is testing GSK4532990 against a placebo to see if it's better at reducing liver scarring and inflammation in people with NASH. Everyone will be randomly assigned to either get GSK4532990 or a dummy pill (placebo), and they won't know which one they're taking for up to 52 weeks of treatment.

How Is the Trial Designed?

Group I: Low Dose GSK4532990 Experimental Treatment 1 Intervention

Group II: High Dose GSK4532990 Experimental Treatment 1 Intervention

Group III: 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